Pain, 11 (1981) 233--240 233

Elsevier/North-Holland Biomedical Press

TREATMENT OF OSTEOARTHRITIS OF THE KNEE WITH

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION

PHILIP TAYLOR l, MARK HALLETT 2,* and LORRAINE FLAHERTY 3

I Department o f Rheumatology and 2 Section o f Neurology, Brigham and Women's
Hospital; Departments o f I Medicine and 2 Neurology, Harvard Medical School, Boston,
Mass. 02115; 3 Veterans ' Administration Hospital, West Roxbury, Mass. 02132 (U.S.A.)
(Received 4 September 1980, accepted 26 March 1981)

SUMMARY

Ten patients with pain due to osteoarthritis of the knee were treated in a
double-blind cross-over study with two weeks of transcutaneous electrical
nerve stimulation (TENS) and placebo. There was statistically significant
pain relief by TENS and half of the patients chose to continue using TENS
for pain control after the test month. However, at one year's follow-up,
only two patients had sufficient benefit to continue using the device.

INTRODUCTION

Transcutaneous electrical nerve stimulation (TENS) has been used for

15 years for the relief of pain. For the last 10 years, modern solid-state
TENS devices have been available from numerous manufacturers and many
reports of their efficacy in pain treatment have appeared [1,2,5,11]. Most
reports have been uncontrolled and have had the additional disadvantage
that the subjects investigated have had their pains at a variety of sites and
often of undefined etiology.
Controlled studies have shown the effectiveness of TENS in controlling
acute postoperative pain [4,10,14], and one controlled study in rheumatoid
arthritis patients demonstrated a brief increased ability to resist forceable
wrist flexion after application of a TENS unit to an inflamed wrist [6].
In clinical practice, however, TENS is prescribed for weeks or months in
hopes of controlling chronic pain, and no controlled study demonstrating
the effectiveness of TENS in long-term pain has appeared.

* To whom correspondence and reprint requests should be addressed.

0304-3959/81/0000--0000/$02.50 © 1981 Elsevier/North-Holland Biomedical Press

234

Ordinarily, long-term TENS is used in one of two ways. Either the

patient returns to the hospital several times a week for TENS administered
by a therapist, or a portable TENS unit is made available to the patient
for home use after appropriate instruction in the unit's operation. Home
therapy is to be preferred in most cases. We have identified a group of
patients with knee pain due to osteoarthritis and have treated them with
either an active TENS unit or a placebo unit. The therapy is administered
by the patient at home in exactly the same manner as that used in general
clir~ical practice with the patient returning to the hospital only for evalua-
tion. These patients form the basis for this report.

METHODS

Twelve patients were identified with symptomatic osteoarthritis of the

knee who, in terms of pain and disability, were candidates for total knee
replacement. Two patients did not complete the study and were excluded
from the evaluation. The 10 who remained suffered severe pain from their
arthritis. Eight used a cane, one required crutches, and three had pain at
night. Nine patients were unable to walk even one block and two were
housebound. All patients had more pain on weight-bearing than at rest,
and 7 had pain only when weight-bearing. All patients had crepitation
and limited motion in the affected knee. One knee was unstable. All
patierits had joint space narrowing and osteophyte formation seen on
X-ray. No patient had evidence of osteoarthritis secondary to rheuma-
toid arthritis, trauma, or infection. The mean age of the 10 patients
was 71.5 years. Nine were female. Six patients had bilateral knee arthritis
and in these patients, the more symptomatic knee was chosen for study.
The, active TENS units were standard dual output Gatron stimulators.
Placebo units were constructed by the Gatron Corporation to look iden-
tical to the active units but had broken electrode wires which delivered
no current to the skin. The placebo units contained an audio device
which produced a sound that could be modulated in frequency and intensity
by the standard dials on the stimulator. Patients were told they were evalu-
ating two models of instruments, one which relieved pain by electrical
stimulation to the skin and the other which relieved pain through sound
delivery rather than an electrical current. The project was approved by the
Brigham and Women's Hospital Human Subjects Committee.
All patients were interviewed by one of the investigators (P.T.) prior to
beginning the study and informed consent was obtained. Either the active
or placebo unit was provided in a random manner. Another investigator
(L.F., who at that time had had about 2 years' experience in instructing
patients on the use of TENS) provided patients with detailed instructions
in the use of the device. For the active unit, four electrodes were placed
on the skin on the anterior, posterior, medial and lateral sides of the painful
knee. The patient was instructed to adjust the stimulator to produce a
"comfc,rtable, firm, tingling" sensation. The voltage amplitude was first
 235

