RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1.NAME OF THE CANDIDATE AND ADDRESS

Mr. PRITAM DEKA

GITANAGAR, GUWAHATI-21

ASSAM2.

NAME OF THE INSTITUTION KRUPANIDHI COLLEGE OF PHYSIOTHERAPY, BANGALORE

3.COURSE OF THE STUDY AND SUBJECT

MASTERS OF PHYSIOTHERAPY IN NEUROLOGICAL AND PSYCHOSOMATIC DISORDERS

4.DATE OF ADMISSION TO THE COURSE

14/06/2011

5. TITLE OF THE TOPIC:

THE COMBINED EFFICACY OF NEURAL MOBILIZATION WITH

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS)

VERSUS NEURAL MOBILIZATION ALONE FOR THE MANAGEMENT OF

CERVICAL RADICULOPATHY.

6. BRIEF RESUME OF THE INTENDED WORK

INTRODUCTION

Cervical radiculopathy is a common clinical diagnosis classified as a disorder of a nerve

root and most often is the result of a compressive or inflammatory pathology from a space

occupying lesion such as a disc herniation, spondylitic spur or cervical osteophyte.1

The average annual incidence rate of cervical radiculopathy is 83/100,000 for the American

Population in its entirety with the increased prevalence occurring in fifth decade of life.1

The location and pattern of symptoms will vary depending on nerve root level affected and

can include sensory and motor alterations if the dorsal and/or ventral root is involved. Cervical

radiculopathy primarily presents with unilateral motor and sensory symptoms into the upper limb

with muscle weakness (myotome), sensory alteration (dermatome), reflex hypoactivity and

sometimes focal activity being the primary sign. Patients usually present with complaints of pain,

numbness, tingling and weakness in the upper extremity which often result in significant functional

limitations and disability. 2

Acute radiculopathies are commonly associated with disc herniation whereas chronic types

are more related to spondylosis.2

A multitude of Physical Therapy interventions have been proposed to be effective in the

management of cervical radiculopathy, including mechanical cervical traction, manipulation,

therapeutic exercises and modalities.1

Mobilization of the nervous system was described by Maitland in 1985, Elvey in 1986, and

refined by Butler in 1991 as an adjunct to assessment and treatment of neural pain.3

Neural tissue mobilization techniques are passive or active movements that focus on

restoring the ability of the nervous system to tolerate the normal compressive, friction, and tensile

forces associated with daily and sport activities.4

Transcutaneous electrical nerve stimulation is an ancient but newly discovered modality.

Initially intended for use in chronic pain syndromes, transcutaneous electrical nerve stimulation may

be even more useful in managing acute pain. Although procedures for the use of this device are

relatively simple, additional knowledge about selecting and adjusting the device as well as clinical

experience will largely determine the degree of success obtained with this modality.5

Transcutaneous electrical nerve stimulation (TENS) has been increasingly used in physical

therapy for the relief of acute and chronic pain.6

TENS is particularly suited for the treatment of pain of neurogenic origin, including

peripheral nerve injury, radiculopathies, compression syndromes, causalgia, post-herpetic neuralgia,

and intercostal neuritis.7

The NDI is reliable, valid, and responsive in numerous patient populations, including patients

with acute and chronic conditions, as well as those suffering from neck pain associated with

musculoskeletal dysfunction, whiplash-associated disorders, and cervical radiculopathy.8

The NDI is the oldest and most widely used instrument for self-reporting of disability due

to neck pain.9

The reliability of the VAS is moderate to good as a single-item instrument measuring

disability in chronic musculoskeletal pain patients .10

6.1 NEED FOR THE STUDY

The pain of cervical radiculopathy may be very disabling and can interfere with the normal

activity of the individual.11

The treatment modes should target at the reduction of pain, which is mostly due to the

neural compression in origin.11

Various studies in the past have shown the improvements due to the individual application

of neural mobilization technique and TENS. But the studies related to comparative and combined

efficacy of these two interventions are very rare and very precarious.

Thus, the proposed study intends to find the efficacy of combination of neural mobilization

with TENS versus only neural mobilization for the management of cervical radiculopathy.

6.2 OBJECTIVES OF STUDY

(A) OBJECTIVES:

To study the effects of neural mobilization on cervical radiculopathy.

To study the effects of transcutaneous electrical nerve stimulation (TENS) on

cervical radiculopathy.

To compare the effects of neural mobilization and transcutaneous electric nerve

stimulation over only neural mobilization on cervical radiculopathy.

(B) HYPOTHESIS

NULL HYPOTHESIS:

There is no significant difference exists between Group I receiving both neural

mobilization and TENS and Group II receiving only neural mobilization on pain and disability

status.

