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American Pharmaceutical Association

The National Professional Society of Pharmacists

Background Information on Self-TreatingMusculoskeletal Pain and PrimaryDysmenorrhea and Use of ThermaCare®

Therapeutic HeatWraps

Answers to Patients’ Questions About Musculoskeletal Pain and PrimaryDysmenorrhea and ThermaCare®

Therapeutic HeatWraps

ThermaCare®

Therapeutic HeatWrapsINSIDE:

Dear Colleague:

Pain from musculoskeletal injuries (e.g., sprains, strains) and disorders (e.g., arthritis) and

primary dysmenorrhea (i.e., menstrual cramping pain) are common patient complaints that

can interfere with the activities of daily living. Because the pain usually is transient and

benign, it is amenable to self-treatment.

Patients often seek advice from pharmacists about how to self-treat pain from musculoskeletal

injuries and menstrual cramps. Patients may be confused about whether to apply heat or cold

to a sprained ankle, for example. Pharmacists can determine whether a patient with pain is a

good candidate for self-treatment and refer patients with signs and symptoms of a serious con-

dition to a physician, thereby avoiding further delay in diagnosis and treatment. For patients

whose condition seems minor, the pharmacist can recommend appropriate nondrug measures

and nonprescription drug products to alleviate pain.

ThermaCare® Therapeutic HeatWraps recently became available for the temporary relief of

minor muscle and joint aches and pain associated with overexertion, overuse, strains, sprains,

and arthritis. They also are indicated for the temporary relief of minor menstrual cramping

pain and associated backache. This New Product Bulletin provides a comprehensive description

of the mechanism of action, uses, administration, efficacy, adverse effects, cautions, and drug

interactions associated with the use of ThermaCare Therapeutic HeatWraps (additional infor-

mation about ThermaCare Therapeutic HeatWraps will be posted on the APhA Web site at

http://www.aphanet.org). The prevalence, epidemiology, economic impact, pathophysiology,

and self-treatment of pain from musculoskeletal injuries and disorders and primary dysmenor-

rhea are summarized. Answers to questions commonly asked by patients are provided; these

questions and answers may be photocopied for distribution to patients.

We hope that you find this publication useful.

Sincerely yours,

Arthur I. Jacknowitz, PharmD

Advisory Board Chairperson

This New Therapeutics Bulletin on ThermaCare® Therapeutic HeatWraps was developed by the AmericanPharmaceutical Association and supported by an educational grant from Procter & Gamble Health Care. Procter & Gamble Health Care is a Corporate Diamond Sponsor of the American Pharmaceutical Association Sesquicentennial.

Advisory Board

Chairperson

Arthur I. Jacknowitz,

PharmD

Professor and Arthur I. Jacknowitz

Chair in Clinical Pharmacy

School of Pharmacy

West Virginia University

Morgantown, West Virginia

Deborah Stier Carson,

PharmD, BCPS

Professor of Pharmacy Practice

College of Pharmacy

Medical University of South

Carolina

Charleston, South Carolina

Scott F. Nadler, DO, FACSM

Director of Sports Medicine and

Associate Professor

UMDNJ–New Jersey Medical

School

Newark, New Jersey

Greta M. Pelegrin, PharmD

Assistant Pharmacy Manager

Publix Pharmacy

Miami, Florida

© 2001 by the American Pharmaceutical Association.

All rights reserved. Printed in U.S.A.

IntroductionMusculoskeletal Injuries and Disorders

Musculoskeletal injuries include muscle strains, ligamentsprains, bursitis, and tendinitis. These injuries often are the result ofsports activities (especially overuse or overexertion) or certain occu-pational activities in which repetitive motions are required. Muscle,back, and joint pains were among the most common complaintsreported by respondents to a survey about health problems in the pre-ceding 6 months.1

Arthritis. Osteoarthritis, the most common form of arthri-tis, affects an estimated 21 million Americans.2,3 Risk factors forosteoarthritis include advanced age, female sex, heredity, obesity,and joint trauma or excessive use.2,4,5 More than 7 million physi-cian visits are attributed to osteoarthritis every year.3 The annualdirect and indirect costs (i.e., direct medical expenses and lostwages and productivity) of osteoarthritis and other musculoskele-tal conditions amount to nearly $65 billion in the United States.3

Low Back Pain. Low back pain (from a musculoskeletalinjury or disorder) is particularly common. The annual preva-lence is 15% to 20%, and 70% of Americans have experienced lowback pain at some time during their lifetimes.6,7 Low back painis most common in the group between the ages of 45 and 60 years,although it can occur in younger and older people.8 Risk factorsinclude a sedentary lifestyle, poor posture, and excessive bodyweight.9 The indirect costs due to time lost from work and reducedproductivity are substantial. The estimated annual cost of low backpain in the United States is $38 to $50 billion.6 One third of all dis-ability costs in the United States are attributed to low back pain.8

DysmenorrheaEstimates of the prevalence of dysmenorrhea vary from 30%

to as high as 90% of reproductive-age women because of differ-ences in how the term is defined (generally, pain must be severeenough to limit usual activities or to require medical interven-tion).10-13 The prevalence of dysmenorrhea is higher in adolescentwomen than in older women of childbearing age.10 Risk factorsfor severe dysmenorrhea include early age at menarche, longmenstrual periods, smoking, obesity, alcohol consumption, andlow income.11,12,14 Childbearing has been associated with a reduc-tion in dysmenorrhea, although the evidence is conflicting.11

Dysmenorrhea is a common cause of absenteeism fromschool and the workplace and adversely affects quality of life andgeneral well-being.13 Every year more than $3 billion in lost pro-ductivity is attributed to dysmenorrhea.10

Dysmenorrhea may be primary (i.e., idiopathic with noorganic cause) or secondary to a pathologic process (e.g.,endometriosis, pelvic inflammatory disease).13 Dysmenorrheathat occurs during the first one or two menstrual cycles aftermenarche, begins after the age of 25, or shows little or no response

to nonsteroidal anti-inflammatory drugs (NSAIDs), oral contra-ceptives, or both suggests secondary dysmenorrhea.11 Thetreatment of secondary dysmenorrhea is beyond the scope of thisBulletin because it depends on the cause.

PathophysiologyNociceptors (pain receptors) are free nerve endings located in

skin, muscle, and the viscera.15,16 They may be stimulated bymechanical, thermal, or various chemical stimuli (e.g.,bradykinin, serotonin, potassium ions, histamine) that arereleased by damaged tissues.15,16 Tissue injury also can cause therelease of prostaglandins and substance P, which increase the sen-sitivity of but do not directly stimulate nociceptors.16 Pain duringischemia (reduced blood flow) has been attributed to anaerobicmetabolism and accumulation of lactic acid in tissues.16 Lactic

New Product Bulletin on ThermaCare Therapeutic HeatWraps 1

Learning Objectives

After reading this article, the pharmacist should be able to:

1. Explain the prevalence, epidemiology, and pathophysiologyof pain from musculoskeletal injuries and disorders and primary dysmenorrhea.

2. Discuss the nondrug and nonprescription drug therapyoptions for self-treatment of pain from musculoskeletalinjuries and disorders and primary dysmenorrhea.

3. Describe the appropriate use of ThermaCare TherapeuticHeatWraps in the management of pain from musculoskele-tal injuries and disorders and primary dysmenorrhea,including mechanism of action, administration, efficacy,adverse effects, cautions, drug interactions, and safety.

