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Journal of Musculoskeletal Pain

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Transcutaneous Electrical Nerve Stimulation [TENS] for

Short-Term Treatment of Low Back Pain–Randomized
Double Blind Crossover Study of Sham versus
Conventional TENS
a b c d
Peter F. Jarzem , Edward J. Harvey , Nicholas Arcaro & Janusz Kaczorowski
a
Department of Orthopaedic Surgery, Santa Cabrini Hospital, and Montreal Back Institute,
Montreal, Canada
b
McGill University Health Center, Montreal General Hospital, Department of Orthopaedic
Surgery, Montreal, Canada
c
Montreal Back Institute, Montreal, Canada
d
Department of Family Medicine, McMaster University, Hamilton, Canada
Published online: 15 May 2015.

To cite this article: Peter F. Jarzem, Edward J. Harvey, Nicholas Arcaro & Janusz Kaczorowski (2005) Transcutaneous
Electrical Nerve Stimulation [TENS] for Short-Term Treatment of Low Back Pain–Randomized Double Blind Crossover Study of
Sham versus Conventional TENS, Journal of Musculoskeletal Pain, 13:2, 11-17

To link to this article: http://dx.doi.org/10.1300/J094v13n02_03

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 Transcutaneous Electrical Nerve Stimulation [TENS]
for Short-Term Treatment of Low Back Pain–
Randomized Double Blind Crossover Study
of Sham versus Conventional TENS
Peter F. Jarzem
Edward J. Harvey
Nicholas Arcaro
Janusz Kaczorowski
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ABSTRACT. The objective of this study was to compare conventional transcutaneous electrical
nerve stimulation [TENS] with sham therapy using a randomized double blind crossover design.
The subjects of the study were patients with chronic low back pain without sciatica seen in an out-
patient clinic. Patients were randomized to receive either conventional TENS, or sham TENS,
which was then followed by two treatments of the other modality. The physician, patient, and treat-
ing therapist were blinded to the order of treatment. Pain tolerance was measured with a visual ana-
log scale rating from no pain to worst pain. Physical measurements included flexion, extension,
straight leg raising, isolift score, back extensions, sit-ups, oblique sit-ups, and side flexion. There
was a significant improvement for the conventional TENS in both the objective outcomes and
functional measurements. The conclusion is that TENS therapy significantly reduces pain and im-
proves performance on the majority of standardized tests of physical capacity. Transcutaneous
electrical nerve stimulation should be considered in the situation where short-term pain relief is de-
sired. [Article copies available for a fee from The Haworth Document Delivery Service: 1-800-HAWORTH.
E-mail address: <docdelivery@haworthpress.com> Website: <http://www.HaworthPress.com>  2005 by
The Haworth Press, Inc. All rights reserved.]

KEYWORDS. Transcutaneous electrical nerve stimulation, randomized double blind study, low
back pain, rehabilitation