ALTERNATIVE HYPOTHESIS:

There is significant difference exists between

Group I receiving both neural mobilization and TENS and Group II getting only neural

mobilization on pain and disability status.

6.3REVIEW OF LITERATURE

Review of cervical radiculopathy

1) Mark A. Waldrop (2006)12 cervical disc herniation and osteophytosis are the two most

common space occupying lesions that cause cervical radiculopathy. A cervical disc

herniation frequently impinges or encroaches upon the cervical nerve root, causing

inflammation.

2) Tanaka N et al (2000)13 the impingement of the cervical nerve root causes radicular

symptoms into the ipsilateral upper extremity. The radicular symptoms tend to follow a

dermatomal pattern, upon which cervical nerve root is impinged.

3) Butler (1991)14 repetitive compressive, tensile, friction and vibration forces acting near

anatomically narrow tissue spaces through which neural structures pass can cause

mechanical irritation.

4) Cavanaugh (1995)15; Garfin, et al (1991)16 injured somatic tissues adjacent to nerve

structures releases inflammatory substances that can chemically irritate neural tissues.

5) R.J. Nee et al (2006)4 pathophysiological and pathomechanical responses to nerve injury

affect the vascular, connective tissue and impulse conducting tissue system of nervous

system.

6) Devor and Seltzer (1999)17 an injured segment of peripheral nerve and its associated

DRG may develop the ability to repeatedly generate their own impulses. The main

features of AIGS are mechanosensitivity, chemosensitivity and spontaneous firing.

7) Bove et al (2003)18 axonal Mechanosensitivity and spontaneous discharge secondary to

neural inflammation appear to develop primarily in A delta and C fibers that innervate

deep structures.

Review of neural mobilization and TENS

1) Shacklock (2005)19 it is hypothesized that neural mobilization techniques can have a

positive impact on symptoms of radiculopathy by improving intraneural circulation,

axoplasmic flow, neural connective tissue viscoelasticity and by reducing sensitivity

of AIGS. Gliding techniques or sliders are neurodynamic maneuvers that attempt to

produce a sliding movement between neural structures and adjacent non neural

tissues and they are executed in a non-provocative fashion.

2) Vicenzino et al (1996)20 a cervical lateral glide technique has been shown to produce

immediate reduction in patients with neurogenic neck-arm pain.

3) Cleland et al (2004)21; George (2002)22 tensile loading technique, with or without

‘sliders’, have also been used successfully in case studies describing

patients with signs of increased neural tissue mechanosensitivity.

4) Richard F. Ellis (2008)23 conducted a study on systemic review of randomized

controlled trials with an analysis of therapeutic efficacy of neural mobilization in

relation to the pathology of nervous system and concluded that neural mobilization is

advocated for treatment of neurodynamic dysfunction. Regardless of the underlying

construct, it is vital that the nervous system is able to adapt to mechanical loads, and

it must undergo distinct mechanical events such as elongation, sliding, cross-

sectional change, angulations and compression. If these dynamic protective

mechanisms fails, the nervous system is vulnerable to neural edema, ischemia,

fibrosis and hypoxia, which may cause altered neurodynamics. When neural

mobilization is used for treatment of adverse neurodynamics, the primary theoretical

objectives is to attempt to restore the dynamic balance between the relative

movement of neural tissues and surrounding mechanical interfaces, thereby allowing

reduced intrinsic pressure on the neural tissue and thus promoting optimum

physiological function.

5) Scott F.Nadler et al (2004)24: A review on Nonpharmacological management of pain states

that TENS has been used to treat patients with various conditions, including neck and low

back pain. Success may be dictated by many factors, including electrode placement,

chronicity of the problem, and previous modes of treatment. TENS is generally used in

chronic pain conditions and not in indicated in the initial management of acute cervical or

lumbar spine pain. Overall, research is limited in regard to the isolated use of TENS in the

treatment of patients with acute cervical spine disorders, though it has been used in

combination with ROM exercises, spray and stretch, and myofascial release.

6) Chiu TT et al (2005)25 : a randomized trial of TENS and exercise was done for patients

with chronic neck pain.218 patients were randomized into three groups, receiving either

TENS over the acupuncture points plus irradiation (TENS group), exercise training plus

infrared radiation (exercise group) or infrared irradiation alone; twice a week for six weeks.

After the six weeks of treatment, patients in the TENS and exercise group had a better and

clinically relevant improvement in disability, isometric neck strength and pain.