4. Provide patient counseling and monitor therapeuticresponse to ThermaCare Therapeutic HeatWraps.

5. Answer questions commonly asked by patients about painfrom musculoskeletal injuries and disorders and primarydysmenorrhea and the use of ThermaCare TherapeuticHeatWraps.

acid and possibly bradykinin formed in ischemic tissues stimu-

late nociceptors. Muscle spasm is thought to cause pain both by

mechanically stimulating nociceptors and by constricting blood

vessels, resulting in ischemia.16

Pain signals are transmitted to the central nervous system

through dual peripheral nerve pathways involving (1) fast, myeli-

nated type A-delta fibers and (2) slower, unmyelinated type C fibers

(Figure 1).9,15,16 Fast, sharp, well localized pain signals are trans-

mitted along myelinated type A-delta fibers and are elicited by

mechanical or thermal stimuli. These signals serve the purpose

of alerting and prompting the person to take immediate action to

eliminate the stimulus (e.g., contact with a hot stove). By contrast,

slow, chronic pain signals are transmitted along unmyelinated

type C fibers, and most are elicited by chemical stimuli (and some-

times persistent mechanical or thermal stimuli). Slow, chronic

pain signals (burning, dull aching) tend to increase over time.16

The perception of pain is modulated by inhibitory pathways

descending from the thalamus and brainstem. According to the

gate-control theory, transmission of afferent pain signals from

the periphery to the spinal cord and brain may be modulated by

mildly stimulating type A-delta fibers, which reduces the trans-

mission of pain signals by type C fibers.9

Musculoskeletal PainInjury causes the release from tissues of various chemical

mediators that stimulate nociceptors and cause inflammation.7

The release of leukotrienes (inflammatory mediators) and therecruitment and degranulation of mast cells ensue, resulting inhistamine release, increased vascular permeability, and edema.9

Edematous tissues may compress nerves, causing pain.9

Acute muscle pain during and immediately after intensephysical activity often is the result of ischemia (i.e., inadequateblood supply to the muscle).7 Pain signals originating at aninjured muscle may cause reflex contraction, which worsens thepain.9

Joint pain in the absence of arthritis usually is caused bymechanical or chemical stimuli from minor injury or overexer-tion.7 Joint pain in patients with osteoarthritis may be due todisease-related joint instability and activation of mechanical noci-ceptors during physical activity.4,17 Synovitis, bursitis, andtendinitis also can cause pain. However, inflammation is thoughtto play only a minor role in osteoarthritis (the pathogenesis ofosteoarthritis appears to be multifactorial, involving mechanicalstress, aging, genetics, and other factors).18 Joint pain in patientswith osteoarthritis also may be the result of muscle spasm.4

DysmenorrheaPrimary dysmenorrhea is the result of excessive uterine con-

tractions and ischemia, although its pathogenesis is notcompletely understood.10,13 During the 24 hours preceding theonset of menstruation, endometrial blood vessels becomevasospastic, thereby decreasing the blood supply to theendometrium and causing necrosis of the endometrial lining.19

Contraction of the myometrium (uterine muscle) promotes expul-sion of necrotic endometrial tissue and blood (i.e., menstrualflow). The resting tone of the myometrium, the pressures duringmyometrial contraction, and the frequency of uterine contractionsare increased in women who have dysmenorrhea compared withwomen who do not have dysmenorrhea.10 Myometrial contractionhas been attributed to prostaglandins or other substances.13

Excessive prostaglandins have been implicated in dysmenor-rhea.10,11,13 High levels of prostaglandins are found in themenstrual fluid of patients with dysmenorrhea (especially duringthe first 2 days of menses when symptoms are most severe).11

Administration of prostaglandin synthesis inhibitors (e.g., NSAIDs)often alleviates dysmenorrhea.10 However, some women with pri-mary dysmenorrhea do not have elevated prostaglandin levels anddo not respond to prostaglandin synthesis inhibitors.10 Theories toexplain the pathogenesis of dysmenorrhea in these patients includeexcessive leukotrienes, vasopressin, or both (leukotrienes and vaso-pressin are vasoconstrictors that cause myometrialcontraction).10,11,13 Leukotrienes and prostaglandins both are

2 American Pharmaceutical Association

Figure 1.

Afferent “Pain” Fiber Input Into theSpinal Cord

Source: Adapted and reprinted with permission from Hospital Formulary,Vol. 20 (September 1985), page 973. Copyright ©2001 AdvanstarCommunications Inc. Advanstar Communications Inc. retains all rights tothis material.

Descendingtracts Dorsal horn

Spinothalamic(ascending)tract

Dorsal rootganglion

Spinalnerve

Nociceptoraxons

MyelinatedA-delta fiber

Freenerveending

UnmyelinatedC fiber

Ventral root

formed from arachidonic acid through separate metabolic path-ways (the formation of prostaglandins and leukotrienes is catalyzedby cyclooxygenase and lipoxygenase enzymes, respectively).

Clinical PresentationPatients with acute strains and sprains typically present with

pain, swelling, bruising, decreased function, and gradual stiffen-ing.9 Patients with acute tendinitis or bursitis may present withpain, tenderness, and, because of inflammation, warmth, edema,and redness.9 Patients with injuries caused by repetitive motionmay report paresthesias, numbness, and an unusual sensitivity tostimuli that ordinarily are not painful (e.g., a cool breeze).9

Patients with low back pain often have pain and tightness in thelower back and impaired mobility.9

The primary symptom of osteoarthritis is a chronic deep,localized ache of the weight-bearing joints (e.g., knees, hips, feet,lower back) and the hand joints.4,20 It is relieved by rest andaggravated by activity.4 Patients often experience short-term stiff-ness (up to 30 minutes) of the affected joint after sleeping orperiods of inactivity, and loss of range of motion.4,20

Dysmenorrhea usually presents as dull aching or cramping,with intermittent pain spasms centered at the midline of the lowerabdomen in the suprapubic area.11 The discomfort is cyclic,beginning a few hours or days before the onset of menses and ismost severe during the first day or two of the menstrual period,when the menstrual flow is heaviest.11,13 Dysmenorrhea typicallylasts 48 to 72 hours.10

Self-TreatmentPain from musculoskeletal injuries and disorders and pri-

mary dysmenorrhea often may be self-treated using variousnonprescription drug therapies and nondrug interventions.Exclusion criteria for self-treatment of musculoskeletal pain arelisted in Table 1. Patients rating their pain 6 or higher on anumerical scale from zero for no pain to 10 for the worst painimaginable should consult a physician.7 Although patients withminor arthritis pain (and a diagnosis of arthritis by a physician)may self-treat the pain, patients with symptoms suggestive ofarthritis that is yet to be diagnosed should undergo a diagnosticevaluation by a physician.7 Sharp pain, burning, prickling, ornumbness along a nerve (i.e., neuropathic pain) also should beevaluated by a physician.7

Nonprescription Drug TherapiesMild or moderate musculoskeletal pain (i.e., pain rated 1 to

5 on a scale from zero for no pain to 10 for the most severe pain)often may be managed by using an oral nonprescription NSAID

(aspirin, another salicylate, or a nonsalicylate NSAID, such asibuprofen, ketoprofen, or naproxen sodium) or acetaminophen(Table 2).21 These simple analgesics may be used for self-medication for the temporary relief of muscular aches, backache,and the minor pain of arthritis.21

The efficacy of acetaminophen is comparable to that ofaspirin for relieving mild to moderate pain.7,21 However, aceta-minophen is less effective than ibuprofen for relievinginflammatory pain.7 Nevertheless, acetaminophen is comparablein efficacy to NSAIDs for treating mild to moderate osteoarthritispain, probably because little or no inflammation is present.23

Therefore, acetaminophen is the drug of first choice in treatingosteoarthritis pain.24 If acetaminophen is inadequate for relievingosteoarthritis pain, an oral NSAID may be used instead.

Nonsalicylate NSAIDs (i.e., ibuprofen, ketoprofen, or naproxensodium) are the preferred simple analgesics for primary dysmenor-rhea.10 Nonsalicylate NSAIDs are more effective for treatingdysmenorrhea than are salicylates and acetaminophen, althoughit is sometimes necessary to exceed the nonprescription dosage torelieve dysmenorrhea.10 Therapy for dysmenorrhea should beginat the onset of pain (if there is a possibility of pregnancy, therapyshould not begin until the onset of menses) and be given on ascheduled basis during the first 48 to 72 hours of menstrual flow, not


Table 1.