turned up to make a firm, but not uncomfortable sensation. The pulse

width was increased to produce more current if the amplitude control
alone did not produce this intensity of stimulation. Next the rate was
adjusted to make the most "pleasant" feeling. Patients were instructed to
treat themselves for periods of 30.min. If the pain did not subside, they
were told to extend the treatment another 30 min. After the pain was
successfully treated, they were told to wait until the pain returned before
giving themselves a further 30 min treatment. Some patients gave themselves
periodic 30 min or 60 min treatments, while others used the unit virtually
continuously. For the placebo, electrodes were placed only on the medial
and lateral aspects of the painful knee. The voltage amplitude was turned
up to an arbitrary setting of 7 which produced a sound considered "loud"
by most listeners. The pulse width was left on the minimum setting. Patients
then adjusted the rate to produce a sound which they found most
"pleasant". As with the active units, patients were told to give themselves
30 min treatment sessions as needed. Patients tended to use the units for
longer period~ than with the active units; some did not continue to use the
unit for the entire 2 week period. L.F. did not let the patient leave the train-
ing session until she was convinced that the patient was competent in the use
of the device. She remained available by telephone to the patients for ques-
tions during the 2 week trial period.
After 2 weeks of using the first unit at home, the patient returned for
interview, and the second unit was then substituted. Following another
2 week trial, the patient was again interviewed and offered the opportunity
of using either unit for an additional month if one or the other unit had
been beneficial for their pain. All interviews were performed by the same
investigator (P.T.) without knowing whether the active or placebo unit was
being evaluated. At each interview, four parameters were recorded:
(1) Subjective. The patients were simply asked whether the TENS treat-
ment had improved their pain or not.
(2) Pain Score. Each patient was asked to choose a word that described
their present level of pain from among five words arranged in order of
increasing severity: mild - moderate- severe - very severe - unbearable.
(3) Ambulation. Patients were asked how far they could walk without
being stopped by pain.
(4) Medication. The amount of pain medicine currently being taken
by the patient was recorded.
For each patient, for each of the above parameters of pain, a score was
then obtained by comparing the responses given by the patient on subse-
quent interviews to those obtained on the initial interview prior to treat-
ment. Scoring was performed according to the following scale:

Subjective: 0 No change in pain

+1 Some pain relief
+2 Marked pain relief
+3 Complete pain relief
--1 Pain worse
236

Pain Score: 0 No change

+I Pain improved by one degree (word) in scale
+2 Pain improved by two degrees
--I Pain worse by one degree
--2 Pain worse by two degrees
Ambulation: 0 No change
+I Walking greaterdistance
+2 Walking unlimited
--I Walking lessdistance
Medication: 0 No change
+1 Taking less medication for pain
+2 Taking no medication
--I Taking more medication
Once the score for each of the four parameters had been calculated on
each patient, the code was broken and scores for the active and placebo units
were compared for all four parameters. The differences between scores for
active and placebo units were analyzed for significance by use of the one-
sided signed rank test of Wilcoxon.

RESULTS

Ten patients completed the study protocol. Their scores are listed in Table
I. Both placebo and active units generally reduced pain as indicated by
mostly positive scores in Table I. Significant differences, however, in pain
relief were noted between the active TENS units and the placebos when
evaluated by the "subjective" ( P = 0 . 0 3 ) and the "medication" (P=
0.06) criteria. The differences obtained by "verbal score" and "ambulation"
were not statistically significant.
In general, the patients who experienced pain relief with the TENS device
found that the best results occurred while the unit was operating. Some
patients, however, claimed that the pain relief lasted up to several hours
after the stimulator had been turned off. Several patients used the units
while ambulating with good relief of pain.
At the conclusion of the initial study period, 5 of the 10 subjects chose
the active unit for further use. Three of these 5 returned the units within
one month, finding them of no further benefit. Two patients have continued
to use the TENS units for 10--12 additional months. One patient
experiences limited pain relief but the other has complete pain relief lasting
24 h with only two 30 rain applications of the stimulator each day. This
second patient has recurrence of pain if one of the two daily treatments
is omitted. One of the 10 patients studied chose the placebo unit for further
use, but returned it after one additional month because of no further
benefit.
TABLE I
SCORES OBTAINED WHEN RESPONSES OF SUBJECTS WERE EVALUATED FOR BOTH ACTIVE AND PLACEBO TENS UNITS
The differences were significantbetween active and placebo units for the "subjective" (P = 0.03) and "medication" (P = 0.06) criteriabut
not for "pain score" or "ambulation".

