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Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review) Milne S, Welch V, Brosseau L, Saginur M, Shea B, Tugwell P, Wells G This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2005, Issue 2 http://www.thecochranelibrary.com 1 Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review) Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

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Transcutaneous electrical nerve stimulation (TENS) for

chronic low-back pain (Review)

Milne S, Welch V, Brosseau L, Saginur M, Shea B, Tugwell P, Wells G

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library2005, Issue 2

http://www.thecochranelibrary.com

1Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

T A B L E O F C O N T E N T S

1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2SYNOPSIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW . . . . . . . . . . . . . . . . . .

3SEARCH STRATEGY FOR IDENTIFICATION OF STUDIES . . . . . . . . . . . . . . . . . . . .

3METHODS OF THE REVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4DESCRIPTION OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4METHODOLOGICAL QUALITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6NOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6POTENTIAL CONFLICT OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . .

6ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10Characteristics of included studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13Characteristics of excluded studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14Table 01. Clinical Relevance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14GRAPHS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14Comparison 01. TENS vs Placebo, end of treatment (2 days) . . . . . . . . . . . . . . . . . . .

14Comparison 02. TENS vs Placebo, end of treatment (approx 1 month) . . . . . . . . . . . . . . . .

15Comparison 03. TENS vs Placebo, Follow up (3 months) . . . . . . . . . . . . . . . . . . . . .

15Comparison 04. TENS vs Placebo, Follow up (6 months) . . . . . . . . . . . . . . . . . . . . .

15Comparison 05. TENS- High Quality vs. Low Quality, End of Treatment (1 month) . . . . . . . . . . .

15INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15COVER SHEET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16GRAPHS AND OTHER TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16Comparison 05. 01 Pain, continuous, patient-assessed . . . . . . . . . . . . . . . . . . . . . .

17Comparison 05. 01 Pain, continuous, patient-assessed . . . . . . . . . . . . . . . . . . . . . .

17Comparison 05. 02 Pain Improvement, VAS (0-100) . . . . . . . . . . . . . . . . . . . . . .

18Comparison 05. 03 Pain frequency (1 - 5, 1 = never, 5 = all the time) . . . . . . . . . . . . . . . . .

18Comparison 05. 04 Stiffness (VAS) . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19Comparison 05. 05 Flexion ROM . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19Comparison 05. 06 Extension (degrees) . . . . . . . . . . . . . . . . . . . . . . . . . . .

20Comparison 05. 07 Function (Change from baseline) . . . . . . . . . . . . . . . . . . . . . .

20Comparison 05. 08 Self-Rated Activity Level . . . . . . . . . . . . . . . . . . . . . . . . .

21Comparison 05. 09 Use of services . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21Comparison 05. 10 Patient Satisfaction . . . . . . . . . . . . . . . . . . . . . . . . . . .

22Comparison 05. 11 McGill Work . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22Comparison 05. 12 Lasegue’s SLR (degrees) . . . . . . . . . . . . . . . . . . . . . . . . .

23Comparison 05. 13 SLR (degrees) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23Comparison 05. 01 Pain, continuous, patient-assessed . . . . . . . . . . . . . . . . . . . . . .

24Comparison 05. 01 Pain, continuous, patient-assessed . . . . . . . . . . . . . . . . . . . . . .

24Comparison 05. 01 Pain, continuous, patient assessed . . . . . . . . . . . . . . . . . . . . . .

25Comparison 05. 02 Disability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iTranscutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Transcutaneous electrical nerve stimulation (TENS) forchronic low-back pain (Review)

Milne S, Welch V, Brosseau L, Saginur M, Shea B, Tugwell P, Wells G

This record should be cited as:

Milne S, Welch V, Brosseau L, Saginur M, Shea B, Tugwell P, Wells G. Transcutaneous electrical nerve stimulation (TENS) for chronic

low-back pain. The Cochrane Database of Systematic Reviews , Issue . Art. No.: CD003008. DOI: 10.1002/14651858.CD003008.

This version first published online: 23 October 2000 in Issue , .

Date of most recent substantive amendment: 03 August 2000

A B S T R A C T

Background

Low back pain (LBP) affects a large proportion of the population. Transcutaneous electrical nerve stimulation (TENS) was introduced

more than 30 years ago as an alternative therapy to pharmacological treatments for chronic pain. However, despite its widespread use,

the effectiveness of TENS is still controversial.

Objectives

The aim of this systematic review was to determine the efficacy of TENS in the treatment of chronic LBP.

Search strategy

We searched MEDLINE, EMBASE, PEDro and the Cochrane Controlled Trials Register up to June 1, 2000.

Selection criteria

Only randomized controlled clinical trials of TENS for the treatment of patients with a clinical diagnosis of chronic LBP were included.

Abstracts were excluded unless further data could be obtained from the authors.

Data collection and analysis

Two authors independently selected trials and extracted data using predetermined forms. Heterogeneity was tested with Cochran’s Q

test. A fixed effects model was used throughout for continuous variables, except where heterogeneity existed, in which case, a random

effects model was used. Results are presented as weighted mean differences (WMD) with 95% confidence intervals (95% CI), where the

difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences (SMD)

were calculated by dividing the difference between the treated and control by the baseline variance. SMD were used when different

scales were used to measure the same concept. Dichotomous outcomes were analyzed with odds ratios.

Main results

Five trials were included, with 170 subjects randomized to the placebo group receiving sham-TENS and 251 subjects receiving active

TENS (153 for conventional mode, 98 for acupuncture-like TENS). The schedule of treatments varied greatly between studies ranging

from one treatment/day for two consecutive days, to three treatments/day for four weeks. There were no statistically significant

differences between the active TENS group when compared to the placebo TENS group for any outcome measures. Subgroup analysis

performed on TENS application and methodological quality did not demonstrate a significant statistical difference. Remaining pre-

planned subgroup analysis was not conducted due to the small number of included trials and the variety of outcome measures reported.

Authors’ conclusions

The results of the meta-analysis present no evidence to support the use of TENS in the treatment of chronic low back pain. Clinicians

and researchers should consistently report the characteristics of the TENS device and the application techniques used. New trials on

TENS should make use of standardized outcome measures. This meta-analysis lacked data on how TENS effectiveness is affected by

four important factors: type of applications, site of application, treatment duration of TENS, optimal frequencies and intensities.

1Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

S Y N O P S I S

There is no evidence from trials to show the effects of transcutaneous electrical nerve stimulation (TENS) for chronic low back pain.

Low back pain (LBP) affects a large number of people and can severely limit work and recreation. Transcutaneous electrical nerve

stimulation (TENS) is a therapeutic non-invasive therapy that stimulates nerves electrically via electrodes placed onto the skin. The

review of trials found no evidence to show the effectiveness of TENS when used alone for chronic low back pain. More research is

needed.