Exclusion Criteria for Self-Treatment ofMusculoskeletal Paina

• Pain that persists or worsens after 10 days in an adult or 5days in a child despite treatment (except for minor diagnosedarthritis pain)

• Pregnancy or breast-feeding• Age ≤ 7 years• Severe nausea and vomiting, a high fever, or other signs of a

serious infection• Weakness in a limb• Pain in a red, warm, or swollen joint (except for minor

diagnosed arthritis pain)• A suspected fracture• Severe pain or an increase in pain intensity or change in

character• Back pain that is severe, worsens or fails to improve with

rest, or is accompanied by any one of the following:—Fever—History of back injury, corticosteroid use, or cancer—Unexplained weight loss—Bladder or bowel incontinence or urinary retention—Leg weakness—Pain that shoots down the leg beyond the knee

aPatients meeting any of the criteria listed in this table should not self-treat their pain; they

should consult a physician.

Source: References 7–9.


Table 2.

Nonprescription Analgesic Drug Dosages for Self-Medicationa

Drug (Brand Names) Adult Nonprescription Dosageb,c

Acetaminophen (Tylenol, others) Mild to moderate pain in adults and children age >11 yr: 325–650 mg every 4–6 hr as needed, notto exceed 4 g/day

Arthritis pain in adults and children age 12 yr and older: 500–1000 mg every 4–6 hr as needed OR1300 mg as extended-release tablets every 8 hr as needed, not to exceed 4 g/day

Salicylatesd

Aspirin (various brands) Mild to moderate pain or minor arthritis pain in adults and children age >11 yrd: 325–650 mg every4 hr as needed OR 650–1300 mg as extended-release tablets every 8 hr as needed, not to exceed 4 g/day

Choline salicylate (Arthropan) Mild to moderate pain in adults and children age >11 yrd: 435–870 mg (2.5–5 mL of 174-mg/mLsolution) every 4 hr as needed

Mild to moderate pain in children ages 2–11 yrd: 2 g (11.5 mL) per square meter daily in 4–6 divideddoses as needed

Minor arthritis paind: 4.8–7.2 g/day in divided doses in adults and 107–134 mg/kg/day in divideddoses in children as needed

Magnesium salicylate Mild to moderate pain in adults and children age >11 yrd: 300–600 mg every 4 hr as needed OR (Doan’s, others) 500–1000 mg initially, then 500 mg every 4 hr as needed, not to exceed 3.5 g/day

Minor arthritis pain in adults: 545–1200 mg three or four times daily

Nonsalicylate NSAIDs

Ibuprofen Mild to moderate pain, minor arthritis pain, or dysmenorrheae in adults and children age 12 yr and (Advil, Motrin IB, Nuprin, others) older: 200 mg every 4–6 hr as needed initially; may increase to 400 mg every 4–6 hr as needed, not

to exceed 1.2 g/day

Ketoprofen (Actron, Orudis KT) Mild to moderate pain, minor arthritis pain, or dysmenorrheae in adults and adolescents age 16 yr andolder: 12.5 mg every 4–6 hr (may give additional 12.5 mg if no response within 1 hr after a givendose), not to exceed 25 mg in 4-hr period or 75 mg in 24-hr period

Naproxen sodiumf (Aleve) Mild to moderate pain, minor arthritis pain, or dysmenorrheae in adults age ≤ 65 yr: 220 mg every8–12 hr (or 440 mg followed by 220 mg 12 hr later) as needed, not to exceed 660 mg/day

Mild to moderate pain, minor arthritis pain, or dysmenorrhea in adults age >65 yr: 220 mg every 12 hr as needed

NSAIDs = nonsteroidal antiinflammatory drugsa All therapies are oral.

b The nonprescription dosages listed for treating minor arthritis pain may be lower than those recommended for prescription use by patients under a physician’s care.

c Self-medication for pain should not exceed 10 days in adults or 5 days in children (3 days in children receiving ibuprofen), unless under a physician’s care. To minimize the risk of overdosage, no more than

five doses should be given to a child in a 24-hour period.

d Aspirin and other salicylates should not be given to children or teenagers with chickenpox or flu symptoms because of the risk of Reye’s syndrome.

e Therapy for dysmenorrhea should be on a scheduled basis during the first 48–72 hours of menstrual flow, not on an “as needed” basis. Dosages larger than the nonprescription ones listed in this table may

be required to provide relief.

f Each naproxen sodium 220-mg tablet is equivalent to naproxen 200 mg.

Source: References 10, 21, and 22.

on an “as needed” basis.10 Prophylactic therapy before the onsetof menstrual pain is not recommended.10 If the response to a non-salicylate NSAID is inadequate, another agent in this drug classshould be tried because it may be more effective.10

NSAIDs. The nonprescription NSAIDs include aspirin, thesalicylate salts (e.g., choline salicylate, magnesium salicylate),and the nonsalicylate NSAIDs ibuprofen, ketoprofen, andnaproxen sodium. These agents all have analgesic and anti-inflammatory properties, although the anti-inflammatory activitygenerally occurs only at dosages higher than those used withouta prescription.7,21 NSAIDs inhibit the synthesis of prostaglandins,which appear to sensitize pain receptors to mechanical stimulationand other chemical mediators.21 Analgesia is primarily the resultof peripheral activity.21 NSAIDs inhibit the cyclooxygenaseenzymes involved in prostaglandin synthesis from arachidonicacid but they do not inhibit the lipoxygenase enzyme involved inthe formation of leukotrienes from arachidonic acid.21

Reye’s syndrome, a potentially fatal condition characterizedby recurrent vomiting and coma, has been linked to the use ofsalicylates (primarily aspirin) by children and adolescents withvaricella or influenza.21 Therefore aspirin and other salicylatesshould not be given to children or teenagers with chickenpox orflu-like symptoms.

The most common adverse effects from NSAIDs involve thegastrointestinal (GI) tract.21 Erosion or ulceration of the GImucosa and bleeding can occur. NSAID-induced GI toxicity isresponsible for more than 100,000 hospitalizations and 16,500deaths each year in the United States.25 These effects may be lesslikely with the salicylate salts than with aspirin and other nonsal-icylate NSAIDs (e.g., ibuprofen) because aspirin and nonsalicylateNSAIDs inhibit platelet aggregation and prolong bleeding time.21

NSAIDs should be avoided in patients with a history of peptic ulcerdisease or GI bleeding and patients who are receiving anticoagu-lant drug therapy. Aspirin is contraindicated in patients withbleeding disorders. Patients who consume three or more alcoholicbeverages daily should use NSAIDs only while under the care of aphysician because alcohol increases the risk and severity of GIbleeding and ulceration from these drugs.21

Sensitivity reactions to aspirin that manifest primarily asbronchospasm occur rarely, often in patients with asthma andnasal polyps (the aspirin triad).21 NSAIDs should not be used inpatients with aspirin sensitivity because such patients often arecross-sensitive to other NSAIDs.

NSAIDs should be used with caution in patients withimpaired renal function because inhibition of renalprostaglandins by these agents may result in deterioration in renalfunction and overt renal decompensation or acute tubular necro-sis with renal failure.21 NSAIDs also should be used cautiously inpatients with heart failure, hypertension, or other conditions asso-ciated with fluid retention and edema.21

Acetaminophen. Acetaminophen is an analgesic agentthat has little or no anti-inflammatory activity.21 Its mechanismof action is similar to that of the NSAIDs (i.e., inhibition ofprostaglandin synthesis) but acetaminophen acts centrally ratherthan peripherally.21

Acetaminophen is relatively safe at therapeutic dosages. It isless likely than NSAIDs to cause GI ulcers or bleeding.21

Acetaminophen should be used with caution in patients withhepatic disease, although it rarely causes hepatotoxicity at thera-peutic dosages.24 Hepatotoxicity may be the result of inadvertentoverdosage in patients using multiple nonprescription drug prod-ucts that contain acetaminophen.26,27 Chronic heavy alcoholabuse may increase the risk of hepatotoxicity from excessive aceta-minophen dosages.21 Therefore, patients who regularly consumethree or more alcohol-containing drinks daily should consult theirphysicians before using acetaminophen and be advised not toexceed the recommended dosage.