Peter F. Jarzem, MD, FRCSC, is affiliated with the Department of Orthopaedic Surgery, Santa Cabrini Hospital,
and Montreal Back Institute, Montreal, Canada.
Edward J. Harvey, MD, MSc, FRCSC, is affiliated with McGill University Health Center, Department of Ortho-
paedic Surgery, Montreal General Hospital, Montreal, Canada.
Nicholas Arcaro, BSc, is affiliated with Montreal Back Institute, Montreal, Canada.
Janusz Kaczorowski, PhD, is affiliated with the Department of Family Medicine, McMaster University, Hamil-
ton, Canada.
Address correspondence to: Edward J. Harvey, MDCM, MSc, Montreal General Hospital, McGill University
Health Center, Department of Orthopaedic Surgery, 1650 Cedar Avenue, Room B5.159.5, Montreal, Quebec, Can-
ada H3G 1A4 [E-mail: ejharvey@hotmail.com].
The authors have not received financial support for the completion of this project.
Submitted: August 25, 2003.
Revision accepted: February 4, 2004.
Journal of Musculoskeletal Pain, Vol. 13(2) 2005
Available online at http://www.haworthpress.com/web/JMP
 2005 by The Haworth Press, Inc. All rights reserved.
doi:10.1300/J094v13n02_03 11
 12 JOURNAL OF MUSCULOSKELETAL PAIN
INTRODUCTION
In the United States low back pain had been
estimated to be a $13 billion dollar expense in
1981 (1). Two decades later the costs for low
back pain are only increasing. Lumbar spine in-
juries account for 70 percent of all spine related
work disorders. Spinal disorders comprise up
to 14 percent of all workman’s compensation
claims in some studies (2). This rate of compen-
sation is constant for all western countries and
is rising at a rate that is disproportionate to the
increase in the population (3). Dozens of differ-
ent therapies are used for lower back pain but
very few treatment modalities have been rigor-
ously studied (4).
Transcutaneous electrical nerve stimulation
[TENS] has been in use for three decades for the
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treatment of pain. Transcutaneous electrical
nerve stimulation therapy is based on the gate
control theory of pain (5). Theoretically, al-
tered stimulationof the nervous system through
transcutaneous electrodes modifies the percep-
tion of pain. Several studies have evaluated the
efficacy of TENS on diminishment of lower
back pain (1,4,6-9). The clinical relevance of
most studies is difficult to ascertain due to study
design or size of the sample. Many studies have
been non-randomized or without a control group
(10-13). Most randomized control studies have
produced no conclusive evidence that TENS
therapy is beneficial (4,14). A large study with
conventional, nu-waveform and acupuncture-
type TENS as compared to sham treatment has
been performed at our institution (15). In that
study over a four week period, comparing the
efficacy of these four modalities for chronic
back pain relief, sham therapy was as effective
as the other modalities.
Transcutaneous electrical nerve stimulation
as a treatment for short-term pain relief has yet to
be clarified (11). The use of TENS for the period
of physiotherapy in rehabilitation could be bene-
ficial for ensuring progress in range of motion
and strengthening. A significant criticism of
TENS sham studies is that placebo TENS may
be a particularly effective placebo treatment. To
prevent unfair comparisons, each patient in this
study was treated with both TENS and a placebo
in a crossover design trial. Crossover studies are
often criticized for introducing bias based on the
sequence order of the treatments. This carryover
bias can be isolated mathematically by perform-
ingadoublesequencestudytodeterminethetrue
effects of the treatment.
METHODS
Selection of Patients
All patients with low back pain [LBP], with-
out leg symptoms, from a single physicians
practice [P.J.] were invited to join the study.
The practice profile was a mixed referral pat-
tern with referrals from primary care givers and
surgeons. The patients were from a surgeon’s
practice. The patients were only included if
they met the following inclusion criteria: con-
tinuous LBP for at least three months; age be-
tween 18 and 70; able to make the required vis-
its over the treatment period. The patients were
excluded if they had any of the following exclu-
sion criteria: maximal pain above T12; previous
use of TENS; patient currently seeking to ob-
tain disability compensation; history of cancer,
corticosteroid or anticoagulation use; implanted
pacemaker; sciatica; concomitant physiother-
apy or chiropractic therapy; recent surgery
[previous three months]; onset of major illness;
pregnancy.
Treatment Assignment
Patients were randomized upon enrollment
in this study using a random number table into a
crossover study of two treatment types. The
two treatment types were conventional TENS
and sham TENS. The patients were assigned to
the either receive conventional TENS followed
by two treatments of sham TENS [CSS], or
sham TENS followed by two treatments of con-
ventional therapy [SCC], in a consecutive fash-
ion, depending on the order of enrollment.
The treatment was instigated at the first visit.
Each patient received three treatment periods.
Each treatment was twenty minutes in duration.
The TENS machine was changed after each of
three treatments even though the consecutive
treatments may have been identical. After each
treatment the patient was evaluated with a vi-
sual analog scale [VAS] score and physical pa-
rameter evaluation. Treatment protocol was
approved by an ethical review board.
 Jarzem et al.
Treatment
The two treatment groups received identical
appearing TENS stimulators. The sham stimu-
lators had indicator lights to mimic operation.
The machines were set, for each individual pa-
tient, at the threshold level just below the inten-
sity that caused muscle twitching. The sham pa-
tients had an adjustment of their intensity dial.
All patients were instructed that some patients
felt the TENS while others did not. The elec-
trode placement for each patient was optimized
as per the manufacturer instructions and the
individual needs.
Follow-Up, Assessment of Outcome,
and Blinding
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The patients were seen for initial evaluation
to determine if they were candidates for the
study. If entered in the study, they were given
treatment at that same clinic visit. They re-
ceived sham therapy and SCC or conventional
TENS and CSS. At the first visit, the baseline
status of the patient was gathered by question-
naire and personal interview. Information was
gathered for: age, sex, race, weight, height, oc-
cupation, occupational stressors, job satisfac-
tion, employment status, education, marital
status, family status, use of tobacco, alcohol
consumption, medications, duration of LBP,
severity and distribution of LBP, periodicity of
low back pain, past psychiatric, surgical, and
medical history, mechanism of onset of LBP,
and previous investigative procedures.
Measures of outcome included both func-
tional and physical measures. These measure-
ments were made within a short period after the
treatments [usually within the hour]. Pain toler-
ance was measured with a visual analog scale
rating from no pain to worst pain. Physical mea-
surements included flexion, extension, straight
leg raising, isolift score, back extensions, sit-
ups, oblique sit-ups, and side flexion. Flexion
and extension were measured using a spirit
level, or gravity goniometer, positioned at L4-5.
This device is a circular trough of water with
gradations in degrees. Differences in motion
are easily and reproducibly evaluated. Straight
leg raising was measured in degrees of inclina-
tion from the table. Bilateral straight leg raising
was measured as the ability to maintain both
13
legs three inches from the table in the supine po-
sition for at least five seconds. Isolift scoring is
a value given by an isometric dead lift device.
For the back extensions, side flexions and
sit-ups the quantity performed without undue
pain was recorded.
These objective physical measurements were
recorded by a single blinded observer who was
a trained physiotherapist, and was the TENS
technician responsible for the initial adjust-
ment of the device or administration of treat-
ment. Lead placement was optimized as per the
manufacturer instructions. Lead placement was
also adjusted according to the patient’s prefer-
ence for individual efficacy. Intensity was ad-
justed to the threshold point below noxious
stimulation in accordance with the recommen-
dations of the manufacturer. The patient could
adjust subsequent stimulation levels.
Statistical Analysis
Differences in demographics and illness vari-
ables between the two groups were analyzed
with chi-squared statistics for dichotomous and
categorical variables and categorical variables
and t-tests for continuous variables. Where ap-
plicable, non-parametric one-way analysis of
variance was used. Comparison of the two
groups was carried out by means of LSMEANS
t-test. All analyses were carried out by using a
variation of the ANOVA procedure called the
general linear models procedure in SAS.
Analysis of the results allowed an examina-
tion of the following effects: treatment, carry-
over, period, and sequence. Treatment effect is
the effect of the treatment on the outcome. The
carryover effect is that a previous treatment has
affected the outcome. The test compared differ-
ential carryover effects between treatment with
sham or conventional therapy. Whenever this
test is significant it means that for one of the
treatments the preceding scores from treatment
have influenced the subsequent scores. Period
effect was analyzed for difference between
treatments for the period at which they occurred
[1 versus 2, 2 versus 3, 1 versus 3]. Generally
speaking, there is no valid test for period differ-
ences when the period is modeled as a quantita-
tive variable, as in this study. The type II period
sum of squares is always spurious in designs in
which carryover effects are being estimated,
 14 JOURNAL OF MUSCULOSKELETAL PAIN