B A C K G R O U N D

Low back pain (LBP) is the largest cause of workmen’s compensa-

tion in the USA and Canada. Sixty to 90% of the adult population

is at risk of developing LBP at some point in their lifetime (An-

dersson, 97, Coste, 89, Deyo, 87a, Skovron, 92). Of those who

develop acute LBP, 30% develop chronic LBP (Bowman, 91). LBP

has a significant impact on functional ability, restricting occupa-

tional activities with marked socio-economic repercussions (Van

Tulder, 99,Deyo, 87b).

The actual treatment for LBP is comprised of a number of dif-

ferent interventions such as drug therapy, surgery, physiotherapy,

and alternative therapies. The treatment goals are to relieve pain,

reduce muscle spasm, improve range of motion and strength and

ultimately improve functional status. The effectiveness and sever-

ity of adverse side effects of these treatments and physical ther-

apeutic modalities for LBP varies (Delitto, 93,Ottenbacher, 95,

Schlapbach, 91, Stratford, 93).

Transcutaneous electrical nerve stimulation (TENS) is a therapeu-

tic non-invasive modality mainly used for pain relief by electrically

stimulating peripheral nerves via skin surface electrodes (APTA,

93, Barr, 99). TENS was added more than 30 years ago to ex-

isting physical agents used in medicine and physiotherapy in the

treatment of LBP. The development and application of TENS was

based on the underlying Gate Theory conceptualised by Melzack

and Wall (Melzack and Wall, 82).

According to this theory, the TENS mechanism generates neuro-

regulatory peripheral and central effects (Coderre, 93,Han,

91,Janko, 80,Willer, 88) which modulate pain transmission

(Levin, 93,Fields,Melzack and Wall, 82). It was proposed that

by applying low intensity stimulation, the nervous system could

modify the perception of pain by counter-stimulating the large

diameter fibres (Melzack, 65).

Higher intensity of TENS are more likely effective to facilitate

these neuro-regulation and modulation (Langley, 84, Melzack,

75). However, several types of TENS applications, differing in in-

tensity and electrical characteristics, are used in clinical practice:

1) high frequency (40-150 Hz, 50-100usec pulse width, mod-

erate intensity); 2) low frequency (1-4 Hz, 100-400 usec pulse

width, high intensity); 3) burst frequency (1-4Hz with high inter-

nal frequency, 100-250 usec pulse width, high intensity) and 4)

hyperstimulation (1-4Hz, 10-500 msec pulse width, high inten-

sity) (Jette, 97).

A meta-analysis on the effect of TENS on various clinical con-

ditions showed that TENS has no effect on musculoskeletal pain

syndromes (Reeve, 96). However, this meta-analysis did not ex-

amine LBP alone. A more recent meta-analysis (Van Tulder, 99)

has led to the same conclusion. These authors (Van Tulder, 99)

did not restrict their inclusion criteria to placebo-controlled RCTs.

Furthermore, the Philadelphia Panel (2001a; 2001b) recommends

there is poor evidence to include or exclude TENS alone as an in-

tervention for chronic LBP. This EBCPG is in concordance with

the BMJ (BMJ, 99) recommendations. In contrast, the Québec

Task Force (Quebec Task Force) recommended TENS as a reha-

bilitation modality for symptomatic pain relief, but this recom-

mendation included other forms of electroanalgesia. Insufficient

information regarding adverse effects was reported by BMJ (BMJ,

99).

The aim of this systematic review was to determine the effec-

tiveness of TENS in the treatment of chronic LBP. A secondary

objective was to determine the most effective method of admin-

istering TENS for chronic LBP, including the optimal: 1) fre-

quency/intensity; 2) application techniques; 3) duration of treat-

ment; and 4) site of application.

O B J E C T I V E S

To determine the effectiveness of transcutaneous electrical nerve

stimulation (TENS) in the treatment of chronic low back pain.

C R I T E R I A F O R C O N S I D E R I N G

S T U D I E S F O R T H I S R E V I E W

Types of studies

Only randomized controlled trials (RCTs) with greater than 5

patients with LBP, per group, were eligible. This sample size limit

was applied based on clinical experience.

Types of participants

Only trials with outpatients aged 18 years and over with a diagnosis

of chronic (greater than 12 weeks) low back pain were included.

2Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Only patients with low back pain of musculoskeletal origin were

selected. Radicular signs were not excluded. Subacute low back

pain was excluded, defined as a population with pain duration

between 4 and 12 weeks.

Types of intervention

All modes of TENS, including acupuncture-like, were included

in this review. Sham TENS was considered an acceptable placebo

group. Articles were excluded if either the active or placebo

treatment groups received TENS treatment percutaneously with

acupuncture needles. Acupuncture, even as a sham, may have ef-

fects on pain, stiffness, and physical disability (Takeda and Wes-

sel,94).

Types of outcome measures

The outcome measures included for analysis were the ones that are

most likely to be used in physical therapy for LBP and published

in paper by the International Back Group (Deyo, 98): 1) Pain;

2) Functional (for example, measured by the Roland Disability

Scale); 3) Well being (Ex. patient global assessment); 4) Disability;

5) Disability -special (Ex. loss of work, sick days); 6) Satisfaction

with care.

S E A R C H S T R A T E G Y F O R

I D E N T I F I C A T I O N O F S T U D I E S

See: search strategy

We searched MEDLINE up to June 2000, EMBASE to June

2000, the Cochrane Controlled Trials Register (CCTR), Issue

2, 2000 and The Physiotherapy Evidence Database (PEDro)

up to June 2000. Details of the search strategy are given in

the appendix. The electronic search was complemented by

the following hand searches: 1) Bibliographic references; 2)

Current Contents up to week 21, 2000 (to identify articles

not yet indexed in Medline); 3) Abstracts published in special

issues of specialized journals or in Conference Proceedings were

also included; 4) Co-ordinating offices of the trials registries of

the Cochrane Field of Physical and Related Therapies and the

Cochrane Musculoskeletal Group were contacted.

Reference lists were hand-searched for further identification of

published work, presentations at scientific meetings and personal

communications. Content experts were contacted for additional

studies and unpublished data. If data could not be obtained,

abstracts were not used.

The sensitive search strategy for RCTs described by Haynes et

al (Haynes, 94) was used and combined with the following text

words and Mesh terms to identify TENS and low back pain:

TENS:

exp electric stimulation therapy/

((electric$ adj nerve) or therapy).tw.

electrostimulation.tw.

electroanalgesia.tw.

(tens or altens).tw.

electroacupuncture.tw.

(high volt or pulsed or current).tw.

(electromagnetic or electrotherap$).tw.

Back pain:

exp back/

exp back injuries/

exp back pain/

back.hw,tw.

(spine or spinal).tw.

sacrococcygeal.tw.

lumbar.tw.

sciatica/ or sciatic$.tw.

lumbosacral.tw.

cauda equina.hw,tw.

backache.tw.

M E T H O D S O F T H E R E V I E W

Two authors (L.B.,S.M.) independently selected the trials to be

included in the review and all articles selected by at least one of

the authors were retrieved for closer examination. These authors

were not blinded to the journal or authors. There was no cut-off

based on methodological quality or source of financial support.