Glucosamine and Chondroitin. The dietary supple-ments glucosamine sulfate (a naturally occurring substrate for thesynthesis of cartilage) and chondroitin sulfate (a component ofcartilage) have been used alone and in combination to relieveosteoarthritis pain.28 A meta-analysis of clinical trials that usedglucosamine and chondroitin for osteoarthritis symptoms demon-strated a moderate to large treatment effect, although the effectmay have been exaggerated because of methodologic flaws (e.g.,small number of patients) and publication bias.29

Adverse effects from glucosamine and chondroitin are mildand affect the GI tract (e.g., intestinal gas and soft stools fromchondroitin).2,30

Topical Therapies. Topical counterirritants may beapplied to a painful area to alleviate minor muscle and joint achesand pain (e.g., strains, sprains, backache, minor arthritis pain).9

They are formulated as liniments, gels, creams, lotions, and oint-ments.9 The counterirritants are a heterogeneous group withvarious proposed mechanisms of action. The analgesia producedby some counterirritants may be explained in part by the gate-control theory (see the Pathophysiology section).9 Some agents(e.g., camphor, menthol) decrease the response of sensory recep-tors in the skin to painful stimuli. Others are thought to stimulatesensory nerve endings in the skin and cause reflex peripheralvasodilation, which results in a sensation of warmth. The nature ofthe effect from counterirritants may depend on the concentrationused and the duration of contact with the skin.9 The massagingaction involved in applying a topical counterirritant product maycontribute to analgesia.9

Capsaicin is derived from hot chili peppers.9 It reduces jointpain by depleting substance P in local sensory nerve endings andtype C fibers.4 Topical capsaicin (a cream available without aprescription) is effective for relieving osteoarthritis pain.31,32 It isapplied four times daily and often must be used continuously for


at least 1 to 2 weeks before pain relief begins (the time to onset ofrelief of other types of pain may be longer).9,24 Capsaicin causesan initial local burning sensation that usually decreases within72 hours with continued use.9

Topical agents should not be applied to broken skin orallowed to come in contact with the eyes or mucous membranes.They should not be used with occlusive dressings, heating pads,or other heating devices or after strenuous exercise in hot, humidweather because of the risk of increased percutaneous absorptionand toxicity.9

Nondrug InterventionsLifestyle modification (e.g. smoking cessation, avoidance of

alcohol, reduction in dietary fat intake) may be helpful for womenwith dysmenorrhea.10,33 Patients with arthritis or low back painmay benefit from weight loss. Massage may relieve pain by pro-ducing counterirritation, increasing local blood flow, andreducing stress.9

Ice. Rest, ice, compression, and elevation—a regimenreferred to as RICE—is recommended initially for sprains, strains,and other acute injuries.9 Cold provides local analgesia andreduces inflammation and muscle spasm after an injury.34

Analgesia may be the result of altered neurotransmission or bloodflow, endorphin production, or decreased muscle spasm.34 Coldalso is effective for treating minor arthritis pain, although heat isoften preferred for chronic arthritis pain.2

Ice should be applied (wrapped in a towel or other cloth) assoon as possible after an injury.2 It should be reapplied for nomore than 20 minutes (to prevent ice burns) three or four times aday for 1 to 2 days after the injury.9

Heat. Heat causes vasodilation and increases local bloodflow.9,35 It may provide local analgesia (possibly through coun-terirritation and an effect on gate-controlled pain), promotehealing, relax muscles, reduce muscle spasm and stiffness, andincrease the flexibility and range of motion of muscles andjoints.2,7,9,34 Heat often facilitates exercise in patients with arthri-tis.2,36 Women with primary dysmenorrhea may obtain relief byapplying heat to the lower back or abdomen.10

Heat may be applied using a hot shower or bath, heat lamp,hot water bottle, electric heating pad, moist steam pack, warmparaffin wax, or heat wrap (ThermaCare Therapeutic HeatWrapsare described later in this New Product Bulletin).2,9 Heat shouldnot be applied for at least 48 hours after an injury has occurredor if swelling is present (ice is preferred to reduce inflammation).9

Heat treatments can cause burns, especially if the patient issedated or if sensation or circulation is impaired.37 Heat gener-ally should not be applied for more than 15 to 20 minutes at atime (ThermaCare Therapeutic HeatWraps are an exceptionbecause they produce low-level heat that is safe for much longerperiods).2,38 Patients should be advised not to lie on top of a heat-

ing pad or use it while sleeping (ThermaCare TherapeuticHeatWraps are an exception) because the circulation of blood tothe area may be slowed, increasing the risk of a burn.37 Heatshould not be used in conjunction with topical preparations (espe-cially counterirritants) because it may increase percutaneousabsorption and the potential for toxicity.9

Exercise. Although rest is part of the RICE therapy recom-mended for the first few days after acute musculoskeletal injury,careful exercise after this initial rest period is part of the recoveryprocess for muscles injured by overexertion. In the past, bed restwas recommended for patients with low back pain.6 An earlyreturn to normal activities (within the limits permitted by pain)now is recommended because it results in a faster return to work,less chronic disability, and fewer recurrent problems.39-41

In patients with arthritis, exercise reduces joint pain andstiffness and increases flexibility, range of motion, musclestrength, and functional ability.24,36 Exercise is widely thought toameliorate primary dysmenorrhea, although the evidence is con-flicting.10,42 Theories for the mechanism by which exercise mightalleviate dysmenorrhea include improved pelvic blood flow, weightloss, and release of endorphins.42

ThermaCare®

Therapeutic HeatWrapsDescription

ThermaCare Therapeutic HeatWraps are portable, air-activated, disposable (i.e., single use), self-heating medical devicesdesigned to provide continuous low-level therapeutic heat (104° For 40° C) for up to 8 hours.38,43 They are available without a pre-scription. The wraps have a thin, flexible design that allows themto be worn comfortably and discreetly beneath clothing. Thereare three products with different shapes for use at various bodysites. All products allow the patient to remain mobile while wear-ing them. Back wraps are worn around the waist and are availablein two sizes. Neck-to-arm wraps may be used on the neck andshoulder (e.g., the trapezius muscle), a wrist, or various other sites(i.e., the shape accommodates many different body parts). Theneck-to-arm wraps have an adhesive on the skin surface side thatkeeps the wrap in place. Menstrual wraps are kidney bean-shapedand fit on the lower abdomen. They have an adhesive on the out-side surface that allows them to adhere to the inside of thepanties.38

Each wrap has a heat pack area composed of oval heat discsthat contain a mixture of natural heat-generating materials,including iron, carbon, sodium chloride, sodium thiosulfate, andwater.38 When the iron in these heat cells is exposed to air, itundergoes an exothermic oxidative reaction. The carbon and


sodium salts accelerate the process. A perforated film with limitedoxygen permeability regulates heat production.38

Approved IndicationsThermaCare Therapeutic HeatWraps are indicated for the

temporary relief of minor muscular and joint aches and pain asso-ciated with overexertion, strains, sprains, and arthritis.38 They alsoare indicated for the temporary relief of minor menstrual cramp-ing pain and associated backache.