due to the irresolvable confounding of carry- TABLE 1. Characteristics and Comparability of

over with the first period effects. However Treatment Groups
when carryover effects prove to be non-signifi-
Characteristic SCC CSS All subjects
cant, it is possible to use the type I sum of
Number 25 25 50
squares to produce a statistical test that is only
Mean Age [SD] 38.4 [12.1] 39.5 [16.8] 38.9 [14.5]
slightly inexact. Sequence effect refers to dif-
Sex [% Female] 10 [40] 11 [44] 21 [42]
ferences in scores depending on the order of Education [% college] 12 [48] 12 [48] 24 [48]
treatment [SCC versus CSS]. The examination Married [%] * 8 [32] 14 [56] 22 [44]
of sequence effect, although included, is not as Weight lbs. [SD] 158.8 [37.6] 149.7 [27.7] 154.3 [33.0]
rigorous because of the inexact testing for Height in [SD] 67.9 [3.1] 67.7 [3.3] 67.8 [3.2]
treatment differences or differences actually Children [%] 48 44 46
due to the sequence of the treatment. Activities [% none] 12 36 24
Enjoy Job [% never] 0 4 2
Job Stress [% never] 20 20 20
RESULTS Heavy Labor [%] 20 16 18
Smoking [%] 36 32 34
Fifty eligible patients were selected which Years Smoking [mean] 6.8 8.9 7.9