From each included trial, we collected information regarding

the trial design, patient characteristics, dosages and treatment

duration, and baseline and end of study outcomes. Follow-up

data were included where possible. Data concerning details of

the study population, intervention and outcomes were extracted

independently by two authors (M.S., S.M., L.B.). Differences in

data extraction were resolved by referring back to the original

article and establishing consensus. A third author was consulted to

help resolve differences. Additional information was sought from

the authors of the primary studies, when incompletely reported in

the publications.

Data on the outcomes from each trial were pooled to arrive at an

overall estimate of the effectiveness of TENS. Where possible, the

analyses were based on intention-to-treat data from the individual

trials. In cases where trials reported outcomes as graphs, the mean

scores and standard deviations were estimated from these graphs.

Subgroup and sensitivity analyses were attempted to determine the

effects of the method of TENS administration, methodological

quality and treatment duration on outcomes.

For continuous data, results are presented as weighted mean

differences (WMD). However, where different scales were used

to measure the same outcome or concept, standardized mean

differences (SMD) were used. For dichotomous data, an odds ratio

(OR) was calculated (Petitti 94). The OR cannot be interpreted

as a relative risk because prevalence of the outcome studied is high

3Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

(Henneken, 87). A test for heterogeneity was calculated using a

Chi square test. Fixed effects models were used throughout, unless

statistical heterogeneity was significant, in which case, a random

effects model was used. Publication bias was not assessed due to

the small number of included studies.

D E S C R I P T I O N O F S T U D I E S

The literature search identified 61 articles. The specialized reg-

ister of the Cochrane Field of Physical and Related Therapies,

the Cochrane Musculoskeletal Group and handsearches of refer-

ence lists provided no additional references. Contact with experts

yielded one trial (Jarzem, 97). Of these, 21 were potentially rele-

vant trials, and five met the inclusion criteria. Ten trials were ex-

cluded due to lack of control group or randomisation or placebo

comparison. Five were excluded because the number of patients

with chronic low back pain was too small (< 10) or the patients

did not meet the inclusion criteria (Lehmann, 83, Lundeberg,

84b, Jeans, 79,Schuster, 80,Thorsteinsson, 78). Two trials were

excluded for an inappropriate treatment group (Hackett, 88, Mac-

donald, 95). One RCT published in abstract form only was in-

cluded (Jarzem, 97). Data from this trial were obtained from the

authors with the assistance of the Cochrane Back Group Editorial

Board.

Of the five RCTs of TENS for chronic low back pain, four reported

pain or pain relief as an outcome. Physical measures such as lumbar

flexion / extension or SLR were reported by 2 trials and disability

on the Roland scale was reported by two trials.

The mean age ranged from 36 to 52 years and the mean time from

onset of low back pain varied from 4 to 12 years. The schedule of

treatments varied greatly between studies ranging from one treat-

ment/day for two consecutive days, to three treatments/day for

four weeks. All trials included patients with chronic low back pain

of musculoskeletal origin, however, not all the trials described the

subgroups of specific diagnosis (Ex. neurologic signs, disc involve-

ment, radiculopathy).

M E T H O D O L O G I C A L Q U A L I T Y

The quality of the studies was assessed by two independent au-

thors (L.B., S.M.) using a validated five point scale (Jadad, 96),

which includes the appropriateness of randomization (2 points),

appropriateness of blinding (2 points), and description of dropouts

and withdrawals (1 point). Differences in scoring were resolved by

consensus. A third author (V.W.) was consulted when necessary.

Consensus was reached for all trials. Studies were divided into low

and high quality, based on the median quality score to examine

the effect of the quality on the difference between active treatment

and placebo groups.

The median methodological quality was 2, with a range from 2 to

5. Two trials scored full points for randomization, one scored full

points for double blinding, and three did not report withdrawals

and dropouts.

R E S U L T S

A total of 170 subjects were allocated to placebo groups receiv-

ing sham-TENS and 251 subjects received active TENS (153 for

conventional mode, 98 for acupuncture-like TENS).

There was no significant heterogeneity for any comparisons, indi-

cating that the difference between treated and control groups was

consistent across trials. For all of the outcome measures assessed,

no significant difference was found between the active treatment

and placebo control groups. Three studies measured pain using

a visual analogue scale (VAS) at the end of treatment, with a to-

tal of 171 subjects (89 active TENS, 82 placebo). There was a

trend towards greater pain reduction with the active TENS appli-

cation compared to the placebo, however, this difference was not

statistically significant (SMD: -0.207 [95% CI: -0.508 - 0,095]).

When converted to the original units of the VAS, this represents

a difference of 4mm on a 100mm scale. The relative difference

in percentage change from baseline for each trial with pain as an

outcome ranged from 11% to 38% (Table 01).

For the subgroup analysis regarding high versus low quality appli-

cations, there was no difference in the effect on pain or function.

There was also no difference in pain and function between high

and low frequency applications for the time points reported. Due

to the small number of trials, the remaining pre-planned subgroup

analyses ( treatment duration, type of TENS application) were not

conducted.

D I S C U S S I O N

The results of this meta-analysis suggest that TENS does not have

a clinically important benefit on pain in patients with chronic LBP.

A difference of 4mm on a 100mm VAS was obtained. Furthermore

no evidence of effect on other outcomes. There is poor evidence

to include TENS alone as an intervention for chronic LBP. De-

spite several RCTs of TENS, no consistent benefit was shown on

clinically relevant outcomes (Deyo, 90a; Gemignani, 91, Jarzem,

97, Marchand, 93,Moore, 97). Sub-group analyses revealed no

significant differences between low and high quality studies and

high vs low frequency.

These results are in concordance with previous systematic reviews

for chronic LBP (Reeve, 96,Van Tulder, 99). These results are

also in agreement with the Philadelphia Panel (2001) and BMJ

evidence-based clinical practice guidelines (EBCPGs) which do

not recommend TENS for chronic LBP, but in conflict with the

QTF (Quebec Task Force) CPGs which recommended TENS

4Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

for pain relief. However, the QTF did not differentiate between

electroanalgesia and TENS and was not based on a systematic

review.

Various methodological biases were potentially introduced in the

individual trials. A misclassification bias related to the LBP condi-

tion studied is present with the lack of precise medical and phys-

iotherapy diagnoses observed (Binkley, 93,Delitto, 93,Delitto A

95,Delitto A 95,Magistro, 93, Marras, 95,Zimny, 95). Selection

bias could have occurred with the presence of heterogeneity of

clinical characteristics such age, prevalent versus incident cases,

stages of the disease, level of pain and presence or absence of neu-

rological deficits. However, differences in disease duration were

minimized by excluding studies with a mix of acute and chronic

conditions or mixed diagnoses other than sciatalgia.

The quality of the included papers was acceptable but low (median

2).There was no difference in effect between high versus low qual-

ity studies. Randomization was rarely adequate (i.e. performed

using computerized random number lists). Insufficient informa-

tion was noted in several RCTs about the treatment assignment

procedure. Inappropriate blinding could also lead to information

bias. Blinding is an issue with physical rehabilitation interven-

tions. Complete blinding is difficult to achieve because of visual

and other sensory differences between the active treatment and the

placebo as well as through unintended communication between

the patient and evaluator (Deyo, 90a). A valid placebo for TENS

is difficult to achieve since TENS involves cutaneous stimulation.