AdministrationBecause ThermaCare Therapeutic HeatWraps are activated

by air, the air-tight pouch should be opened only when the patientis ready to use a wrap.38 It may take up to 30 minutes for a thera-peutic temperature to be achieved. If the wrap does not seemsufficiently warm after 30 minutes, it should be taken off andfolded up for a few minutes before putting it back on. At least 3hours of wear is recommended, although wearing ThermaCarewraps for a full 8 hours is suggested for maximum effectiveness.Two or three consecutive days of use are recommended for sus-tained and enhanced benefits. However, the wraps should not beworn for more than 8 hours in a 24-hour period or 7 consecutivedays (4 days for dysmenorrhea).38

EfficacyLow Back Pain. A randomized, controlled, single-blind,

pilot study was conducted to evaluate the efficacy of ThermaCareTherapeutic HeatWraps in 81 adults with acute muscular low backpain of moderate or more severe intensity.44 Patients were ran-domized to wear one of three wraps (36° C, 38° C, and unheated)for 8 hours/day and take acetaminophen 650 mg, placebo, or nomedication orally three times daily for 3 consecutive days. Theheated wraps provided significantly greater pain relief than theunheated wrap and this effect was maintained for 24 hours afterremoving the wraps. The groups using heated wraps and receiv-ing acetaminophen had significantly greater pain relief over the3-day treatment period than did the group using unheated wrapsand receiving acetaminophen (i.e., the effect of the heat wraps wasadditive with that of acetaminophen).44

ThermaCare Therapeutic HeatWraps (worn for approxi-mately 8 hours/day for 3 consecutive days) produced significantlygreater pain relief, reduction in muscle stiffness, and increase inlateral trunk range of motion (ability to bend sideways) than anoral placebo (taken three times daily) in a multicenter, random-ized, single-blind, placebo-controlled study of 219 adults withacute nonspecific low back pain of at least moderate intensity.38

The differences were significant on days 4 and 5 (i.e., after dis-continuing wrap wear and the oral placebo) as well as during the3-day treatment period. Disability on day 3 and day 5 (the only

days on which it was assessed) was significantly lower in the heatwrap group than in the oral placebo group.38

The efficacy and safety of overnight use of ThermaCareTherapeutic HeatWraps (worn 8 hours/night for 3 consecutivenights) were assessed in a randomized, controlled, single-blindstudy of 76 adults with acute muscular low back pain of moder-ate or more severe intensity.45 The HeatWraps provided significantincreases in morning pain relief and trunk range of motion anddecreases in muscle stiffness and disability compared with an oralplacebo taken nightly. The therapeutic effects of heat therapy wereobserved during both the 3-day treatment period and a 2-day follow-up period. Subjective sleep quality was improved and sleeponset difficulty was reduced by heat therapy.45

In a randomized, controlled, multicenter, single-blind studyof 371 subjects with acute, nonspecific low back pain, ThermaCareTherapeutic HeatWraps (worn 8 hours/day for 2 days) providedgreater pain relief, improvement in lateral trunk flexibility, andreduction in muscle stiffness and disability than either aceta-minophen (4 g/day) or ibuprofen (1.2 g/day).46

Other Musculoskeletal Pain. The efficacy ofThermaCare neck-to-arm wraps in treating neck and shoulderpain was assessed in 92 adults with moderate or more severetrapezius muscle pain in a randomized, controlled, multicenter,single-blind study.47 The heated wrap (worn approximately 8hours/day) plus an oral placebo produced significantly greaterpain relief and significantly less muscle tension over a 3-day treat-ment period than an unheated wrap plus placebo. Pain relief wassignificantly greater and muscle tension was significantly less withthe heated wrap plus ibuprofen (400 mg three times daily for 3days) than with no wrap plus ibuprofen. Pain relief persisted for 3days after removing the heated wrap.47

A randomized, multicenter, single-blind study ofThermaCare Therapeutic HeatWraps was conducted in 90 adultswith wrist pain from osteoarthritis, a strain, or a sprain.38 TheHeatWraps (worn 8 hours/day for 3 consecutive days) producedsignificantly greater pain relief than an oral placebo. They alsosignificantly improved grip strength.38

Dysmenorrhea. The efficacy of ThermaCare TherapeuticHeatWraps in treating dysmenorrhea was evaluated in a random-ized, placebo-controlled study of 81 women (21–50 years of age)with moderate or more severe dysmenorrhea.48 Subjects were ran-domized to wear a ThermaCare menstrual HeatWrap or anunheated wrap for approximately 12 consecutive hours daily (i.e.,4 hours longer than is currently recommended) and take ibupro-fen 400 mg or placebo orally three times daily for 2 consecutivedays. Pain relief was similar with the heated wrap plus placebo, theheated wrap plus ibuprofen, and the unheated wrap plus ibupro-fen, and relief was significantly greater than that in the unheatedwrap plus placebo group. The time to onset of noticeable painrelief was significantly shorter for patients in the heated wrap plus


ibuprofen group (median 1.5 hours) than in patients in theunheated wrap plus ibuprofen group (median 2.8 hours).48

Compared with the unheated wrap plus placebo, the reduction inoverall symptom severity score (as a quality-of-life assessment)was significantly greater with the heated wrap plus placebo but thereduction was not significantly different with the unheated wrapplus ibuprofen or the heated wrap plus ibuprofen.48

Abdominal muscle tightness (patient self-ratings), durationof treatment effectiveness (the primary end point), and overallsymptom severity (part of a quality-of-life assessment) were eval-uated in addition to pain relief in a multicenter, randomized,single-blind study of 147 adult women with primary dysmenor-rhea.38 Pain relief from a heated menstrual wrap (worn forapproximately 8 hours on a single day) was significantly greaterthan that from placebo and comparable to that from a single oral400-mg dose of ibuprofen. The median duration of treatmenteffectiveness was 11.0 hours with the heated wrap and 7.8 hourswith ibuprofen, a difference that is not significant. The heatedwrap produced significantly less abdominal muscle tightness thanplacebo. The heated wrap was associated with a significantdecrease in overall symptom severity (as well as improvements inanger, anxiety, depression, mood, fatigue, headaches, aches, back-ache, cramping, appetite, cravings, and insomnia) compared with

placebo.38 There was no significant difference between the heatedwrap and ibuprofen with respect to abdominal muscle tightnessor overall symptom severity.

(Additional information about ThermaCare Therapeutic HeatWrapswill be posted on the APhA Web site at http://www.aphanet.org.)

Adverse EventsThe safety of ThermaCare Therapeutic HeatWraps has been

thoroughly studied.38 Two studies of daytime wear and two stud-ies of nighttime wear were conducted. These studies were designedto maximize the likelihood of observing adverse skin effects by(1) recruiting subjects expected to be at high risk because ofadvanced age, (2) requesting wear times at the upper limit of whatis recommended or use on many consecutive days or nights, and(3) recording daily skin evaluations made by trained observers.Subjects wore ThermaCare wraps continuously for 8 hours oneach of 4 consecutive days (the menstrual product), 8 consecu-tive days (the back product), or 8 consecutive nights (the back andneck-to-arm products). Twelve (5%) of 228 subjects discontinuedusing ThermaCare wraps because of adverse skin effects. Twentyeight percent of subjects experienced slight or mild erythema, andanother 4% experienced more than mild (i.e., moderate or severe)


What It Is: Disposable, air-activated, self-heating wrap

How It Works: Delivers consistent low-level heat as a result of an exothermic reaction

What It Does: Relieves pain, reduces muscle stiffness, increases lateral trunk flexibility and range of motion, andreduces disability in patients with muscular low back pain; relieves pain and reduces muscle tension inpatients with neck and shoulder muscle pain; relieves wrist pain and improves grip strength; andrelieves menstrual cramping pain and backache

Indications: Temporary relief of minor muscular and joint aches and pain associated with overexertion, strains,sprains, and arthritis; and relieves minor menstrual cramping pain and associated backache

How Supplied: Back wraps in two waist sizes, menstrual wraps, and neck-to-arm wraps for use on upper back, shoul-der, wrist, or other sites

Dosage: Use for up to 8 hours/day and 7 consecutive days (4 days for dysmenorrhea)

Most Common Adverse Event: Skin redness

Drug Interactions: Medicated lotions, creams, and ointments; estrogen skin patches and other transdermal medicationsystems

Use in Pregnancy: Use on abdomen is not recommended unless under a physician’s care

ThermaCare® Therapeutic HeatWraps at a Glance

erythema. The other 68% of subjects had no erythema. In the samesafety studies, an elevated skin response was observed in 16% ofsubjects, including papules in 7%, edema in 4%, miliaria (inflam-mation of the sweat glands) in 3%, a follicular response in 2%,vesicles in fewer than 1%, and bullae in fewer than 1%. Theseeffects were limited to the site of application of the wraps. None ofthe events (other than erythema) was severe, and all resolved with-out medical intervention.38

In the overnight use study of 76 patients with low back paindescribed in the Efficacy section, five subjects (15%) in theThermaCare group exhibited faint pinkness of the skin.45 Itresolved without treatment or withdrawal from the study.