met the inclusion and exclusion criteria. All

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Loss of Weight [%] 0 0 0

fifty eligible patients completed the study [100 Shoe Lift [%] 8 0 4
Back Surgery [%] 4 4 4
percent compliance]. Twenty-five patients were
Pain Medication [%] 20 12 16
in each of the study groups. The comparable de-
History Back Problems [%] 88 84 86
mographic characteristics for each group and
Age at 1st Back Pain [SD] 28.5 [10.1] 31.7 [14.1] 30.1 [12.2]
the overall population are demonstrated in
Mean Pain Duration [years] 9.8 7.8 8.8
Table 1. Compensation [%] 0 4 2
The groups of patients divided between the Psychiatric History [%] 8 8 8
two treatment groups were not significantly GI History [%] 12 32 22
different except for the proportion of married or VAS Score [SD] 40.9 [19.3] 43 [17.5] 42 [18.3]
common law marriages [P < 0.05]. Mean Roland Score [SD] 5.8 [2.8] 6.6 [3.1] 6.2 [3.0]
The actual outcome measurements amongst Ordinal Pain Score [%]
the study groups as compared for each effect are Little 16 12 14
illustrated in Table 2. Each treatment outcome Moderate 68 76 72
was analyzed separately. The VAS score dem- Very Bad 16 12 14
onstrated a significant treatment effect [P = This table illustrates the basic demographic profile of the two study groups,
as well as a comparison to the overall average.
0.0001]. There is also a significant carryover
SCC = Sham, Conventional, Conventional Therapy, CSS = Conventional,
effect [P < 0.05] from one period to the next, Sham, Sham Therapy
with conventional TENS having a greater ef- % = percent, SD = standard deviation
* = Significant difference; P < 0.05
fect than the sham TENS. Period effects could
not be measured for the VAS. Sequence effect
analysis revealed no significant effect related to [P = 0.0093]. There was not a significant carry-
the groups. over or period effect. Improvements occurred
Treatment with conventional TENS improved when conventional TENS was used.
forward flexion [P = 0.0001]. Carryover effects Right straight leg was significantly effected
are significant for conventional TENS treat- by conventional TENS [P = 0.008]. There was
ment [P = 0.0029]. Period effects cannot be
clearly estimated. Sequence effects demon- no significant carryover effect. Sequence ef-
strate a significant difference between the treat- fects are significantly different [P = 0.0001].
ments [P = 0.0021]. Some of this may be due to There was no significant difference for left
difficulty with blinding of the patient between straight leg raising, although there was a trend
the two treatments. Flexion continued to im- for TENS to be superior treatment[P = 0.0932].
prove as long as conventional TENS treatment Patients with conventional therapy were able
was being utilized. Extension is also signifi- to lift significantly more weight on the isolift
cantly affected by conventional TENS therapy machine [P = 0.0001], perform more back
 Jarzem et al. 15

TABLE 2. Outcome Measurements of TENS Ther- tation period was the impetus for this study. The
apy [Comparison of Effects by Crossover Trial] current study diminishes the bias of placebo
therapy because every subject receives both
Measure Sequence Carryover Period Treatment
[P value] [P value] [P value]
conventional TENS therapy and sham therapy
VAS NS S NM S
in a sequential manner. The carryover and treat-
[.9829] [.0012] [.0001] ment effects can be isolated mathematically al-
Flexion S
[.0021]
S
[.0029]
NM S
[.0001]
lowing an evaluation of which treatment was
Extension S NS NS S
more efficacious for each patient.
[.0001] [.4814] [.5492] [.0093] The study design implemented in this trial
Right SLR S NS S S provides an opportunity to determine with pre-
[.0001] [.5922] [.0001] [.008]
S NS S
cision the magnitude of the treatment effects
Left SLR T
[.0001] [.6525] [.001] [.0932] compared with the carryover, period, and se-
Isolift S NS S S quence effects found in crossover study de-
[.0001] [.4023] [.0001] [.0001]
signs. The advantage is that each of these ef-
Back Ext. S S NM S
[.0001] [.0158] [.0001] fects can be treated as separate mathematical
Sit-Ups S NS S S entities. The main disadvantage is that this type
[.0001] [.2836] [.0309] [.001] of analysis introduces more complexity to the
Side Flexion S NS NS S
design and implementation of the study. Due to
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[.0001] [.0782] [.8768] [.0001]