It has been suggested that the effect of TENS is due to a placebo

effect since placebo TENS has been shown to relieve pain relative

to a control group receiving no therapy (Jensen, 85).Few investi-

gators reported adequate information regarding withdrawals and

loss to follow-up and failed to indicate if they were considered in

the data analysis.

Characteristics of the device parameters and of the therapeutic

application could also affect the treatment effect size. There is a

marked heterogeneity among included studies. In some articles

these parameters are not even reported (Gemignani, 91,Jarzem,

97). A theoretical framework for the application of TENS similar

to the one proposed by Morin et al. should be considered (Morin,

96).

Specific therapeutic application of TENS is of key importance. For

example, Guieu et al. (Guieu, 91) observed positive results when

using mechanical vibrations simultaneously with TENS. Vibra-

tory stimulation has been recommended as part of the TENS ap-

plication, especially for chronic pain relief (Guieu, 91,Lundeberg,

84b,Tardy-Gervet, 93). None of the trials included in our review

included or mentioned vibratory stimulation. There is a need for

strict and rigorous RCTs of TENS using combined vibratory stim-

ulation.

The neuro-regulatory peripheral and central effects (Coderre,

93,Han, 91,Janko, 80,Willer, 88) of the TENS are thought to

be more effective with higher intensity applications (Langley, 84

,Morin, 96) such as with the acupuncture-like application. This ef-

fect was not captured by our sub-analyses involving acupuncture-

like application compared to placebo. According to Levin, both

conventional and acupuncture-like TENS excite afferent fibers

in the A-alpha-beta range (Levin, 93). The plausible effect is ex-

plained by the activation of intrinsic pain-suppressive systems

(Cheng, 80,Sjolund, 85) and the concomitant release of opiate and

non-opiate neuro-regulators (Han, 91,Han and Terenius„Peets,

85,Sjolund, 79). This effect was not captured by our sub-analyses

involving acupuncture-like application compared to placebo. This

observation may be due to the fact that the effectiveness of the

TENS application, especially for LBP is also influenced by a

number of risk factors (Andersson) including biological (Biering-

Sorenson, 86), psychosocial (Bigos, 91,Bongers, 93, Strong, 94,

Venning, 87), occupational (Hagberg, 92,Hope, 99,Riihimäki,

89, Svensson, 83,Winkel, 94) health indicators. Unfortunately, it

was not possible to examine these risk factors.

The development and use of a theoretical framework to rationalize

TENS and also to provide uniformity in reporting the character-

istics of the device and the therapeutic application in clinical set-

tings and in scientific reports are imperative (Morin, 96,Rothstein,

95). The large variability in methodological quality reflects the

need for standardization of reporting and conducting clinical trials

in physiotherapy. Standardized measurement of outcomes is also

recommended to facilitate scientific advances in clinical care for

LBP (Deyo, 98,Delitto A. 94). More information on responsive-

ness and the minimally important change in scores is needed for

most of the instruments for LBP management (Deyo, 98, Strat-

ford, 94Stratford, 96). Little is known about valid and sensitive

outcome measures in LBP (Van Tulder, 99) and more psychomet-

ric studies are needed. These recommendations will contribute to

evidence-based practice (Helewa, 00).

The effectiveness of conservative treatment of LBP is a complex

issue (Van Tulder, 99, Erhard, 94). Physical rehabilitation is de-

fined as a combination of physical agents. Rehabilitation special-

ists often use concomitant treatment interventions in their daily

practice (Gam, 95). Each individual modality is usually an adjunct

therapy. Certain modalities such as thermotherapy and TENS are

used for pain relief or as a treatment preparation before the main

intervention. The use of single and specific interventions does not

reflect the complexity of the global approach adopted by rehabili-

tation specialists in real life clinical situations for the treatment of

chronic LBP.

The therapeutic application in daily practice of several concur-

rent rehabilitation interventions is based on empirical experience

(Gam, 95, Delitto, 93, Jette, 97) and the measurement of their

effects is complex (Delitto A. 94,Duckworth, 99). The practice

of rehabilitation requires a better theoretical basis (Delitto A. 94,

DeRosa, 92,Rothstein, 95, Morin, 96, Fritz, 98) and well-designed

controlled research (Schlapbach, 91).

5Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

In summary, this meta-analysis suggests that TENS is not effective

in reducing pain, improving functional status, increasing ROM

or activity in patients with chronic LBP. There is poor evidence to

include TENS alone as an intervention for chronic LBP. However,

there is no evidence regarding the effects in diagnostic subgroups

of LBP. Furthermore no evidence was found regarding the effects

of vibratory stimulation.

A U T H O R S ’ C O N C L U S I O N S

Implications for practice

The evidence from RCT’s does not support the use of TENS alone

in the treatment of chronic low back pain.

Implications for research

Further studies are needed to evaluate the efficacy of TENS com-

bined with vibratory stimulation in the treatment of low back

pain. These studies should report standardized, clinically relevant

outcome measures with special attention to the findings of this

meta-analysis regarding treatment application (Ex. low vs. high

frequency, type of applications or combined applications, treat-

ment duration, and site of application).

N O T E S

As of Issue 1, 2001, this current review by Milne et al replaces the

original review by Gadsby et al entitled, “ TENS and acupuncture-

like TENS for chronic low back pain” which was first published

Issue 2, 1997 and officially withdrawn Dec. 1999.

Any further questions may be directed to the Back Review Group

Coordinator @ [email protected]

P O T E N T I A L C O N F L I C T O F

I N T E R E S T

None known

A C K N O W L E D G E M E N T S

The authors wish to thank Jessie McGowan for her consultation

on the search strategy, Dr. Ghoname & Jarzem for providing data.

Thanks to Dr. Claire Bombardier and Andrea Furlan for assistance

obtaining unpublished data, and to Mathieu Nadeau for assisting

with data extraction.