The skin adhesive used in the neck-to-arm wraps was evalu-ated for skin irritation and sensitization potential.38 The adhesivewas well tolerated when tested under occlusive patches in 21 sub-jects in a 21-day cumulative irritation study. In most cases,irritation associated with the skin adhesive was mild and reversiblewithout medical intervention.38

CautionsThermaCare Therapeutic HeatWraps should be used with

caution by patients with diabetes mellitus or other disorders char-acterized by poor circulation, decreased ability to sense heat, orskin that is broken or damaged.38 Patients with diabetes mellitusmay be more susceptible to skin irritation and injury than healthypeople because they typically have poor circulation and dimin-ished ability to sense high temperatures. Patients who aresusceptible to skin ulcer formation because they have diabetes orare bedridden should not use ThermaCare wraps. People (espe-cially children) who are unable to follow directions or remove theproduct themselves in the event of discomfort should not useThermaCare wraps.38

Patients with rheumatoid arthritis should consult theirphysicians before using ThermaCare Therapeutic HeatWraps todetermine whether heat therapy will be helpful.43

ThermaCare wraps should not be used on areas with bruisingor swelling within the previous 48 hours because heat may aggra-vate the injury.43 ThermaCare wraps should not be used with otherforms of heat therapy (e.g., electric heating pads).38

Patients should be advised to remove the wrap and checktheir skin for redness and irritation periodically if they know that itis sensitive to heat, feel that their tolerance to heat has dimin-ished over the years, lie down or lean back against the product, orwear a tight-fitting belt or waistband over the product.38 Theelderly may be at increased risk of a reaction if they have impairedcirculation or skin that is particularly sensitive to heat.38 Personswho know that their skin is sensitive to heat should try using

ThermaCare wraps during the daytime before wearing them whilesleeping.38

Slight skin redness is normal.43 However, if it persists formore than a few hours, the wrap should be removed until the red-ness goes away completely. To prevent prolonged redness in thefuture, ThermaCare wraps should be worn for a shorter period,with looser clothing, or over a thin layer of clothing instead ofdirectly against the skin.38 If skin irritation or burning occurs,the wrap should be removed immediately until the irritationresolves and the burn heals completely. If swelling, a rash, or otherskin changes occur at the site where a wrap is worn, the patientshould be advised to stop using the ThermaCare wrap immediatelyand consult a physician if the effect persists.38

Women who are pregnant should not use ThermaCare wrapson their abdomens without consulting their physicians.38

Drug InteractionsThermaCare wraps should not be used in conjunction with

medicated lotions, creams, or ointments because the risk of a skinreaction may be increased.43

ThermaCare wraps should not be worn over an estrogen skinpatch or any other transdermal medication system.43 The effectof the heat from ThermaCare wraps on transdermal absorption ofmedications has not been studied.

SafetyThermaCare wraps should be stored and disposed of out of

the reach of children and pets because they contain iron (approx-imately 2 g in each heat disc), which can be harmful if it isingested.38 In the event of ingestion, the mouth should be rinsedwith water at once and a poison control center should be contactedimmediately. If water is not available, another noncarbonated bev-erage (e.g., milk, fruit juice) may be used, but carbonatedbeverages should not be used to rinse the mouth because they maycause further irritation.38 If the contents of a heat disc come incontact with the skin or eyes, they should be rinsed with waterimmediately.

The heat discs should not be torn or cut. In the unlikely eventthat the material covering a disc is accidentally broken or torn, thewrap should be discarded.

ThermaCare wraps may be disposed of with the householdtrash. The impact of disposal of ThermaCare wraps on the envi-ronment has been extensively evaluated. All raw materials usedin ThermaCare wraps are environmentally compatible.38

To avoid the risk of fire, ThermaCare wraps should not beheated (e.g., using a microwave oven).


Pharmaceutical CareConsiderations

As the most readily accessible health care professional, thepharmacist is frequently asked for advice by patients who havepain from musculoskeletal injuries or menstrual cramps. Thepharmacist might suspect a musculoskeletal injury in a patientwho is purchasing elasticized bandages and nonprescription anal-gesics. The pharmacist should ask about the nature (e.g., stabbingversus dull pain), location, onset, duration, and probable causeof the pain and factors that relieve or aggravate it. The patientshould be asked to rate the severity of the pain on a scale from zerofor no pain to 10 for the most severe pain imaginable, and thepharmacist should refer patients who have pain with a rating of 6or higher to a physician. The exclusion criteria for self-treatmentlisted in Table 1 should be used to determine whether the patient isa candidate for self-treatment. The pharmacist should obtain acomplete patient history, including illnesses, injuries, pregnancy,drug therapies (including the use of complementary and alterna-tive medications), allergies, smoking status, and alcohol use. Pastresponse to analgesics (and oral contraceptives for patients withdysmenorrhea) should be ascertained. Patients with dysmenor-rhea that occurs during the first one or two menstrual cycles aftermenarche, that began after the age of 25, or that has shown littleor no response to NSAIDs, oral contraceptives (oral contraceptivesreduce prostaglandin levels), or both should be referred to a physi-cian.49

The pharmacist should educate patients with musculoskele-tal pain or dysmenorrhea who are suitable candidates forself-treatment about appropriate nondrug interventions and non-prescription drug therapies. The pharmacist should recommendalternatives to oral analgesics for patients who do not wish to takethem or are unable to tolerate them. Patients stand to benefit fromadvice about the role of exercise and heat and cold therapy. Thepharmacist should warn patients about possible adverse effectsfrom nonprescription analgesics and advise patients how to avoidor minimize these effects.

The pharmacist can monitor response to nondrug interven-tions and nonprescription drug therapy (e.g., by telephone or mailfollow-up). Patients should be encouraged to contact a physicianif their pain worsens or does not improve after an adequate trialof self-treatment. Nonprescription analgesic dosages may be inad-equate for reducing pain associated with inflammation.

SummaryPain from musculoskeletal injuries and disorders and pain

from primary dysmenorrhea are common complaints. Pain may becaused by various chemical mediators or ischemia. In many cases,

patients with musculoskeletal pain, minor arthritis pain, or pri-mary dysmenorrhea may safely self-treat their discomfort usingnondrug interventions, nonprescription medications, or both.

ThermaCare Therapeutic HeatWraps are a new convenientform of heat therapy. In patients with acute muscular low backpain, ThermaCare Therapeutic HeatWraps relieve pain, decreasemuscle stiffness, increase lateral trunk flexibility and range ofmotion, and reduce disability. These benefits appear to be greaterthan those achieved with ibuprofen or acetaminophen alone. Painrelief is additive with that of acetaminophen. Nighttime wear ofthe wraps improves sleep quality, reduces sleep onset difficulty, andreduces morning pain and muscle stiffness without undue risk ofadverse skin effects. ThermaCare Therapeutic HeatWraps relievepain and reduce muscle tension in patients with neck and shoul-der muscle pain; these effects are additive with that of ibuprofen.In patients with wrist pain due to osteoarthritis, a sprain, or astrain, ThermaCare Therapeutic HeatWraps relieve pain andimprove grip strength. In women with primary dysmenorrhea,ThermaCare Therapeutic HeatWraps relieve menstrual crampingpain and backache. Pain relief is similar to that provided byibuprofen. However, pain relief occurs more quickly whenThermaCare Therapeutic HeatWraps are used with ibuprofen thanwhen ibuprofen is used alone.

ThermaCare Therapeutic HeatWraps generally are well toler-ated. Skin redness and irritation may occur but adverse skin effectsusually are mild and transient.