7) Haymo W Thiel, (1987)7: reviews three cases in which radiculopathies of the cervical and

lumber spine were successfully managed by the use of TENS in addition to, or instead of

spinal manipulative therapy and concluded that essentially TENS may be used to treat any

localized pain of somatic or neurogenic origin provided paraesthesia can be obtained in the

area of the pain. TENS is particularly suited for the treatment of pain of neurogenic origin

including radiculopathies.

8) Howard Vernon (2008)9 reviews the history of the neck disability index (NDI) and

the current state of the research into its psychometric properties-reliability, validity,

and responsiveness as well as its translations and summarized that the NDI is the

most strongly validated instrument for assessing self-rated disability in patients with

neck pain.

9) JOY C. MACDERMID (2009)8 did a literature review on “Measurement Properties

of the Neck Disability Index: A Systematic Review” and mentioned in conclusion

point that NDI is reliable, valid, and responsive in numerous patients with acute and

chronic conditions as well as those suffering from neck pain associated with

musculoskeletal dysfunction, whiplash-associated disorders and cervical

radiculopathy.

10) Anne M Boonstra (2008)10 did a study on the reliability and validity of the VAS

scale for disability in patients with chronic musculoskeletal pain and concluded that

the reliability of VAS scale for disability is moderate to good.

7.MATERIALS AND METHOD

7.1 SOURCE OF DATA

The patients with cervical radiculopathy in the outpatient department of Krupanidhi

College of Physiotherapy and other Hospitals in and around Bangalore.

(A) POPULATION

Male/female subjects who diagnosed and confirmed by physician or medical

practitioner with cervical radiculopathy between the age group of 25-68 years.11

(B) SAMPLE SIZE

30 male subjects, age ranging from 25-60 years satisfying the inclusion and

exclusion criteria are divided into two groups-15 subjects in each group.

MATERIALS USED FOR THE STUDY

Couch.

TENS machine.

Assessment chart.

7.2 METHOD OF COLLECTION OF DATA:

(A) SAMPLING TECHNIQUES:

Simple Random sampling technique.

(B) OUTCOME MEASURES:

Visual analog scale,

Neck disability index.

(C) METHODOLOGY:

(I) STUDY DESIGN:

Comparative study with pre and post test design

(II) INCLUSION CRITERIA: 2, 11

Age: 25-68 years of either sex.

Cervical radiculopathy as per diagnosed by orthopaedician or

neurophysician.

The presence of four positive examination findings in the subjects will

be included in the study :

a) Upper limb tension test.

b) Spurling’s test.

c) Cervical distraction test.

(III) EXCLUSION CRITERIA:11, 7

Presence of any contraindication for TENS,

Presence of any contraindication for neural mobilization,

Patients on medications for cervical radiculopathy,

Upper extremity symptoms due to cord compression and CNS cause.

Thoracic outlet syndrome.

(IV) PROCEDURE:

The subjects after the preliminary assessment by the therapist, permission from

the concerned patient will be taken initially. Prior information about the study will be given. The

purpose of the study will be explained to all the subjects who volunteered to take part in the study

An informed consent will be taken from each one of them. The subjects will be selected based on

the inclusion and exclusion criteria.

About 30 male/female subjects will be assessed as cervical radiculopathy and are

selected for the study. This includes unilateral cervical radiculopathy. They will be categorized at

random into two groups as group receiving neural mobilization and TENS (experimental group I)

and group receiving only neural mobilization (experimental group II) with 15 patients in each group

after taking informed consent.

Patients in both group I and group II will be assessed before starting treatment.

Pre treatment measurement will be taken by using Visual analog scale (VAS) for pain and Neck

Disability Index for functional outcome. VAS and NDI will be carried out on the first day of

treatment procedure (pre- treatment evaluation) and on 7th day of treatment procedure (post-

treatment evaluation) for all the patients.

There by the scores of pre and post treatment are compared for both the visual

analog scale (VAS), Neck Disability Index (NDI).

V) INTERVENTION:

In this study 30 male subjects will be assessed clinically as cervical

radiculopathy. These subjects are categorized into two groups-group I and group II, each group

consists 15 subjects. Group I and groupII subjects will be assessed for nerve affection using upper

limb tension tests :

ULTT 1 : for Median nerve, Anterior interosseous nerve.

ULTT 2a : for Median nerve, Musculocutaneous nerve, Axillary nerve.

ULTT 2b : for Radial nerve.

ULTT 3 : for Ulnar nerve.

Depending on the affected nerve neural mobilization will be given to both Group I and Group II.

Group I: will receive

1)TENS7:

Frequency : 40-70 Hertz.

Intensity : as per patient’s tolerance.