S O U R C E S O F S U P P O R T

External sources of support

• CIGNA Foundation provided an educational grant USA

• Lucie Brosseau is an Ontario Ministry of Health & Long-Term

Care Career Scientist CANADA

Internal sources of support

• No sources of support supplied

R E F E R E N C E S

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T A B L E S

Characteristics of included studies

Study Deyo, 90a

Methods Randomized, double blind, parallel group

Sample size: total: 145, group 1: 36, group 2: 37, group 3: 36, group 4: 36

Treatment duration: 4 weeks

Follow up at 3 and 6 months

Participants Inclusion: low back pain > 3 months, with or without abnormal imaging or laboratory studies

Exclusion: history of cancer, use of corticosteriods / anticoagulant, maximal pain above T12, age > 70 yr or

< 18 yr, cardiac pace maker, known heart disease, severe coexisting disease, previous unevaluated neurologic

deficit, who can not be followed up, previous use of TENS, on disability compensation

Mean age: total: 51.4, group 1: 53.7, group 2: 53, group 3: 48.1, group 4: 50.6

Symptom duration: 4.1 yr

% females: total: 58, group 1: 58, group 2: 59, group 3: 58, group 4: 59

Patients completing: total: 125 at 4 weeks, 122 at 3 months, group 1: 31, group 2: 34, group 3: 31, group

4: 29

Compliance: 14%, 20 dropped out

%post surgery: total: 10, group 1: 19, group 2: 3, group 3: 10, group 4: 10

Disease: for most subjects there is no definitive diagnosis for low back pain

Interventions Group 1: TENS

Group 2: TENS + exercise ( 12 sequential exercises: 3 relaxation followed by 9 for flexibility for spine, hip,

lower extremities)

10Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Characteristics of included studies (Continued )

Group 3: no exercise + sham TENS

Group 4: sham TENS + exercise

TENS device characteristics: Epix 982 units

Amplitude: conventional: 30, acupuncture like: 100

Pulse width: NA

Pulse frequency: conventional: 80-100, acupuncture like: 2-4

Stimulation mode: conventional high frequency, acupuncture like low frequency

Mode of stimulation: modulated-pulse-rate for all

Electrodes placement: over the area of most severe pain; in sciatica on leg and back

Total number of electrodes: 4; each 5.5 cm in diameter

Treated time per session: 45 mn

Schedule of treatment: 3 times / day

Total number of treatment sessions: 4 weeks

Concurrent treatments: hot packs, written and oral advice for lifting, standing, resting positions

Outcomes Functional status

Pain

Physical measures

Use of services

Wish to continue TENS therapy

Notes Quality: 5 (2,2,1)

Allocation concealment A

Study Gemignani, 91

Methods Double blind, placebo controlled, parallel group, single intervention

Sample size: total: 20

Treatment duration: 3 weeks

Participants Inclusion: Ankylosing Spondylitis (New York criteria), lumbar pain and sitffness > 1 month, NSAID not

sufficient for treatment

Interventions Group A: TENS

Group B: placebo

TENS device characteristics: Agopik A86

Amplitude: NA

Pulse with: NA

Pulse frequency: 5

Stimulation mode: NA

Single / Dual channel: NA

Size of the head: NA

Electrodes placement: on the skin, lower back, standard acupuncture points

Total number of electrodes: 4

Time per session: 20 min

Schedule of treatment: 3 weeks

Total number sessions: 10

Concurrent treatments: paracetamol 1 in group A, 5 in group B ; other NSAIDs were discontinued 1 week

before trial

Outcomes Pain

Stiffness

Analgesic pill count

Notes Quality: 2 (1,1,0)

Allocation concealment D

11Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Characteristics of included studies (Continued )

Study Jarzem, 97

Methods Randomized, double blind, parallel group.

Sample size: total: 324; group 1: 83; group 2: 84; group 3: 78; group 4: 79.

Treatment duration: 28 days

Participants Inclusion: LBP

Mean age (SE): group 1: 47.3 (1.8); group 2: 45.4 (1.4); group 3: 43.1 (1.6); group 4: 44.4 (1.6).

Mean pain duration, yrs (SE): group 1: 10.1 (1.1); group 2: 9.0 (1.1); group 3: 9.4 (1.1); group 4: 12.2 (1.3).

% female : group 1: 51.8; group 2: 48.8; group 3: 43.6; group 4: 54.4.

Work missed, wks (SE): group 1: 16.5 (5.2); group 2: 22.1 (5.2); group 3: 13.5 (6.3); group 4: 30.3 (9.8)

Interventions Group 1: Sham-TENS

Group 2: TENS, conventional mode (ND)

Group 3: TENS, Acupuncture mode (ND)

Group 4: TENS, New-Wave mode (ND)

Outcomes McGill Activity (0-100)

McGill Work (0-100)

Disability (Roland)

ROM (Flexion / extension / SLR)

Isolift

Zung depression scale

Notes Quality: 2 (2,0,0)

Allocation concealment A

Study Marchand, 93

Methods Randomized, placebo controlled, single intervention

Sample size: total 42, group 1: 14, group 2: 12, group 3: 16

Treatment duration: 10 weeks

Follow-up: 6 months

Participants Inclusion: chronic pain > 6 months, complete medical work up, no relief from other appropiate therapy

Exclusion: Scoliosis > 15*, root compression and surgical indication, collapse of > 3 lumbar level, spondy-

lolisthesis > 1 cm, obesity > 20%, important psychological problems

Mean age: total: 36 (18-60), group 1: 35.46+/- 7.84, group 2: 35.08+/- 7.38, group 3: 37.25+/- 8.18

Symptom duration: total: 9 yr, group 1: 10.73+/- 7.08 yr, group 2: 8.83+/- 6.21, group 3: 6.51+/- 6.22

Males / Females: total: 20 / 22, group 1: 6/8, group 2: 6/6, group3: 8/8

Diseases: somatogenic pain, AS, RA, scoliosis < 15*, pyramidal syndrome

Interventions Group 1: TENS

Group 2: placebo TENS

Group 3: control, no treatment

TENS device characteristics: TENS 7720

Amplitude: low

Pulse with: 125 ms

Pulse frequency: 100

Stimulation mode: medtronic adjustable

Single / Dual channel: 2 channel

Size of the head: NA

Electrodes placement: dermatome of pain

Total number of electrodes: NA

Time per session: 30 mn

Schedule of treatment: 10 weeks

Total number session: 2 / week

Outcomes Pain intensity

12Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Pain unpleasantness

Notes Quality: 2 (1,1,0)

Allocation concealment B

Study Moore, 97

Methods Randomized, double blind, placebo-controlled trial, parallel group

Sample size: total : 28

Treatment duration : 2 days

Participants Inclusion: low back pain > 6 months, LBP unresponsive to previous treatments

Exclusion: cardiac pace maker, serious psychological disorder, previous TENS or NMES

Total mean age: 51.67 yr (26-80)

Mean symptom duration: 3.83 yr (2-10)

Males / Females: 8 / 16

Patients completing: 24, 4 men dropped out

Diseases: bulging disc 9, postlaminectomy 7, spinal stenosis 5, spondylothesis 1

Interventions Group 1: placebo, modified TENS unit, sham stimulation

Group 2: TENS

Group 3: NMES

Group 4: Combined NMES / TENS

TENS device characteristics: Amplitude: 0-60, Pulse with: 100

Pulse frequency: 100

Stimulation mode: conventional

Electrode placement: over the back where pain was most intense

Total number of electrodes: 4

NMES: 5 sec on, 15 sec off, pulse width: 200ms, frequency: 70 Hz, Amplitude: 0-100 mA

Treated time per session: 5 consecutives hours / day for 2 consecutive days with 2 days hiatus

Outcomes Present pain intensity scale

VAS-R

Pain relief

Notes Quality: 3 (1,1,1)

Allocation concealment B

Characteristics of excluded studies

Study Reason for exclusion

Biedermann, 87 Inappropriate control groups

Cheng, 87 Not compared to placebo (acupuncture)

Ghoname, 99 No control group (percutaneous stimulation)

Hackett, 88 Electroacupuncture, not TENS

Hamza, 99 No appropriate control group (TENS vs. percutaneous stimulation)

Herman, 94 No appropriate control group (TENS + exercise vs. exercise)

Jeans, 79 Only 6 patients with LBP

Laitinen, 76 No appropriate control group (TENS vs. acupuncture)

Lehmann, 83 inpatients

Lundeberg, 84 Only myalgia patients

13Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Characteristics of excluded studies (Continued )

Macdonald, 95 Superficial acupuncture

Melzack, 80 No appropriate control group (TENS vs. ice massage)

Melzack, 83 No appropriate control group (TENS vs. massage)

Schuster, 80 inpatients

Sternbach, 76 Not randomized

Stonnington, 76 No appropriate control group (TENS vs.)