Pharmacists can provide a valuable service to patients withmusculoskeletal pain or menstrual cramps by determiningwhether they are suitable candidates for self-treatment and advis-ing them on appropriate nondrug interventions andnonprescription drug therapies. Educating patients on the role ofexercise and heat and cold therapy and on the proper use of non-prescription analgesics can improve patient outcomes.

References1. Consumer Healthcare Products Association. Self-care in the new

millennium: American attitudes toward maintaining personal health and treatment. Available at: http://www.chpa-info.org/pdfs/CHPA%20Final%20Report%20revised%20(03-20)_.pdf. Accessed October 25, 2001.

2. The Arthritis Foundation’s Guide to Good Living with Osteoarthritis.Atlanta, GA: Arthritis Foundation; 2000.

3. Arthritis Foundation. Osteoarthritis (OA). Available at:http://www.arthritis.org/conditions/DiseaseCenter/oa.asp.Accessed October 26, 2001.

4. Brandt KD. Osteoarthritis. In: Braunwald E, Fauci AS, Kasper DL,et al, eds. Harrison’s Principles of Internal Medicine, 15th ed. NewYork, NY: McGraw-Hill Inc; 2001;1987–94.

5. Cooper SM. Improving outcomes in osteoarthritis: how to helppatients stay a step ahead of the pain. Postgrad Med.1999;105:29–32,36–8.

6. Atlas SJ, Deyo RA. Evaluating and managing acute low back painin the primary care setting. J Gen Intern Med. 2001;16:120–31.


7. Lipman AG, Jackson KC II. Headache and muscle and joint pain.In: Handbook of Nonprescription Drugs. 12th ed. Washington, DC:American Pharmaceutical Association; 2000:41–76.

8. Bratton RL. Assessment and management of acute low back pain.Am Fam Physician. 1999;60:2299–308.

9. Jacknowitz AI. Musculoskeletal injuries and disorders. In:Handbook of Nonprescription Drugs. 12th ed. Washington, DC:American Pharmaceutical Association; 2000:89–114.

10. Shimp LA. Disorders related to menstruation. In: Handbook ofNonprescription Drugs. 12th ed. Washington, DC: AmericanPharmaceutical Association; 2000:133–51.

11. Coco AS. Primary dysmenorrhea. Am Fam Physician.1999;60:489–96.

12. Jamieson DJ, Steege JF. The prevalence of dysmenorrhea, dys-pareunia, pelvic pain, and irritable bowel syndrome in primary carepractices. Obstet Gynecol. 1996;87:55–8.

13. Deligeoroglou E. Dysmenorrhea. Ann NY Acad Sci.2000;900:237–44.

14. Harlow SD, Park M. A longitudinal study of risk factors for theoccurrence, duration and severity of menstrual cramps in a cohortof college women. Br J Obstet Gynaecol. 1996;103:1134–42.

15. Taylor EC, Koo PJS. Pain. In: Koda-Kimble MA, Young LY, KradjanWA, et al, eds. Applied Therapeutics: The Clinical Use of Drugs.7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2001:chap7.

16. Guyton AC, Hall JE. Somatic sensations, II: pain, headache, andthermal sensations. In: Textbook of Medical Physiology. 10th ed.Philadelphia, PA: WB Saunders Company; 2000:552–63.

17. Boh LE. Osteoarthritis. In: DiPiro JT, Talbert RL, Yee GC, et al, eds.Pharmacotherapy: A Pathophysiologic Approach. 4th ed.Stamford, CT: Appleton & Lange; 1999:1441–59.

18. Loeser RF. Aging and the etiopathogenesis and treatment ofosteoarthritis. Rheum Dis Clin North Am. 2000;26:547–67.

19. Guyton AC, Hall JE. Female physiology before pregnancy and thefemale hormones. In: Textbook of Medical Physiology. 10th ed.Philadelphia, PA: WB Saunders Company; 2000:929–43.

20. Chen SW, Gong WC. Rheumatic disorders. In: Koda-Kimble MA,Young LY, Kradjan WA, eds. Applied Therapeutics: The ClinicalUse of Drugs. 7th ed. Philadelphia, PA: Lippincott Williams &Wilkins; 2001:chap 41.

21. McEvoy GK, ed. AHFS Drug Information 2001. Bethesda, MD:American Society of Health-System Pharmacists; 2001.

22. Physicians’ Desk Reference for Nonprescription Drugs and DietarySupplements. 22nd ed. Montvale, NJ: Medical EconomicsCompany Inc; 2001.

23. Bradley JD, Brandt KD, Katz BP, et al. Comparison of an anti-inflammatory dose of ibuprofen, an analgesic dose of ibuprofen,and acetaminophen in the treatment of patients with osteoarthri-tis of the knee. N Engl J Med. 1991;325:87–91.

24. American College of Rheumatology Subcommittee onOsteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update.Arthritis Rheum. 2000;43:1905–15.

25. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity ofnonsteroidal antiinflammatory drugs. N Engl J Med.1999;340:1888–99.

26. US Food and Drug Administration Center for Drug Evaluation andResearch. Drug-induced liver toxicity. Available at:http://www.fda.gov/cder/livertox/default.htm. AccessedNovember 8, 2001.

27. Schiodt FV, Rochling FA, Casey DL, et al. Acetaminophen toxicityin an urban county hospital. N Engl J Med. 1997;337:1112–7.

28. Hulisz DT. Safety and efficacy of glucosamine and chondroitin inosteoarthritis. US Pharmacist. 2001;26:40, 42, 46, 48, 51, 52.

29. McAlindon TE, LaValley MP, Gulin JP, et al. Glucosamine andchondroitin for treatment of osteoarthritis: a systematic qualityassessment and meta-analysis. JAMA. 2000;283:1469–75.

30. Reginster JY, Gillot V, Bruyere O, et al. Evidence of nutriceuticaleffectiveness in the treatment of osteoarthritis. Curr RheumatolRep. 2000;2:472–7.

31. McCleane G. The analgesic efficacy of topical capsaicin isenhanced by glyceryl trinitrate in painful osteoarthritis: a random-ized, double blind, placebo controlled study. Eur J Pain.2000;4:355–60.

32. Altman RD, Gottlieb NL, Howell D, eds. Neuropeptides, capsaicinand musculoskeletal pain. Semin Arthritis Rheum. 1994;6(suppl3):1–51.

33. Sagraves R, Parent-Stevens L, Hardman J. Gynecologic disorders.In: Koda-Kimble MA, Young LY, Kradjan WA, eds. AppliedTherapeutics: The Clinical Use of Drugs. 7th ed. Philadelphia, PA:Lippincott Williams & Wilkins; 2001:chap 46.

34. Minor MA, Sanford MK. The role of physical therapy and physicalmodalities in pain management. Rheum Dis Clin North Am.1999;25:233–48.

35. Oosterveld FG, Rasker JJ. Treating arthritis with locally appliedheat or cold. Semin Arthritis Rheum. 1994;24:82–90.

36. National Institute of Arthritis and Musculoskeletal and SkinDiseases. Questions and answers about arthritis and exercise.Available at: http://www.nih.gov/niams/healthinfo/arthexfs.htm.Accessed November 16, 2001.

37. Brandt KD. Diagnosis and Nonsurgical Management ofOsteoarthritis. 2nd ed. Caddo, OK: Professional CommunicationsInc; 2000.

38. ThermaCare product monograph. Procter & Gamble; Cincinnati,OH. November 2001.

39. Malmivaara A, Hakkinen U, Aro T, et al. The treatment of acutelow back pain—bed rest, exercises, or ordinary activity? N Engl JMed. 1995;332:351–5.

40. Waddell G, Feder G, Lewis M. Systematic reviews of bed rest andadvice to stay active for acute low back pain. Br J Gen Pract.1997;47:647–52.

41. Biering-Sørensen F, Bendix AF. Working off low back pain. Lancet.2000;355:1929–30.

42. Golomb LM, Solidum AA, Warren MP. Primary dysmenorrhea andphysical activity. Med Sci Sports Exerc. 1998;30:906–9.

43. ThermaCare product information. Available at: http://www. ther-macare.com. Accessed November 16, 2001.

44. Steiner D, Erasala G, Hengehold D, et al. Continuous low-levelheat therapy for acute muscular low back pain. Presented at: 19thAnnual Scientific Meeting of the American Pain Society;November 2–5, 2000; Atlanta, GA.

45. Abeln S, Weingand K, Erasala G, et al. Overnight treatment withcontinuous low-level topical heat therapy provides effective reliefof low back pain [abstract]. J Am Pharm Assoc. 2001;41:307–8.

46. Nadler SF, Steiner DJ, Erasala GN, et al. Continuous low-levelheatwrap therapy provides more efficacy than ibuprofen andacetaminophen for acute low back pain. Spine. In press.

47. Steiner D, Erasala G, Hengehold D, et al. Continuous low-level top-ical heat therapy for trapezius myalgia. Presented at: 19th AnnualScientific Meeting of the American Pain Society; November 2–5,2000; Atlanta, GA.

48. Akin MD, Weingand KW, Hengehold DA, et al. Continuous low-level topical heat in the treatment of dysmenorrhea. ObstetGynecol. 2001;97:343–9.

49. Creatsas G, Deligeoroglou E, Zachari A, et al. Prostaglandins: PGF2alpha, PGE2, 6-keto-PGF1 alpha and TXB2 serum levels in dysmen-orrheic adolescents before, during and after treatment with oralcontraceptives. Eur J Obstet Gynecol Reprod Biol. 1990;36:292–8.


1. I have muscle pain from exercising. What can I doto ease the pain?

Apply an ice pack (ice cubes or a bag of frozen vegetableswrapped in a towel or other cloth to protect your skin) assoon as possible after an injury. Use the ice pack for no morethan 20 minutes at a time three or four times a day for 1 to 2days after the injury.

Try taking a pain reliever, such as acetaminophen (Tylenol isone brand), ibuprofen (Advil, Motrin IB, and Nuprin aresome brands), ketoprofen (Actron and Orudis KT are twobrands), naproxen sodium (Aleve is one brand), aspirin,choline salicylate (Arthropan), or magnesium salicylate(Doan’s is one brand). These medications are available overthe counter without a doctor’s prescription. Read the warn-ings and instructions on the label before taking thesemedications and ask your pharmacist or doctor if you haveany questions.

Once the first 48 hours after an injury have passed, use heattherapy instead of ice and go back to your normal activities(rest is no longer necessary or helpful).

ThermaCare Therapeutic HeatWraps are a new convenientform of low-level heat therapy. They are available in pharma-cies without a prescription. The wraps are portable,disposable, self-heating devices with a thin, flexible designthat allows them to be worn comfortably and discreetlybeneath clothing for up to 8 hours a day. They are availablein several different shapes. Back wraps are worn around thewaist and come in two sizes, with the S/M size correspondingto women’s pant size up to 8 and men’s waist size up to 34inches, and the L/XL size corresponding to women’s pant size9 and higher and men’s waist size 35 inches and higher. Theends of the wrap have a Velcro-like material that holds thewrap in place when the ends are overlapped. Neck-to-armwraps may be used on the neck, shoulder, wrist, or variousother places (that is, the shape allows the wrap to work wellon many parts of the body). The neck-to-arm wraps have anadhesive on the skin surface side that keeps the wrap in place.

2. I have painful menstrual cramps every month. Whatcan I do to relieve the pain?

Painful menstrual cramps may be treated with nonprescrip-tion medications, heat therapy, or both. Try taking ibuprofen(Advil, Motrin IB, and Nuprin are some brands), ketoprofen(Actron and Orudis KT are two brands), or naproxen sodium(Aleve is one brand) when the pain starts. These medicationsare available over the counter without a doctor’s prescription.Read the warnings and instructions on the label before tak-ing these medications and ask your pharmacist or doctor ifyou have any questions. If there is a possibility that youmight be pregnant, wait until your period starts before takingany of these medications. Take the medication on a regularschedule during the first 48 to 72 hours of your period, notonly when you have pain. If one medication does not workwell, try another because it might work better.

Answers to Common Questions About Muscle Pain,

Menstrual Cramps, and ThermaCare® Therapeutic HeatWraps

For MyPatients

This information was developed by the American Pharmaceutical Association, the National Professional Society of Pharmacists.

©2001, American Pharmaceutical Association.

Supported by an educational grant from Procter & Gamble.

ThermaCare Therapeutic HeatWraps are a convenient formof low-level heat therapy that help relieve pain from men-strual cramps and backache. They are available inpharmacies without a prescription. The wraps are portable,disposable, self-heating devices with a thin, flexible designthat allows them to be worn comfortably and discreetlybeneath clothing for up to 8 hours a day. They are availablein several different shapes. The menstrual wraps are shapedto fit on the lower abdomen and have an adhesive on theoutside surface that allows them to be worn inside the panties(the wrap adheres to the inside of the panties).

3. How are ThermaCare Therapeutic HeatWraps used?ThermaCare Therapeutic HeatWraps are activated by air, soopen the air-tight pouch only when you are ready to use awrap. Place the darker side against your skin. It may take upto 30 minutes for the wrap to heat completely. If the wrapdoes not seem warm enough after 30 minutes, it should betaken off and folded up for a few minutes before putting itback on. Wear ThermaCare wraps for a full 8 hours each day(use a new wrap each day) for 2 or 3 days in a row (the first 2days of the menstrual period) for the greatest benefit.

If your pain worsens or does not improve, contact a doctor.Do not use ThermaCare wraps for more than 7 days in a row(or more than 4 days in a row for menstrual cramping pain).

4. What side effects can ThermaCare TherapeuticHeatWraps cause?

ThermaCare Therapeutic HeatWraps can cause skin redness,irritation, and in rare cases, burning. Do not wear the wrapfor more than 8 hours in a 24-hour period. Check your skinfor redness and irritation periodically if you know that it issensitive to heat, feel that your tolerance to heat hasdecreased over the years, lie down or lean back against theproduct, or wear a tight-fitting belt or waistband over thewrap. If your skin is sensitive to heat, use ThermaCare wrapsduring the daytime before wearing them while sleeping.

Slight skin redness is normal in people using ThermaCareTherapeutic HeatWraps. However, if the redness persists formore than a few hours, remove the wrap until the rednessgoes away completely. To prevent prolonged redness in thefuture, wear ThermaCare wraps for a shorter period, withlooser clothing, or over a thin layer of clothing instead ofdirectly against your skin. If skin irritation or burningoccurs, remove the wrap immediately until the irritationresolves and the burn heals completely. If swelling, a rash, or other skin changes occur where the ThermaCare wrap isworn, stop using the wrap immediately and consult a doctorif the effect persists.

5. Is it safe to use ThermaCare TherapeuticHeatWraps with my medications?

There are no known interactions between ThermaCareTherapeutic HeatWraps and medications. However, do not useThermaCare with medicated lotions, creams, or ointmentsbecause the risk of a skin reaction may be increased.

Do not wear ThermaCare wraps over an estrogen skin patchor any other medicated skin patches. The effect of the heatfrom ThermaCare wraps on absorption of the medicationthrough the skin is unknown.

6. Where can I find additional information aboutThermaCare Therapeutic HeatWraps?

Ask your pharmacist or health care provider, call the manufacturer at (800) 323-3383, or go to http://www.thermacare.com on the World Wide Web.

This information was developed by the American Pharmaceutical Association, the National Professional Society of Pharmacists.

©2001, American Pharmaceutical Association.

Supported by an educational grant from Procter & Gamble.

American Pharmaceutical Association

The National Professional Society of Pharmacists

2215 Constitution Avenue, NWWashington, DC 20037-2985(800) 237-APhAhttp://www.aphanet.org

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