Oblique S NS NS S the short period of treatment in this study the
Sit-Ups [.0001] [.3692] [.0829] [.0001]
This table illustrates the statistical outcomes for each measured outcome
score. Sequence and carryover effects have been tabulated but the overall
treatment significance is on the right column with the attendant
NS: not significant; P > 0.05
NM: not measurable
S: significant; P < 0.05
T: Trend to significance
extensions [P = 0.0001], side flexions [P =
0.0001], sit-ups [P = 0.001], and oblique sit-ups
[P = 0.0001].
DISCUSSION
Studies of TENS treatment in the past have
indicated that there is some effect of the TENS
therapy (6,8,10,11,13,16-19). Well-blinded tri-
als for other painful conditions (19, 20) have
suggested that TENS might not have a benefi-
cial effect for treatment of long periods. Deyo et
al. (1) among others have shown that placebo
treatment is as efficacious as TENS for chronic
low back pain. Other data from our group in a
similar double blind study with larger numbers
and appropriate therapy thresholds has rein-
forced that conclusion (15).
Implementation of TENS for the period of
physiotherapy in rehabilitation of chronic back
pain could be beneficial for ensuring progress
in range of motion and strengthening. The use
of the TENS unit as a reliable technique for
short-term pain relief during the acute rehabili-
added complexity was not a detriment. The iso-
lated effect of conventional TENS is tabulated
in Table 2. There was a significant treatment ef-
fect for TENS in every functional and objective
outcome in this study except for left straight leg
raising and this measure trended towards sig-
nificance [P = 0.0923]. The significant se-
quence effects are indistinguishable from the
significant treatment effect in the mathematical
context. Because of the random assignation of
treatment subjects [Table 1] it is generally as-
sumed that most of the contribution is from the
actual treatment. The carryover effect is gener-
ally not significant but addresses only if there is
a carryover effect from one treatment to the
other and does not address whether the two
treatments are different or efficacious. Most
period effect comparisons are not measurable
in this study because period is modeled as a
qualitative variable.
Potential bias in any study may influence the
outcome. In this study, there are many potential
sources of bias. Bias can result if the patients
have not received adequate therapy [perfor-
mance bias]. This study incorporated manufac-
turers recommendations for dosages with patient
control of the TENS unit. Patients receiving
conventional TENS treatment were able to per-
ceive that their TENS machines were working.
The sham TENS users were never able to per-
ceive that the TENS units were stimulating, al-
though they were told by the technician that the
machines were working.
 16 JOURNAL OF MUSCULOSKELETAL PAIN
There were no dropouts in the study because
of the design and therefore transfer bias was
minimized. Direct observation throughout the
study insured high compliance. Bias can result
from the inclusion of a large percentage of pa-
tients with reason for secondary gain or failure
of therapy [susceptibility bias]. There were no
ongoing compensation claims from any of
these patients. No patient had recent surgery for
their back pain and no patient had been chroni-
cally dependent on narcotics for pain relief.
Deyo et al. (21) noted that a potential source
of bias could be that the measures of outcome
may be too inexact to measure the effect of the
treatment [detection bias]. The measures im-
plemented in this study are those used to define
the disease and should not be a source of bias.
The broad range of measures used in this study
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included scales that have been validated and re-
ferred to in the literature in order to ensure the
comparability of this study with others.
There are theoretical weaknesses with this
study. Blinding was not assessed and it is possi-
ble that the tingling felt by the patients with
functioning units simply motivated them to
higher performance and persuaded them to be-
lieve in lower pain levels although no actual
physiologic pain relief effects were occurring.
Only one type of TENS stimulation was used in
this study. Other types exist and may be more
efficacious than the conventional type imple-
mented. Newer devices with claimed acceler-
ated injury repair capabilities should be ex-
plored with this same model. The population in
this study had a low Roland disability score on
inception. This may reflect a stoic patient popu-
lation or a lower disability group. Physical out-
come measurements resulted in significant dif-
ferences [Table2].Themovementmeasurement
differences only reflected single digit degree
changes and may have been within the mea-
surement unreliability. This was minimized by
a single measurer but may not reflect clinically
relevant changes. The number of situps did in-
crease by 10 percent, the isolift capacity in-
creased by 15 percent and the VAS had a 50 per
cent drop with TENS compared to sham ther-
apy. These probably do reflect a more clinically
relevant outcome change. This study shows
that TENS is effective over a one-hour period
while previous studies show that TENS is no
more effective than placebo over a longer pe-
riod. While the study design and outcome
measures have differed in our two (15) studies,
it appears that TENS may not be useful for the
long-term treatment of chronic low back pain,
but could be useful over shorter periods. More
work needs to be done to define the circum-
stances in which TENS offers effective treat-
ment.
In conclusion, TENS may be a useful therapy
for the short-term relief of chronic low back
pain. All functional and objective criteria were
improved with the use of TENS. Transcutan-
eous electricalnerve stimulation should be con-
sidered for the situation where short-term pain
relief is desired.
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