Thorsteinsson, 78 Could not separate LBP patients from other diagnoses.

A D D I T I O N A L T A B L E S

Table 01. Clinical Relevance

Study

Treatment

Group

Oucome,

Scale # of pt.’s

Baseline

Mean

End of Study

Mean

Absolute

Difference

Absolute

Difference%

Deyo 90 TENS Pain, VAS 65 39.9 21.7 -4.30 -11%

Placebo 60 37.9 24.0

Gemignagi 91 TENS Pain, VAS 10 57.1 35.6 -15.80 -38%

Placebo 10 47.6 41.9

Marchand 93 TENS Pain, VAS 14 33 13.3 -12.10 -37%

Placebo 12 32 24.4

G R A P H S

Comparison 01. TENS vs Placebo, end of treatment (2 days)

Outcome titleNo. of

studies

No. of

participants Statistical method Effect size

01 Pain, continuous, patient-

assessed

Weighted Mean Difference (Fixed) 95% CI Subtotals only

Comparison 02. TENS vs Placebo, end of treatment (approx 1 month)

Outcome titleNo. of

studies

No. of

participants Statistical method Effect size

01 Pain, continuous, patient-

assessed

Weighted Mean Difference (Fixed) 95% CI Subtotals only

02 Pain Improvement, VAS

(0-100)

1 125 Weighted Mean Difference (Fixed) 95% CI 5.20 [-6.55, 16.95]

03 Pain frequency (1 - 5, 1 = never,

5 = all the time)

1 125 Weighted Mean Difference (Fixed) 95% CI -0.10 [-0.50, 0.30]

04 Stiffness (VAS) 1 20 Weighted Mean Difference (Fixed) 95% CI -12.00 [-26.96,

2.96]

05 Flexion ROM 3 417 Weighted Mean Difference (Fixed) 95% CI 0.10 [-0.27, 0.46]

06 Extension (degrees) 1 167 Weighted Mean Difference (Fixed) 95% CI 1.80 [-0.28, 3.88]

07 Function (Change from

baseline)

2 292 Weighted Mean Difference (Fixed) 95% CI -0.18 [-1.39, 1.03]

08 Self-Rated Activity Level 2 292 Weighted Mean Difference (Fixed) 95% CI 0.00 [-0.20, 0.20]

14Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

09 Use of services 2 250 Weighted Mean Difference (Fixed) 95% CI -0.08 [-0.22, 0.06]

10 Patient Satisfaction 1 128 Odds Ratio (Fixed) 95% CI 0.71 [0.35, 1.45]

11 McGill Work 1 167 Weighted Mean Difference (Fixed) 95% CI -1.00 [-3.23, 1.23]

12 Lasegue’s SLR (degrees) 1 125 Weighted Mean Difference (Fixed) 95% CI 0.00 [-2.70, 2.70]

13 SLR (degrees) 2 334 Weighted Mean Difference (Fixed) 95% CI 0.80 [-2.84, 4.44]

Comparison 03. TENS vs Placebo, Follow up (3 months)

Outcome titleNo. of

studies

No. of

participants Statistical method Effect size

01 Pain, continuous, patient-

assessed

Weighted Mean Difference (Fixed) 95% CI Subtotals only

Comparison 04. TENS vs Placebo, Follow up (6 months)

Outcome titleNo. of

studies

No. of

participants Statistical method Effect size

01 Pain, continuous, patient-

assessed

Weighted Mean Difference (Fixed) 95% CI Subtotals only

Comparison 05. TENS- High Quality vs. Low Quality, End of Treatment (1 month)

Outcome titleNo. of

studies

No. of

participants Statistical method Effect size

01 Pain, continuous, patient

assessed

3 171 Weighted Mean Difference (Fixed) 95% CI -4.32 [-10.36, 1.72]

02 Disability 2 292 Weighted Mean Difference (Fixed) 95% CI -0.18 [-1.39, 1.03]

I N D E X T E R M S

Medical Subject Headings (MeSH)

Chronic Disease; Low Back Pain [∗therapy]; Randomized Controlled Trials; ∗Transcutaneous Electric Nerve Stimulation

MeSH check words

Humans

C O V E R S H E E T

Title Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Authors Milne S, Welch V, Brosseau L, Saginur M, Shea B, Tugwell P, Wells G

Contribution of author(s) Sarah Milne, Michael Saginur, Bev Shea, Vivian Welch selected trials and extracted data.

Sarah Milne, Lucie Brosseau and Vivian Welch are responsible for the results and interpre-

tation of data.

George Wells provided statistical consultation.

Peter Tugwell was involved in the clinical interpretation of results.

Issue protocol first published 1998/1

Review first published 2001/2

Date of most recent amendment 23 February 2005

Date of most recent

SUBSTANTIVE amendment

03 August 2000

15Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

What’s New Information not supplied by author

Date new studies sought but

none found

Information not supplied by author

Date new studies found but not

yet included/excluded

Information not supplied by author

Date new studies found and

included/excluded

30 June 2000

Date authors’ conclusions

section amended

Information not supplied by author

DOI 10.1002/14651858.CD003008

Cochrane Library number CD003008

Editorial group Cochrane Back Group

Editorial group code HM-BACK

G R A P H S A N D O T H E R T A B L E S

Comparison 05. 01 Pain, continuous, patient-assessed

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 01 TENS vs Placebo, end of treatment (2 days)

Outcome: 01 Pain, continuous, patient-assessed

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

01 relief

Moore, 97 24 40.58 (27.55) 24 44.81 (30.67) 100.0 -4.23 [ -20.72, 12.26 ]

Subtotal (95% CI) 24 24 100.0 -4.23 [ -20.72, 12.26 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.50 p=0.6

02 mean reduction in intensity, VAS

Moore, 97 24 -5.55 (5.78) 24 -5.83 (7.48) 100.0 0.28 [ -3.50, 4.06 ]

Subtotal (95% CI) 24 24 100.0 0.28 [ -3.50, 4.06 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.15 p=0.9

04 McGill Pain Questionnaire: Present Pain Intensity *

Moore, 97 24 2.27 (1.13) 24 2.42 (1.15) 100.0 -0.15 [ -0.80, 0.50 ]

Subtotal (95% CI) 24 24 100.0 -0.15 [ -0.80, 0.50 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.46 p=0.6