Pulse Duration : 10- 50 Micro secs.

Duration : 20 min.

The treatment will consist of 10 sessions. 5 times/week, for 2 weeks.

Electrode Placement: Area of greatest intensity of pain.

2) Neural Mobilization 2, 26, 27: Depending on the affected nerve neural mobilization will be given.

The treatment will consist of 10 sessions, 5times/week for 2 weeks. The patient is positioned in

neurodynamic test position according to the involved nerve and required slinding or glinding

techniques will be used. There are no set techniques or recipe treatment for cervical radiculopathy so

neural mobilization technique will be based on Clinical Reasoning.

Group II: will receive only Neural Mobilization.

VI) OUTCOME:

Every treatment given for one time per session/day for a total of 5 days

continuously. If any subject misses any session they will be excluded from the study. Pre and post

therapy session includes assessment by visual analog scale, Neck Disability scale.

(VII) STATISTICAL ANALYSIS:

t-tests.

Man-whitney test.

Wilcoxon’s test.

7.3 Does the study require any investigation or intervention to be conducted on

patients or other humans or animals? If so please describe.

Yes, the study will be conducted among cervical radiculopathy patients after taking their

informed consent and the study involves neural mobilization and TENS in cervical radiculopathy.

7.4 Has ethical clearance been obtained from the subject and the institution?

Yes, ethical clearance been obtained from the subjects and the Institution.

8. LIST OF REFERENCES:

1) Cleland JA, Whitman JM, Fritz JM, Palmer JA: Manual Physical Therapy, Cervical

Traction, and Strengthening Exercises in Patients with Cervical Radiculopathy: A

Case Series: Journal of Orthopaedic & Sports Physical Therapy. Volume 35. Number

12. December 2005.

2) David J. Magee, Professor Department of Physical therapy, faculty of Rehabilitation

Medicine, University of Alberta, Edmonton, Alberta, Canada : ORTHOPEDIC

PHYSICAL ASSESSMENT, FIFTH EDITION, pp: 137, 163-167.

3) Christopher R. Showalter, LPT, OCS, COMT, FAAOMPT, FABS and Erik Van

Doorne, LPT, MAPTA, FABS: The Role of Neurodynamics in the Carpal Tunnel

Patient with Double Crush Syndrome. Maitland Australian Physiotherapy Seminar.

2007.

4) Robert J. Nee a,*, David Butler b a School of Physical Therapy, Pacific University,

Forest Grove, OR 97116, USA b Neuro Orthopedic Institute, Adelaide City West, SA,

Australia: Management of peripheral neuropathic pain: Integrating neurobiology,

neurodynamics, and clinical evidence. Physical Therapy in Sport 7 (2006) 36-49.

5) Lampe GN: Introduction to the use of transcutaneous electrical nerve stimulation

devices. Phys Ther. 1978 Dec; 58(12):1450-4.

6) Ronald Melzack, Phyllis Vertere and Lois Finch: Transcutaneous Electric Nerve

Stimulation for Low Back Pain. PHYSTHER.1983; 63:489-493.

7) Haymo W Thiel, DC*, J David Cassidy, DC, MSc (ortho), FCCS (C)**, Dale R

Mierau, BSPE, DC, DCCS(C)**: Treatment of peripheral extremity pain with TENS:

a report of three cases. The Journal of the CCA/volume 31 No.3/September 1987.

8) JOY C. MACDERMID, PhD1. DAVIDM. WALTON, MSc2. SARAH AVERY,

MScPT3. ALANNA BLANCHARD, MScPT3.EVELYN ETRUW, MScPT3.

CHERYL MCALPINE, MScPT3. CHARLIE H. GOLDSMITH, PhD4: Measurement

Properties of the Neck Disability Index: A Systemic Review. JOURNAL OF

ORTHOPAEDIC AND SPORTS PHYSICAL THERAPY.VOLUME 39, NUMBER

5 MAY 2009

9) Howard Vernon, DC, PhD: THE NECK DISABILITY INDEX: STATE-OF-THE-

ART, 1991-2008. Journal of Manipulative & Physiological Therapeutics, volume 31,

number 7, 2008.

10) Anne M Boonstra, Henrica R Schiphorst Preuper, Michiel F Reneman, Jitze B

Posthumus, Roy E Stewart: Reliability and validity of the visual analogue scale for

disability in patients with chronic musculoskeletal pain. International journal of

rehabilitation research, (impact factor: 0.36). 07/2008; 31(2):165-9. DOI:

10.1097/MRR.0b013e3282fc0f93.