Patient Subjective Pain score Ambulation Medications

Active Place bo Active Placebo Active Placebo Active Placebo

M.K. 1 0 --1 --1 0 0 0 0

D.E. 1 2 3 4 1 2 2 2
H.T. 0 --1 0 1 0 0 0 0
A.W. 1 0 3 0 1 0 1 0
J.C. 1 0 0 --2 0 0 1 0
C.S. 1 1 1 1 1 1 0 0
L.P. 2 1 2 1 0 0 1 0
M.D. 1 1 --2 4 0 0 0 0
M.A.D. 1 0 1 0 0 0 0 0
E.R. 0 --I 1 --i --1 0 0 --1

b~
O~
238

DISCUSSION

We have shown in this report that there is a statistical difference in pain

relief afforded by a TENS unit when compared to an inactive control device.
Thi:~ difference was noted in a 1 month double-blind cross-over clinical
trial with 2 weeks devoted to both the active and the placebo unit. Follow-
ing this trial, half of the patients studied chose to continue using the active
unit, but only two of them found the unit to be effective for pain relief
in the long term. One patient chose the placebo unit for further use.
Previous studies of TENS have usually shown a benefit in pain relief
but have been notable for lack of controls. In addition, the controlled
studies have generally used patients whose pain arose from a variety of sites
with the primary pathological process often undefined. For instance, in a
report by Thorsteinsson et al. [12], 93 patients were studied whose pain
was localized r.o at least 14 different sites (back, neck, pelvis, neuropathy,
etc.). In our study, all patients had pain due to a single diagnosis, radio-
graphically confirmed osteoarthritis of the knee, and the source of the pain
could thus be accurately established.
A difficulty in the evaluation of the effect of TENS is the placebo effect.
Thorsteinsson et al. [ 13] found a placebo device to relieve pain in 32% of
trials and our study as well demonstrated a pain-relieving effect of the
placebo units. A criticism directed at previously employed placebo devices
is that patients can identify placebo units because of the lack of skin stimula-
tion. Most previous controlled studies with TENS have used totally inactive
units (usually standard stimulators merely switched off) as the placebo unit
and patients can easily determine when the placebo is being applied. We have
attempted to alleviate this problem by designing our placebo units to be
"active" with an audible signal and by informing study subjects not to
expect skin stimulation if the unit produces a noise.
Our placebo devices produced an audible signal. Many patients
experienced some pain relief with these units, but it is unlikely that there
was any significant direct analgesic effect of sound. One study on the use of
sound for analgesia showed that the sound had to be quite loud and the
subjects had to concentrate on the noise for there to be any demonstrable
effect [ 8].
Another potential source of error in our study is the large preponderance
of female patients seen. The sex ratios for osteoarthritis of the knee have
not been established, although it is unlikely it is as high as the 9 : 1 ratio
in our study population. Our arthritis clinic population is about 3 : 1 female
which may partially explain the increased incidence of women studied since
our patients were obtained from this source. It should be noted, in addition,
that our patients generally complained of severe, disabling knee pain and our
results may not be applicable to lesser degrees of pain.
The study was conducted in a manner simulating clinical practice. The
subjects were "allowed to use the stimulator at home without a technician's
supervision and the results obtained should be directly applicable to the
 239

usual clinical problem of long-term pain. After a 2 week trial period, patients
were allowed to continue using the device as long as it was of value to them.
However, in spite of the statistically significant differences seen with the
active TENS unit after the 1 month study period and 5 of the 10 patients
choosing to continue using TENS for pain relief, only two patients were
continuing to use the stimulator after about 1 year. Only one of these
two had significant pain relief. The good short-term but poor long-term
results demonstrated in our study confirm the general impressions of those
who use TENS clinically [ 5,9]. In our situation it is also possible that the
less good long-term results are due to the fact that the clinical problem it-
self is worsening.
The mechanism of action of TENS in producing analgesia is unknown.
One leading possibility concerns the gate-control theory of pain and has
been recently reviewed by Wolf [15]. More recently, with the discovery
of the enkephalins and endorphins, endogenous morphine-like neuro-
peptides, the possibility that enkephalin production may explain the anal-
gesic effect of TENS has been suggested [ 13 ]. There is, however, no experi-
mental evidence at this time to support this enkephalin hypothesis. Cere-
brospinal fluid methionine-enkephalin concentrations have been shown to
rise in response to electro-acupuncture [3], and the opiate antagonist nalo-
xone has been shown to reduce the effects of acupuncture analgesia [ 7]. The
mechanisms of analgesia production by TENS and acupuncture may be
similar and may be due to stimulation of central nervous system enkephalin
formation.
A previous report by Mannheimer in a controlled study of rheumatoid
arthritis patients [6] demonstrated acute relief of wrist pain by TENS.
No other study besides our own has specifically evaluated TENS for arthritis.
The results of the present study suggest that TENS may be an alternative
method of short-term pain relief in patients with knee arthritis who for
some reason are not thought suitable for total knee replacement surgery.

ACKNOWLEDGEMENTS

We gratefully acknowledge the support of the Gatron Corporation who

supplied all the TENS units used in this study. We also wish to thank
Carolyn Collier for typing the manuscript.

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240

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