-10.0 -5.0 0 5.0 10.0

Favours Treatment Favours Control

16Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Comparison 05. 01 Pain, continuous, patient-assessed

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 01 Pain, continuous, patient-assessed

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

01 VAS (0-100)

Deyo, 90a 65 21.70 (20.66) 60 24.00 (20.66) 69.5 -2.30 [ -9.55, 4.95 ]

Gemignani, 91 10 35.60 (20.50) 10 41.90 (16.30) 13.9 -6.30 [ -22.53, 9.93 ]

Marchand, 93 14 13.30 (8.30) 12 24.40 (25.00) 16.7 -11.10 [ -25.90, 3.70 ]

Subtotal (95% CI) 89 82 100.0 -4.32 [ -10.36, 1.72 ]

Test for heterogeneity chi-square=1.16 df=2 p=0.56 I =0.0%

Test for overall effect z=1.40 p=0.2

02 Unpleasantness

Marchand, 93 14 11.11 (8.35) 12 22.20 (23.00) 100.0 -11.09 [ -24.82, 2.64 ]

Subtotal (95% CI) 14 12 100.0 -11.09 [ -24.82, 2.64 ]

Test for heterogeneity: not applicable

Test for overall effect z=1.58 p=0.1

03 Self-rated improvent (1-6)

Deyo, 90a 65 2.90 (1.04) 60 2.90 (1.04) 100.0 0.00 [ -0.36, 0.36 ]

Subtotal (95% CI) 65 60 100.0 0.00 [ -0.36, 0.36 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.00 p=1

-10.0 -5.0 0 5.0 10.0

Favours Treatment Favours Control

Comparison 05. 02 Pain Improvement, VAS (0-100)

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 02 Pain Improvement, VAS (0-100)

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

Deyo, 90a 65 47.00 (33.49) 60 41.80 (33.49) 100.0 5.20 [ -6.55, 16.95 ]

Total (95% CI) 65 60 100.0 5.20 [ -6.55, 16.95 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.87 p=0.4

-10.0 -5.0 0 5.0 10.0

Favours Treatment Favours Control

17Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Comparison 05. 03 Pain frequency (1 - 5, 1 = never, 5 = all the time)

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 03 Pain frequency (1 - 5, 1 = never, 5 = all the time)

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

Deyo, 90a 65 2.90 (1.14) 60 3.00 (1.14) 100.0 -0.10 [ -0.50, 0.30 ]

Total (95% CI) 65 60 100.0 -0.10 [ -0.50, 0.30 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.49 p=0.6

-10.0 -5.0 0 5.0 10.0

Favours Control Favours Treatment

Comparison 05. 04 Stiffness (VAS)

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 04 Stiffness (VAS)

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

01 VAS

Gemignani, 91 10 31.00 (19.30) 10 43.00 (14.50) 100.0 -12.00 [ -26.96, 2.96 ]

Total (95% CI) 10 10 100.0 -12.00 [ -26.96, 2.96 ]

Test for heterogeneity: not applicable

Test for overall effect z=1.57 p=0.1

-10.0 -5.0 0 5.0 10.0

Favours Control Favours Treatment

18Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Comparison 05. 05 Flexion ROM

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 05 Flexion ROM

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

01 finger-to-floor

Deyo, 90a 65 8.70 (7.27) 60 8.70 (7.27) 2.0 0.00 [ -2.55, 2.55 ]

Subtotal (95% CI) 65 60 2.0 0.00 [ -2.55, 2.55 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.00 p=1

02 Schober test (cm)

Deyo, 90a 65 4.20 (1.05) 60 4.10 (1.05) 97.6 0.10 [ -0.27, 0.47 ]

Subtotal (95% CI) 65 60 97.6 0.10 [ -0.27, 0.47 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.53 p=0.6

03 degrees

Jarzem, 97 84 3.00 (19.20) 83 3.30 (19.10) 0.4 -0.30 [ -6.11, 5.51 ]

Subtotal (95% CI) 84 83 0.4 -0.30 [ -6.11, 5.51 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.10 p=0.9

Total (95% CI) 214 203 100.0 0.10 [ -0.27, 0.46 ]

Test for heterogeneity chi-square=0.02 df=2 p=0.99 I =0.0%

Test for overall effect z=0.52 p=0.6

-10.0 -5.0 0 5.0 10.0

Favours Control Favours Treatment

Comparison 05. 06 Extension (degrees)

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 06 Extension (degrees)

Study TENS Placebo Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

Jarzem, 97 84 2.40 (7.30) 83 0.60 (6.40) 100.0 1.80 [ -0.28, 3.88 ]

Total (95% CI) 84 83 100.0 1.80 [ -0.28, 3.88 ]

Test for heterogeneity: not applicable

Test for overall effect z=1.69 p=0.09

-10.0 -5.0 0 5.0 10.0

19Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Comparison 05. 07 Function (Change from baseline)

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 07 Function (Change from baseline)

Study treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

01 Scales (SIP % Roland Disability)

Deyo, 90a 65 -5.70 (4.99) 60 -6.20 (4.99) 47.6 0.50 [ -1.25, 2.25 ]

Jarzem, 97 84 -1.40 (5.50) 83 -0.60 (5.50) 52.4 -0.80 [ -2.47, 0.87 ]

Total (95% CI) 149 143 100.0 -0.18 [ -1.39, 1.03 ]

Test for heterogeneity chi-square=1.11 df=1 p=0.29 I =9.9%

Test for overall effect z=0.29 p=0.8

-10.0 -5.0 0 5.0 10.0

Favours Treatment Favours Control

Comparison 05. 08 Self-Rated Activity Level

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 08 Self-Rated Activity Level

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

03 Scale (SIP Activity Level, McGill Activity)

Deyo, 90a 65 1.70 (0.57) 60 1.70 (0.57) 99.9 0.00 [ -0.20, 0.20 ]

Jarzem, 97 84 5.80 (22.90) 83 2.20 (21.00) 0.1 3.60 [ -3.06, 10.26 ]

Total (95% CI) 149 143 100.0 0.00 [ -0.20, 0.20 ]

Test for heterogeneity chi-square=1.12 df=1 p=0.29 I =10.8%

Test for overall effect z=0.03 p=1

-10.0 -5.0 0 5.0 10.0

Favours Control Favours Treatment

20Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Comparison 05. 09 Use of services

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 09 Use of services

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

01 days in hospital

x Deyo, 90a 65 0.00 (0.00) 60 0.00 (0.00) 0.0 Not estimable

Subtotal (95% CI) 65 60 0.0 Not estimable

Test for heterogeneity: not applicable

Test for overall effect: not applicable

02 visits to other providers

Deyo, 90a 65 0.22 (0.40) 60 0.30 (0.40) 100.0 -0.08 [ -0.22, 0.06 ]

Subtotal (95% CI) 65 60 100.0 -0.08 [ -0.22, 0.06 ]

Test for heterogeneity: not applicable

Test for overall effect z=1.12 p=0.3

Total (95% CI) 130 120 100.0 -0.08 [ -0.22, 0.06 ]