11) Sanjiv Kumar, Principal & Professor KLES College of Physiotherapy, Hubli: A

prospective randomized controlled trial of neural mobilization and Mackenzie

manipulation in cervical radiculopathy. Indian Journal of Physiotherapy and

Occupational Therapy, an International Journal, volume 4, number 3, July-September

2010.

12) Mark A. Waldrop, PT, DPT: Diagnosis and Treatment of Cervical Radiculopathy

Using a clinical Prediction Rule and a Multimodal Intervention Approach: A Case

Series. Journal of Orthopaedic & Sports Physical Therapy. Volume 36. Number 3.

March 2006.

13) Tanaka N, Fujimoto Y, An HS, Ikuta Y, Yasuda M: The anatomic relation

among the nerve roots, intervertebral foramina, and intervertebral discs of the

cervical spine. Spine. 2000;25:286-291.

14) David S. Butler.: Mobilisation of the nervous system, (1991), pp 55-69

15) Cavanaugh, J. Neural mechanisms of lumbar pain. Spine, 20, (1995), pp 1804–1809.

16) Garfin, S., Rydevik, B., & Brown, R. : Compressive neuropathy of spinal nerve

roots: A mechanical or biological problem? Spine, 16, (1991), pp 162–166.

17) Devor, M., & Seltzer, Z. : Pathophysiology of damaged nerves in relation to chronic

pain. In P. Wall & R. Melzack (Eds.), Textbook of pain (4th ed., pp. 129–164)

(1999).

18) Bove, G., & Light, A.: The nervi nervorum: Missing link for neuropathic pain?

Pain Forum, 6, (1997), pp 181–190.

19) Shacklock, M.: Clinical neurodynamics: A new system of musculoskeletal

treatment (2005).

20) Vicenzino, B., Neal, R., Collins, D., & Wright, A.: The displacement, velocity and

frequency profile of the frontal plane motion produced by the cervical lateral glide

treatment technique Clinical Biomechanics, 14, pp 515–521, 1999.

21) Cleland, J., Hunt, G., & Palmer, S.: Effectiveness of neural mobilization in the

treatment of a subject with lower extremity peripheral neurogenic pain: A single-

case design. Journal of Manual and Manipulative Therapy, 12, 143–152. 2004.

22) George, S.: Characteristics of patients with lower extremity symptoms treated

with slump stretching: A case series. Journal of Orthopaedic and Sports Physical

Therapy, 32, 391–398. 2002.

23) Richard F. Ellis, B. Phty, Post Grad Dip, Wayne A. Hing, PT, PhD: Neural

Mobilization: A Systematic Review of Randomized Controlled Trials with an Analysis

of Therapeutic Efficacy. The Journal of Manual & Manipulative Therapy. Vol. 16 No.

1, 2008.

24) Scott F. Nadler, DO: Nonpharmacologic Management of Pain. Author Affiliations:

Dr Nadler is a consultant to Procter & Gamble. Correspondence to Scott F. Nadler,

DO, Professor, University of Medicine and Dentistry of New Jersey—New Jersey

Medical School, 90 Bergen St, Suite 3100, Newark, NJ 07003-2425. E-

mail: Sfnadler@cs.com

25) Chiu TT, Hui-Chan CW, Chein G: A randomized clinical trial of TENS and exercise

for patients with chronic neck pain. Clin Rehabil. 2005 Dec;19(8):850-60.

26) JANSON M. BENECIUK, PT, DPT, FAAOMPT1, MARK D. BISHOP, PT, PhD2,

STEVEN Z. GEORGE, PT, PhD2: Effects of Upper Extremity Neural Mobilization on

Thermal Pain Sensitivity: A Sham-Controlled Study in Asymptomatic Participants.

Journal of Orthopaedic and Sports Physical Therapy, volume 39, number 6, June

2009.

27) Michel W. Coppiteresa,b*, David S Butlerb: Do ‘sliders’ slide and ‘tensioners’ tension?

An analysis of neurodynamic techniques and considerations regarding their

applications. Manual Therapy 2007.

9. SIGNATURE OF CANDIDATE

Mr. PRITAM DEKA10. REMARKS OF GUIDE

PRESENTED TO THE RESEARCH COMMITTEE AND APPROVED

11. 11.1 NAME AND DESIGNATION OF GUIDE

Mrs. SARULATHA (MPT)ASSISTANT PROFESSOR

11.2 SIGNATURE

11.3 CO-GUIDE (if any)

11.4 SIGNATURE

11.5 HEAD OF THE DEPARTMENT MR. RAMESH KUMAR K.(MPT)

PROFESSOR

11.6 SIGNATURE

12 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL

12.2 SIGNATURE