Test for heterogeneity: not applicable

Test for overall effect z=1.12 p=0.3

-10.0 -5.0 0 5.0 10.0

Favours Control Favours Treatment

Comparison 05. 10 Patient Satisfaction

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 10 Patient Satisfaction

Study Treatment Control Odds Ratio (Fixed) Weight Odds Ratio (Fixed)

n/N n/N 95% CI (%) 95% CI

Deyo, 90a 34/60 44/68 100.0 0.71 [ 0.35, 1.45 ]

Total (95% CI) 60 68 100.0 0.71 [ 0.35, 1.45 ]

Total events: 34 (Treatment), 44 (Control)

Test for heterogeneity: not applicable

Test for overall effect z=0.93 p=0.4

0.1 0.2 0.5 1 2 5 10

Favours treatment Favours control

21Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Comparison 05. 11 McGill Work

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 11 McGill Work

Study Tens Placebo Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

Jarzem, 97 84 -0.90 (8.20) 83 0.10 (6.40) 100.0 -1.00 [ -3.23, 1.23 ]

Total (95% CI) 84 83 100.0 -1.00 [ -3.23, 1.23 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.88 p=0.4

-10.0 -5.0 0 5.0 10.0

Comparison 05. 12 Lasegue’s SLR (degrees)

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 12 Lasegue’s SLR (degrees)

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

Deyo, 90a 65 84.00 (7.69) 60 84.00 (7.69) 100.0 0.00 [ -2.70, 2.70 ]

Total (95% CI) 65 60 100.0 0.00 [ -2.70, 2.70 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.00 p=1

-10.0 -5.0 0 5.0 10.0

Favours Control Favours Treatment

22Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Comparison 05. 13 SLR (degrees)

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 02 TENS vs Placebo, end of treatment (approx 1 month)

Outcome: 13 SLR (degrees)

Study TENS Placebo Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

01 Right leg

Jarzem, 97 84 -0.30 (17.40) 83 -1.50 (16.40) 50.4 1.20 [ -3.93, 6.33 ]

Subtotal (95% CI) 84 83 50.4 1.20 [ -3.93, 6.33 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.46 p=0.6

02 Left leg

Jarzem, 97 84 -0.90 (19.20) 83 -1.30 (14.60) 49.6 0.40 [ -4.77, 5.57 ]

Subtotal (95% CI) 84 83 49.6 0.40 [ -4.77, 5.57 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.15 p=0.9

Total (95% CI) 168 166 100.0 0.80 [ -2.84, 4.44 ]

Test for heterogeneity chi-square=0.05 df=1 p=0.83 I =0.0%

Test for overall effect z=0.43 p=0.7

-10.0 -5.0 0 5.0 10.0

Comparison 05. 01 Pain, continuous, patient-assessed

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 03 TENS vs Placebo, Follow up (3 months)

Outcome: 01 Pain, continuous, patient-assessed

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

01 VAS (0-100)

Marchand, 93 14 21.40 (26.70) 12 25.70 (24.70) 100.0 -4.30 [ -24.07, 15.47 ]

Subtotal (95% CI) 14 12 100.0 -4.30 [ -24.07, 15.47 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.43 p=0.7

02 Unpleasantness

Marchand, 93 14 20.00 (26.70) 12 21.40 (24.70) 100.0 -1.40 [ -21.17, 18.37 ]

Subtotal (95% CI) 14 12 100.0 -1.40 [ -21.17, 18.37 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.14 p=0.9

-10.0 -5.0 0 5.0 10.0

Favours Treatment Favours Control

23Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Comparison 05. 01 Pain, continuous, patient-assessed

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 04 TENS vs Placebo, Follow up (6 months)

Outcome: 01 Pain, continuous, patient-assessed

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

01 VAS (0-100)

Marchand, 93 14 15.70 (24.00) 12 24.20 (22.30) 100.0 -8.50 [ -26.31, 9.31 ]

Subtotal (95% CI) 14 12 100.0 -8.50 [ -26.31, 9.31 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.94 p=0.3

02 Unpleasantness

Marchand, 93 14 14.30 (24.00) 12 22.10 (22.30) 100.0 -7.80 [ -25.61, 10.01 ]

Subtotal (95% CI) 14 12 100.0 -7.80 [ -25.61, 10.01 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.86 p=0.4

-10.0 -5.0 0 5.0 10.0

Favours Treatment Favours Control

Comparison 05. 01 Pain, continuous, patient assessed

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 05 TENS- High Quality vs. Low Quality, End of Treatment (1 month)

Outcome: 01 Pain, continuous, patient assessed

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

01 High Quality (>2, median quality)

Deyo, 90a 65 21.70 (20.66) 60 24.00 (20.66) 69.5 -2.30 [ -9.55, 4.95 ]

Subtotal (95% CI) 65 60 69.5 -2.30 [ -9.55, 4.95 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.62 p=0.5

02 Low Quality (2 or less)

Gemignani, 91 10 35.60 (20.50) 10 41.90 (16.30) 13.9 -6.30 [ -22.53, 9.93 ]

Marchand, 93 14 13.30 (8.30) 12 24.40 (25.00) 16.7 -11.10 [ -25.90, 3.70 ]

Subtotal (95% CI) 24 22 30.5 -8.92 [ -19.86, 2.01 ]

Test for heterogeneity chi-square=0.18 df=1 p=0.67 I =0.0%

Test for overall effect z=1.60 p=0.1

Total (95% CI) 89 82 100.0 -4.32 [ -10.36, 1.72 ]

Test for heterogeneity chi-square=1.16 df=2 p=0.56 I =0.0%

Test for overall effect z=1.40 p=0.2

-10.0 -5.0 0 5.0 10.0

Favours treatment Favours control

24Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd

Comparison 05. 02 Disability

Review: Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain

Comparison: 05 TENS- High Quality vs. Low Quality, End of Treatment (1 month)

Outcome: 02 Disability

Study Treatment Control Weighted Mean Difference (Fixed) Weight Weighted Mean Difference (Fixed)

N Mean(SD) N Mean(SD) 95% CI (%) 95% CI

01 High Quality (>2, median quality)

Deyo, 90a 65 -5.70 (4.99) 60 -6.20 (4.99) 47.6 0.50 [ -1.25, 2.25 ]

Subtotal (95% CI) 65 60 47.6 0.50 [ -1.25, 2.25 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.56 p=0.6

02 Low Quality (2 or less)

Jarzem, 97 84 -1.40 (5.50) 83 -0.60 (5.50) 52.4 -0.80 [ -2.47, 0.87 ]

Subtotal (95% CI) 84 83 52.4 -0.80 [ -2.47, 0.87 ]

Test for heterogeneity: not applicable

Test for overall effect z=0.94 p=0.3

Total (95% CI) 149 143 100.0 -0.18 [ -1.39, 1.03 ]

Test for heterogeneity chi-square=1.11 df=1 p=0.29 I =9.9%

Test for overall effect z=0.29 p=0.8

-10.0 -5.0 0 5.0 10.0

Favours treatment Favours control

25Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain (Review)

Copyright © 2005 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd