Research Report

C.G.T. Vance, PT, MS, Graduate

Program in Physical Therapy and
Rehabilitation Science, The University of Iowa, Iowa City, Iowa.
B.A. Rakel, RN, PhD, College of
Nursing, The University of Iowa.
N.P. Blodgett, RN, MS, College of
Nursing, The University of Iowa.
J.M. DeSantana, PT, PhD, Department of Physical Therapy, Federal
University of Sergipe, Aracaju,
Brazil.
A. Amendola, MD, Department of
Orthopedics and Rehabilitation,
The University of Iowa.
M.B. Zimmerman, PhD, Department of Biostatistics, College of
Public Health, The University of
Iowa.
D.M. Walsh, PT, PhD, Health and
Rehabilitation Science Research
Institute, University of Ulster,
Newtownabbey, United Kingdom.
K.A. Sluka, PT, PhD, Graduate Program in Physical Therapy and
Rehabilitation Science, The University of Iowa, 1-252 Medical
Education Building, Iowa City,
IA 52242 (USA). Address all correspondence to Dr Sluka at:
kathleen-sluka@uiowa.edu.
[Vance CGT, Rakel BA, Blodgett
NP, et al. Effects of transcutaneous
electrical nerve stimulation on
pain, pain sensitivity, and function
in people with knee osteoarthritis:
a randomized controlled trial. Phys
Ther. 2012;92:898 910.]
2012 American Physical Therapy
Association
Published Ahead of Print:
March 30, 2012
Accepted: March 22, 2012
Submitted: June 1, 2011

Effects of Transcutaneous Electrical

Nerve Stimulation on Pain, Pain
Sensitivity, and Function in People
With Knee Osteoarthritis:
A Randomized Controlled Trial
Carol Grace T. Vance, Barbara A. Rakel, Nicole P. Blodgett,
Josimari Melo DeSantana, Annunziato Amendola, Miriam Bridget Zimmerman,
Deirdre M. Walsh, Kathleen A. Sluka

Background. Transcutaneous electrical nerve stimulation (TENS) is commonly

used for the management of pain; however, its effects on several pain and function
measures are unclear.
Objective. The purpose of this study was to determine the effects of highfrequency TENS (HF-TENS) and low-frequency TENS (LF-TENS) on several outcome
measures (pain at rest, movement-evoked pain, and pain sensitivity) in people with
knee osteoarthritis.

Design. The study was a double-blind, randomized clinical trial.

Setting. The setting was a tertiary care center.
Participants. Seventy-five participants with knee osteoarthritis (29 men and 46
women; 3194 years of age) were assessed.
Intervention. Participants were randomly assigned to receive HF-TENS (100 Hz)
(n25), LF-TENS (4 Hz) (n25), or placebo TENS (n25) (pulse duration100
microseconds; intensity10% below motor threshold).
Measurements. The following measures were assessed before and after a single
TENS treatment: cutaneous mechanical pain threshold, pressure pain threshold
(PPT), heat pain threshold, heat temporal summation, Timed Up & Go Test (TUG),
and pain intensity at rest and during the TUG. A linear mixed-model analysis of
variance was used to compare differences before and after TENS and among groups
(HF-TENS, LF-TENS, and placebo TENS).
Results. Compared with placebo TENS, HF-TENS and LF-TENS increased PPT at the
knee; HF-TENS also increased PPT over the tibialis anterior muscle. There was no
effect on the cutaneous mechanical pain threshold, heat pain threshold, or heat
temporal summation. Pain at rest and during the TUG was significantly reduced by
HF-TENS, LF-TENS, and placebo TENS.

Limitations. This study tested only a single TENS treatment.

Conclusions. Both HF-TENS and LF-TENS increased PPT in people with knee
osteoarthritis; placebo TENS had no significant effect on PPT. Cutaneous pain measures were unaffected by TENS. Subjective pain ratings at rest and during movement
were similarly reduced by active TENS and placebo TENS, suggesting a strong
placebo component of the effect of TENS.

Post a Rapid Response to

this article at:
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Transcutaneous Electrical Nerve Stimulation and Osteoarthritis

ranscutaneous electrical nerve

stimulation (TENS) is an inexpensive, noninvasive intervention used to manage a wide variety of
painful conditions. Previous studies
showed that TENS increases pressure and heat pain thresholds in people who are healthy1 6 and reduces
mechanical and heat hyperalgesia in
arthritic animals.7,8 However, a
recent systematic review showed
that TENS was not effective for knee
osteoarthritis (OA) pain,9 in direct
contrast to an earlier systematic
review that concluded that TENS
was effective for knee OA pain10 and
a meta-analysis that showed a significant reduction in knee OA pain with
TENS.11 Several limitations in the
included trials may explain the lack
of effect of TENS; these include small
sample size, poor methodological
quality, and inadequate randomization and blinding.
A key factor that may explain the
lack of effect of TENS is that pain at
rest was the main outcome routinely
examined in earlier studies.9 However, TENS has a greater effect on
movement-evoked pain and subsequently results in improved function.12 Evoked stimuli are used to

measure painlike behaviors in animal

studies and commonly used to examine responses at the site of injury (ie,
primary hyperalgesia) and outside
the site of injury (ie, secondary
hyperalgesia). Primary hyperalgesia
and secondary hyperalgesia are surrogate measures for sensitization of
the peripheral nervous system (at
site of injury) and central nervous
system (outside site of injury),
respectively. It is possible that the
effectiveness of TENS varies by
outcome.
Dosing also is critical to the effectiveness of TENS.1215 Animal studies
show that both high-frequency TENS
(HF-TENS, 50 Hz) and lowfrequency TENS (LF-TENS, 10 Hz),
delivered at an intensity of 90% of
the motor threshold (strong sensory
intensity), reduced pain sensitivity in
arthritic animals.16 20 Several studies
of HF-TENS in people who are
healthy show that higher intensities,
generally described as strong but
comfortable, resulted in greater pain
reduction.2,6,13,14,21,22 Similarly, studies of postoperative pain show that
adequate intensities are necessary to
produce analgesia and that low
intensities are ineffective.12,15 It is

The Bottom Line

unclear whether the frequencies and

intensities used in animal studies will
have similar effects in people.
The purposes of this study were:
(1) to determine the efficacy of
HF-TENS and LF-TENS for knee OA
pain and (2) to determine which
outcome measures (pain at rest,
movement-evoked pain, pain sensitivity, and function) are most likely
to be affected by HF-TENS and
LF-TENS in people with pain to
inform the design of future studies.
We compared the effect of TENS,
applied with parameters used in our
earlier animal studies,13,14,16,2228
with the effect of a new placebo
TENS on pain at rest, movementevoked pain, pain sensitivity measures, and function in people with
OA. We hypothesized that both
HF-TENS and LF-TENS would reduce
pain during movement but not pain
at rest, decrease pain sensitivity, and
increase function.

Method
Design Overview
This study was a double-blind, randomized clinical trial that included
75 people who had knee OA and
were randomly allocated to 1 of 3
groups (HF-TENS, LF-TENS, and placebo TENS). Outcome measurements were obtained before and during a single TENS treatment.

What do we already know about this topic?

A substantial body of literature shows that TENS produces analgesia in
both animal and human subjects with a variety of pain conditions by using
endogenous opioid pathways. Systematic reviews of TENS for knee OA
offer conflicting positions. Although prior studies routinely examine resting pain as their main outcome, TENS may work more effectively for pain
at rest, movement-evoked pain, and pain sensitivity.

What new information does this study offer?

This study evaluated the effect of TENS, applied with parameters used in
prior animal studies, with a new placebo TENS on a variety of outcomes
including resting and movement pain, pain sensitivity, and function in
subjects with OA. There was a significant reduction in evoked pain
measures but not in resting pain with TENS.

July 2012

Available With
This Article at
ptjournal.apta.org
Discussion Podcast with authors
Kathleen Sluka and Myrto
Dounavi and Meryl Gersh,
Co-chair of the Electrotherapy/
Therapeutic Technologies Group,
APTA Section on Clinical
Electrophysiology and Wound
Care. Moderated by Steven
George.

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Transcutaneous Electrical Nerve Stimulation and Osteoarthritis

Figure 1.
CONSORT diagram. Most people were excluded from the initial screening because of earlier transcutaneous electrical nerve
stimulation (TENS) use or minimal pain. However, all participants allocated to a group completed the study. CNScentral nervous
system, CVAcerebrovascular accident, OAosteoarthritis.

Setting and Participants

Study participants were recruited
through flyers and active screening
by experimenters in the orthopedic
and sports medicine department of
a large midwestern tertiary care
center. Inclusion criteria were as
follows: diagnosis of medialcompartment knee OA (radiographically and symptomatically diagnosed
by an orthopedic surgeon), 18 to
95 years of age, able to ambulate
to mailbox and back, stable medication schedule for 3 weeks before
testing, and pain rating of greater
than 3 of 10 during weight bearing
(on a verbal rating scale). Lateralcompartment
knee
OA
was
excluded to standardize the test sites
for pain sensitivity measures. A pain
rating of less than 3 of 10 was
needed to derive a clinically meaningful change attributable to the
intervention.
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Physical Therapy

Initial screening was performed by

the recruiter, or telephone screening
was conducted by the project coordinator to determine inclusion.
Exclusion criteria were as follows:
uncontrolled diabetes mellitus or
hypertension, dementia or cognitive
impairment, neurological disorder,
permanent lower-extremity sensory
loss, earlier TENS use, knee surgery
in last 6 months, or knee injection in
last 4 weeks. To avoid interactions
with medications, participants were
given instructions not to take any
analgesic medication 4 hours before
the testing session. At the first visit,
we obtained a complete list of medications currently being taken and
assessed bilateral recognition of
sharp versus dull pressure at the
L3S2 dermatomes and proprioception of the great toe to rule out loss
of sensation (an exclusion criterion).
All testing was conducted in 1 of 2

dedicated research spaces at The

University of Iowa.
Figure 1 shows the CONSORT diagram for this randomized controlled trial. As illustrated, 311 people were assessed for eligibility,
and 87 declined to participate. We
were unable to make contact with
31 people, and 116 were excluded.
Seventy-five of the remaining 77
people were allocated to treatment groups and completed the testing. Two people were excluded in
the secondary screening process
because of reduced sensation and lateral joint pain.
Randomization and Intervention
An allocation concealment protocol
with
sequentially
numbered,
opaque, sealed envelopes and permuted blocks of 3 and 6 was used to
randomize participants to groups.29

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Transcutaneous Electrical Nerve Stimulation and Osteoarthritis

Allocation envelopes were kept in a
location separate from the testing
location and were not available to
the data collection examiner. The
foil-lined envelopes were signed,
dated, and opened by the allocation
examiner immediately before TENS
application and after the data collection examiner left the room.
A commercially available TENS unit
(Rehabilicare Maxima, DJO Inc,
Vista, California) was used to deliver
TENS. The unit uses an asymmetrical, biphasic waveform, the pulse
duration was set at 100 microseconds, and the intensity was 10%
below the motor threshold. We
chose to modulate frequency and
keep all other parameters the same
to test whether there is a frequencydependent effect on outcomes. The
same parameters were previously
used in preclinical animal and
human studies of TENS in our laboratory.13,14,16,2328 The placebo TENS
unit (DJO Inc) was identical in
appearance to the TENS unit, and
placebo TENS was applied in the
same manner as active TENS (100
Hz, 100-microsecond pulse duration,
and intensity 10% below motor
threshold). The new transient placebo TENS unit delivered a current
for the first 30 seconds and then
ramped down to zero over 15 seconds. The transient placebo is valid
and has no effect on pain measures
in healthy controls.13 Neither the
TENS allocation examiner nor the
data collection examiner could differentiate between active TENS and
placebo TENS and, importantly, all
participants received the same set of
instructions. Blinding was assessed
at the end of TENS treatment and
before participants left the clinic.
Participants were asked if they
thought they received active TENS
or placebo TENS.
Transcutaneous electrical nerve
stimulation was applied with 4 selfadhesive electrodes (5 5 cm
July 2012

[2 2 in]; DJO Inc) to bracket the

knee with OA and to apply paresthesia encompassing the painful knee.
Two electrodes were placed above
the knee, and 2 were placed below.
The current was delivered across the
joint through 2 channels. One channel was connected to an electrode
above the knee medially and below
the knee laterally; the second channel was connected to an electrode
above the knee laterally and below
the knee medially. The specific electrode sites were determined by the
allocation examiner using points of
least impedance.30 To locate the
points, the participant and the examiner each held a gelled electrode in
his or her hand. The examiner completed the circuit by placing a waterdipped finger on the participants
skin and increasing the intensity to
the experimenters sensory threshold. The examiner then glided her
finger over the area to locate the
points of least impedance (ie, points
at which increased sensation
occurred for the examiner). The
points were always located within
the frontal plane and within 25 to 75
mm of the midpatella. The points
were cleaned with water, and the
electrodes were applied.
The TENS units were turned on for
20 minutes before testing to reach
the peak effect and were turned off
when testing was completed, for a
total application time of 40 to 50
minutes. The greatest effects of
TENS occur when the unit is on. All
of our measurements were obtained
in the same order so that quantitative
sensory testing was done immediately after 20 minutes and function
testing (Timed Up & Go Test
[TUG]) was performed last. Therefore, we were comparing the effectiveness of the same length of TENS
treatment across participants.

Outcome Measures and

Follow-up
Subjective pain intensity. Participants were asked to rate their pain
on a horizontal 100-mm visual analog
scale (VAS). The anchors were no
pain and worst imaginable pain.
The VAS is valid and reliable compared with other pain rating scales
(r.71.78, intraclass correlation
coefficient [ICC].71.99).31,32 Pain
was assessed at rest, during the TUG,
and during heat temporal summation
(HTS).
Pain sensitivity. Pain sensitivity
was measured with the quantitative
sensory tests outlined below. Three
sites were marked 1 cm apart at the
medial joint line bilaterally. Another
3 sites were marked 2.5 cm apart on
the tibialis anterior muscle bilaterally, with the top site being marked
7.5 cm below the inferior border of
the patella. All pain sensitivity measurements were obtained at all 6
sites, except for the heat pain threshold (HPT) and HTS (see below),
which were obtained over the middle point of the knee and tibialis
anterior muscle because of the larger
size of the thermode stimulator
probe. All sites were assessed
bilaterally.
Cutaneous
mechanical
pain
threshold (CMPT). The CMPT
was assessed with a set of 20 von
Frey filaments (North Coast Medical,
Gilroy, California) applied to the test
sites in ascending order (0.008 300
g). The tip of the filament was
applied perpendicular to the site and
pressed until bending occurred. One
trial per filament was done. The
CMPT has excellent test-retest reliability (r.97).32
Pressure pain threshold (PPT).
The PPT was assessed with a handheld pressure algometer (Somedic
AB, Farsta, Sweden) applied at 40
kPa/s (1-cm2 circular tip). Participants were instructed to press the

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Transcutaneous Electrical Nerve Stimulation and Osteoarthritis

Figure 2.
Time line for the 3-hour testing session. CMPTcutaneous mechanical pain threshold, HFhigh frequency, HPTheat pain
threshold, HTSheat temporal summation, LFlow frequency, PPTpressure pain threshold, TENStranscutaneous electrical nerve
stimulation, TUGTimed Up & Go Test, VASvisual analog scale.

handheld response switch when the

sensation first became painful. Participants were familiarized with the
procedure by performing a practice
test on the forearm. The PPT has
excellent
test-retest
reliability
(r.70 .94) and is a valid measure
for deep-tissue hyperalgesia, as indicated by earlier studies showing
decreases in chronic pain compared
with the responses in healthy
controls.33
HPT. The HPT was assessed by use
of a TSA II NeuroSensory Analyzer
(Medoc Ltd, Ramat Yishai, Israel)
with a 5-cm2 probe. The probe was
placed at the middle of the 3 marks
at each site. The temperature was
initially set at 37C and increased
1C/s to a maximum of 52C. Participants indicated when they first felt
pain (1/10) by pushing a button that
terminated the stimulus.

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HTS. The HTS was measured with

a TSA II NeuroSensory Analyzer. A
tonic heat stimulus of 45.5C was
applied for 20 seconds. After the first
5 seconds of the heat stimulus application, participants rated pain every
5 seconds for 15 seconds. A difference between the pain rating (first
rating) at 5 seconds and the pain
rating at 15 seconds was used for
analysis. Thermal measures have
good test-retest reliability (ICC.77)
in people with knee OA.32

with the chair. We previously used

the TUG in people with OA and
found a reduction in TUG walking
time, demonstrating the sensitivity
of the TUG to a single joint mobilization treatment.35 The TUG has
good reliability (ICC.92.99) in
elderly populations34,36,37 and has
good construct validity and significant correlations with gait speed
(r.61.75), the Berg Balance Scale
(r.81),
and
step
length
(r.77).36,37

TUG. The TUG is a standardized

test in which people arise from a
chair with no arm rest, ambulate
approximately 3 m (9.8 ft) as quickly
as possible, turn, ambulate back,
turn, and return to sitting in the
chair.34 Participants were timed in a
standardized fashion from the
moment the upper back left the
chair until return to the full sitting
position with the back in contact

Test protocol. A time line of the

test protocol is shown in Figure 2.
All testing was performed with the
same equipment and by the same
examiner. At the testing session,
informed consent was obtained and
sensory screening was done. If the
sensory examination results were
normal, testing began. First, participants completed a demographic
questionnaire, and height and

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Transcutaneous Electrical Nerve Stimulation and Osteoarthritis

Table 1.
Demographic Characteristics of Study Participants and Outcome Measures Before Transcutaneous Electrical Nerve Stimulation
(TENS)a
Variable

High-Frequency TENS

Low-Frequency TENS

Placebo TENS

Age, XSEM

5711.8

5514.4

5710.9

.756

Men, n (%)

11 (44)

9 (36)

9 (36)

.492

Demographic characteristic

Women, n (%)
Body mass index, kg/m2, XSEM

14 (56)

16 (64)

16 (64)

.492

33.67.7

36.26.0

39.27.0b

.027

Pain on screening (010), XSEM

5.61.9

5.51.7

5.62.3

.95

Knee pain duration (mo), XSEM

108.8113

121.6141.2

83.586.4

.743

Analgesic medication use, no. (%)

18 (72)

20 (80)

18 (72)

.757

Nonopioid

17 (68)

20 (80)

17 (68)

.556

Opioid

4 (16)

4 (16)

3 (12)

.900

17.75.0 (7.428.0)

29.55.3 (18.640.5)

21.25.1 (10.831.7)

.251

Baseline ipsilateral outcome measures,

XSEM (95% CI)
Pain at rest (100-mm scale)
Pain during TUG (100-mm scale)

24.24.4 (15.233.3)

28.34.6 (18.837.9)

27.54.4 (18.436.5)

.792

TUG walking time (s)

12.10.81 (10.413.8)

14.71.66 (11.318.2)

13.41.0 (11.215.5)

.315

CMPT (g)

1,394111 (1,1651,623)

1,105131 (8351,376)

1,023150 (7131,333)

.119

PPT of knee (kPa)

315.727.0 (259.9371.4)

247.820.2 (206.1289.6)

259.520.6 (217.0302.0)

.087

PPT of tibialis anterior muscle (kPa)

349.537.9 (271.4427.7)

319.030.9 (255.2382.7)

319.430.1 (257.2381.5)

.757

HPT of knee (C)

45.50.45 (44.546.4)

43.20.71b (41.744.6)

44.5.52 (43.545.6)

.020

HPT of tibialis anterior muscle (C)

46.30.52 (45.247.4)

45.40.67 (44.046.8)

45.5.57 (45.345.7)

.66

24.74.7 (1434.4)

37.35.1 (26.848)

27.64.4 (18.636.7)

.15

HTS (5 s) (100-mm scale)

HTS (10 s) (100-mm scale)

28.85.5 (17.540.1)

35.65.3 (24.746.5)

31.14.7 (21.640.8)

.64

HTS (15 s) (100-mm scale)

30.66.0 (18.342.9)

37.45.6 (25.949.0)

28.34.3 (19.337.2)

.46

a
CIconfidence interval, TUGTimed Up & Go Test, CMPTcutaneous mechanical pain threshold, PPTpressure pain threshold, HPTheat pain
threshold, HTSheat temporal summation.
b
Significantly different from values for other groups.

weight were recorded. Pain at rest

was measured before pain sensitivity. The order of the following measurements remained consistent for
all participants: CMPT, PPT, HPT,
and HTS. The testing order for each
of the 4 areas and 3 test sites was
randomized to prevent an ordering
effect of testing. Participants then
completed the TUG and rated their
maximum pain during this test.
Once testing was completed, the
data collection examiner left the
room and the allocation examiner
allocated TENS. The allocation examiner stayed with the participant for
20 minutes, at which time the data
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collection examiner reentered and

repeated the testing as described
above. The same blinded examiner
obtained all outcome measurements
before and after TENS. Once the second testing session was completed,
the TENS allocation examiner
returned to remove the TENS unit
and assess participant blinding.
Data Analysis
Sample size calculations were made
with preliminary PPT data to compare HF-TENS and LF-TENS against
placebo TENS. Pain thresholds are
commonly used in studies of animals
and people who are healthy.1,7,13,16,25
The study sample size of 25 partici-

pants per group was determined on

the basis of an expected PPT difference of 100 kPa, a standard deviation
of 110, a significance level of .05,
and a power of .80. For the other
outcome measures, the detectable
differences were at least 10 mm
(out of 100 mm) on the VAS (SD
0.9) and 1.4 seconds on the TUG
(SD1.5). Therefore, the sample size
was powered to detect clinically significant differences in all variables,
given that pain ratings and impairments are minimal in early OA.38
Mean and standard error of the mean
were calculated for all variables
before and after TENS and for the

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Transcutaneous Electrical Nerve Stimulation and Osteoarthritis

Table 2.
Primary and Secondary Measures Expressed as Difference Scoresa
Difference Score, XSEM (95% Confidence Interval)
Variable

High-Frequency TENS

Low-Frequency TENS

Placebo TENS

PPT of knee (kPa)

65.8117.05b (30.6 to 101.0)

51.5020.65b (8.9 to 94.1)

22.613.66 (5.6 to 50.8)

PPT of tibialis anterior muscle (kPa)

82.1418.90b (43.1 to 121.1)

44.2015.50 (12.2 to 76.2)

20.6716.27 (12.9 to 54.2)

0.40.29 (0.13 to 1.06)

0.720.46 (0.23 to 1.66)

0.520.36 (0.22 to 1.23)

10.324.00 (2.05 to 18.59)

16.145.23 (5.34 to 26.94)

16.844.81 (6.09 to 26.78)

9.442.56 (4.15 to 14.73)

8.703.93 (0.58 to 16.82)

14.183.55 (6.86 to 21.50)

TUG walking time (s)

Pain at rest (0100 mm)
Pain during TUG (0100 mm)
CMPT of knee (g)

15395 (18 to 324)

25983 (87 to 431)

1983 (152 to 191)

CMPT of tibialis anterior muscle (g)

271101 (68 to 479)

14466 (7.8 to 280)

2487 (204 to 156)

HPT of knee (C)

0.060.36 (0.68 to 0.8)

1.30.55 (0.18 to 2.4)

0.20.28 (0.78 to 0.38)

HPT of tibialis anterior muscle (C)

0.50.34 (0.2 to 1.2)

HTS of knee (100-mm scale)

1.31.6 (4.5 to 1.9)

HTS of tibialis anterior muscle

(100-mm scale)

1.11.9 (4.8 to 2.6)

0.090.36 (0.65 to 0.83)

0.30.36 (2.3 to 2.9)
0.81.0 (2.9 to 1.3)

0.080.46 (0.87 to 1.0)

3.92.3 (8.7 to 0.89)
0.081.2 (2.4 to 2.6)

a
TENStranscutaneous electrical nerve stimulation, PPTpressure pain threshold, TUGTimed Up & Go Test, CMPTcutaneous mechanical pain
threshold, HPTheat pain threshold, HTSheat temporal summation.
b
Significantly different from placebo value.

difference score before and after

TENS within individual groups. In
addition, 95% confidence intervals
were calculated for primary outcome measures. A linear mixedmodel analysis for repeated measures was used to compare mean
changes among treatment groups
(HF-TENS, LF-TENS, placebo TENS)
in the outcome measures for the
site (knee, tibialis anterior muscle),
side (affected, contralateral), and
time (before, after) (within-subjects
effects). The model included baseline values and body mass indexes
as covariates because body mass
indexes differed between groups
(Tab. 1). For specific comparisons
of interest, a test of mean contrasts
based on the fitted method was
performed. To account for the multiple tests performed in relation to
a specific hypothesis, P values
were adjusted with the Bonferroni
method. The Kruskal-Wallis test was
used to detect differences in nonparametric data.
Role of the Funding Source
This study was supported by the
National Institutes of Health (R03904

Physical Therapy

NR010405), a Marsha and Ralph

Congdon Faculty Development Fellowship in Acute Care for the Chronically Ill, and The University of Iowa
Carver College of Medicine.

Results
Table 1 shows the demographic
information for all treatment groups
as well as the baseline values for
each measure. There were no significant differences between groups in
demographic characteristics, with
the exception of body mass indexes
(P.027). Therefore, body mass
indexes were controlled for in the
analyses. All baseline measures were
similar between groups, with the
exception of HPT (P.02). Baseline
measures were also controlled for in
the analyses. Eleven participants
(15%) were taking opioid medications for pain control, and 54 (72%)
were taking nonopioid medications.
There were no significant differences between groups in the numbers of participants taking analgesic
medications (Tab. 1).

TENS Amplitude and Blinding

The pulse amplitudes required to
achieve the desired TENS treatment
intensities were similar between
groups; the mean amplitudes were
27.4 mA (SD1.70) for HF-TENS,
24.1 mA (SD1.8) for LF-TENS, and
24.5 mA (SD1.6) for placebo TENS.
Of the participants receiving placebo
TENS, 57% correctly identified the
treatment as a placebo, whereas 43%
believed that they received the active
treatment. Participants receiving
active TENS correctly identified the
treatment as active 92% of the time.
Pain Sensitivity
High-frequency TENS increased PPT
at the affected knee (P.002) and
over the anterior tibialis muscle of
the affected leg (P.0001) compared with pre-TENS values (Tab. 2,
Fig. 3). Low-frequency TENS significantly increased PPT at the ipsilateral
knee only (P.05). Placebo TENS
did not significantly change PPT
(Fig. 3). Pairwise comparisons of the
treatment groups revealed a significant difference in the mean changes
in PPT between HF-TENS and placebo TENS (P.026); there was no

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significant
difference
between
LF-TENS and placebo TENS or
between LF-TENS and HF-TENS.
Baseline CMPT, HPT, and HTS values
for each group before TENS are
shown in Table 1. The HPT, CMPT,
and HTS values were unchanged
after all treatments, and there were
no significant differences between
groups (Tab. 2).
Pain at Rest
Pain at rest decreased significantly in
all 3 groups (P.001, P.01, and
P.0001 for HF-TENS, LF-TENS, and
placebo TENS, respectively). However, there were no significant differences between groups (Tab. 2,
Fig. 4).
Function (TUG) and Pain During
Function
Pain during the TUG decreased significantly in all 3 groups (P.001,
P.03, and P.001 for HF-TENS,
LF-TENS, and placebo TENS, respectively). However, there were no significant differences between groups
(Tab. 2, Fig. 5). The time to perform
the TUG did not change significantly
in any of the groups, and there were
no significant differences between
groups (Tab. 3).

Figure 3.
Differences between pressure pain threshold (PPT) before transcutaneous electrical
nerve stimulation (TENS) and PPT after TENS for both the knee and the tibialis anterior
muscle both ipsilaterally and contralaterally. Data are expressed as the mean and
standard error of the mean. *significantly different from baseline, significantly
different from placebo. HFhigh-frequency TENS, LFlow-frequency TENS, Pplacebo
TENS.

Discussion
The present study showed an
increase in PPT at the knee joint with
HF-TENS and LF-TENS and over the
tibialis
anterior
muscle
with
HF-TENS relative to the results
obtained with placebo TENS; placebo TENS had no significant effect
on PPT. However, subjective pain at
rest and during the TUG decreased
equally with all 3 treatments. No differences were observed for CMPT,
HPT, HTS, or function. These data
show that TENS is effective for deeptissue pain sensitivity induced by
OA. They further show that a single
treatment of TENS has minimal
effects on pain and function relative
to the effects of placebo TENS.
July 2012

Figure 4.
Difference scores for pain at rest in ipsilateral and contralateral knees during transcutaneous electrical nerve stimulation (TENS). Significant decreases were observed ipsilaterally for all 3 groups (placebo TENS [P], low-frequency TENS [LF], and highfrequency TENS [HF]). Data are expressed as the mean and standard error of the mean.
*significantly different from baseline.

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Transcutaneous Electrical Nerve Stimulation and Osteoarthritis

Figure 5.
Difference scores for movement-evoked pain during the Timed Up & Go Test (TUG)
in ipsilateral and contralateral knees during transcutaneous electrical nerve stimulation
(TENS). Significant decreases were observed ipsilaterally for all 3 groups (placebo TENS
[P], low-frequency TENS [LF], and high-frequency TENS [HF]). Data are expressed as the
mean and standard error of the mean. *significantly different from baseline.

HF-TENS and LF-TENS Reduce

Deep-Tissue Pain Sensitivity
The present study showed that
HF-TENS and LF-TENS increase PPT
at the site of injury; we interpret this
finding as a reduction in primary
hyperalgesia. Changes in primary
hyperalgesia
measures
suggest
changes in nociceptor sensitivity39
and parallel changes that we previously observed in animal studies.25
The present study also showed that
HF-TENS increases PPT over the tibialis anterior muscle, an area outside
the site of injury; we interpret this
finding as a reduction in secondary

hyperalgesia. Changes in secondary

hyperalgesia
measures
suggest
changes in central neuron excitability39 and parallel changes that we
previously observed in animal studies.19 The increases in PPT are similar
to increases in PPT during active
TENS in healthy controls1 6,13,14 and
in arthritic animal models examining
hyperalgesia immediately after TENS
with the same parameters.16,20,24
Transcutaneous electrical nerve
stimulation reduces the excitability
of nociceptive neurons in the central
nervous system in arthritic animals,40
and higher intensities produce

Table 3
Timed Up & Go Test (TUG) Walking Times Before and During Transcutaneous
Electrical Nerve Stimulation (TENS)a
TUG Walking Time, s (XSEM)
Group

Baseline

Difference

Placebo TENS

13.41.0

12.90.98

0.520.36

Low-frequency TENS

14.71.6

14.01.4

0.720.46

High-frequency TENS

12.10.8

11.60.83

0.470.29

There were no differences among TENS groups.

906

During
TENS

Physical Therapy

greater reductions in excitability.41

Therefore, changes in PPT with
TENS are likely mediated by reduced
central neuron excitability. The present study is the first to show the
effects of TENS on hyperalgesia in
people with OA; these effects may
serve as a useful measure of neuron
excitability. The PPT correlates with
movement-evoked pain (Sluka KA,
Rakel BA, et al, unpublished observations); both are evoked pain stimuli.
Furthermore, palpation tenderness is
an essential part of the physical
examination of patients; PPT measures may offer clinicians an
improved objective measure of
tenderness.
The reason for the lack of changes in
CMPT, HPT, or HTS may have been
the fact that these measures are cutaneous stimuli and are not sensitized
by knee OA. A previous study of OA
showed greater enhanced temporal
summation to pressure in people
with more pain.42 However, a recent
study showed enhanced HTS in people with OA.43 Alternatively, TENS
may have minimal effects on cutaneous heat pain but be more effective
for deep-tissue pain. In support of
this notion, we found no change in
HPT with TENS in people who were
healthy44 but significant reductions
in PPT and temporal summation to
mechanical stimulation of muscle.13
Together, these data support the
idea that TENS is more effective in
reducing deep-tissue hyperalgesia.
Effects of TENS on Pain and
Function
We previously showed that active
TENS reduced movement-evoked
postoperative pain relative to the
results obtained with placebo
TENS.12 Surprisingly, the present
study showed equivalent reductions
in pain during the TUG with both
active TENS and placebo TENS but
no changes in function. The reason
for the lack of difference between
active TENS and placebo TENS may

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be the fact that the TUG minimally
increased pain above that at rest
(10 mm/100 mm), suggesting that
the TUG did not produce enough
pain in our participants to evaluate
movement-evoked pain. In contrast
to the present study, which involved
a single visit, 2 weeks of active TENS
reduced TUG walking times in people with symptomatic knee OA relative to the results obtained with placebo TENS.45 We previously showed
decreases in TUG walking times in
people with OA after a single joint
mobilization,35 demonstrating the
capacity of a single treatment to
modify TUG walking times. It is possible that the difference between
studies with improvements in the
TUG and the present study is related
to the severity of functional limitations. For instance, in earlier OA
studies showing a positive effect on
the TUG, the times were 20 to 24
seconds,35,45,46 whereas the times in
the present study were 12 to 14 seconds, close to normal (10 seconds).34 Therefore, for less severe
symptomatic OA, the TUG may not
be an appropriate measure for examining movement-evoked pain and
function. Future studies should use a
function test that produces greater
pain, such as stair climbing.
We previously showed no significant
effect of TENS on pain at rest (VAS)
relative to the effect of placebo TENS
after abdominal surgery.47 In the
present study, both placebo TENS
and active TENS reduced ratings of
pain at rest by 10 to 18 mm out of
100 mm. These changes are minimal
and not clinically important when
people have pain ratings below 50 of
100 mm on the VAS38; pain ratings in
our participants averaged between
24 and 28 mm. Therefore, the effects
on pain at rest may depend on the
pain intensity.
Earlier work showed that high doses
of caffeine can reduce analgesia
produced by TENS.48 In the present
July 2012

study, we did not control for caffeine; therefore, caffeine may have
influenced our results. However,
our earlier studies of people who
were healthy did not control for caffeine and showed positive effects
of active TENS relative to placebo
TENS,13,14,22,49 and we showed
effects on PPT in the present study.
Opioid intake also may influence
results; people and animals who are
tolerant of opioids showed reduced
effects of LF-TENS but not
HF-TENS.23,50 However, the majority
of our participants (85%) were not
taking opioid analgesics, and the
numbers of participants taking opioid analgesics were similar between
groups. Additionally, participants did
not take analgesic medications for 4
hours before testing to eliminate the
effect of analgesia on the test results.
Intensity Is Critical for TENS
Effectiveness
Earlier studies of people with OA
included in the 2009 Cochrane
review9 supported the need for highintensity TENS. Intensities in the
included studies varied widely.9
High-frequency TENS was given at a
strong but comfortable intensity in 7
trials,45,46,5155 at sensory threshold
or below in 5 trials,56 60 at a noxious
level in 1 trial,61 and at an unreported intensity in 2 trials.62,63 Lowfrequency TENS was applied at a
motor intensity in 3 studies64 66 and
a strong sensory intensity in 1
study.45 Trials that reported effective
TENS generally used higher intensities than those that reported no
effect. In the present study, TENS
was applied at 90% of the motor
threshold, a strong sensory intensity.
In recent studies, higher intensities
of TENS were shown to be more
effective in reducing pain.1215,22,67
The intensity of stimulation was positively correlated with the change in
PPT produced by TENS.13,14 Another
variable that may have influenced
our results is the fact that we did not
continuously adjust the stimulation

over time, as is common in clinical

practice. Titrating TENS intensity
upward during treatment increased
hypoalgesia in healthy controls.67
Finally, LF-TENS may not have been
as effective because we used a lower
pulse duration and a lower intensity
than are commonly used clinically
(ie, motor intensity).45,64 66 The total
current applied with HF-TENS is
greater than that applied with
LF-TENS when the same intensity
and pulse duration are used.
Although LF-TENS is traditionally
delivered at motor intensities, our
earlier work showed that LF-TENS at
a strong sensory intensity produced
effects equivalent to those obtained
with HF-TENS at a strong sensory
intensity.16,25 We also showed
opioid-mediated analgesia at sensory
intensities with both LF-TENS and
HF-TENS.17,20 Therefore, the present
study focused on the effect of frequency delivered at a strong sensory
intensity for both HF-TENS and
LF-TENS.
Blinding of Active and Placebo
TENS
The present study is the first to validate and test the new transient placebo TENS unit in a group of people
with pain. We were able to adequately blind the participants receiving placebo TENS, with 57% correctly identifying the placebo; this
value was not significantly different
from chance (50:50). If blinding had
been ineffective, we would have
expected the percentage correctly
identifying the placebo to be closer
to 100%, like the value obtained for
the active TENS unit. The new placebo TENS unit can completely blind
the experimenter applying TENS,
and we previously showed the complete inability of the examiner to
correctly identify active TENS or
placebo TENS.13,14,22 Adequate blinding is important because earlier
TENS studies used separate instructions for active TENS and placebo

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Transcutaneous Electrical Nerve Stimulation and Osteoarthritis

TENS, and doing so can influence
the expectations of patients and
have a profound effect on treatment
outcomes.68 72 For example, seminal work by Levine and Gordon68
revealed significant analgesia with a
placebo drug given in a completely
blinded manner; the placebo produced analgesia equivalent to that of
low-dose morphine. On the other
hand, negative or neutral instructions resulted in less reduction in
pain after spinal manipulation than
positive instructions.72 By giving the
same instructions, we were able to
show that active TENS in people
with OA produced pain reduction
similar to that produced by placebo
TENS, suggesting that TENS has a
strong placebo effect on OA pain.
It is possible that the initial placebo
effect that occurs with a single treatment is reduced with repetitive
TENS. In support of this notion, 10
days of electroacupuncture or 2
weeks of TENS in people with knee
OA resulted in significant improvements in pain and function.45,73 Furthermore, Marchand et al74 showed a
cumulative effect of active TENS but
not placebo TENS given twice per
week in people with chronic low
back pain. Therefore, future studies
should examine the effects of repetitive active TENS and transient placebo TENS when the experimenter
applying TENS also is blinded with
regard to group.
In the present study, participants
were able to correctly identify active
TENS 92% of the time. We previously
reported similar responses to active
TENS in healthy controls.13 Despite
participants knowing that they
received active TENS, there was no
difference between active TENS and
placebo TENS in subjective pain rating. Blinding of an electrical modality such as TENS has always been
difficult, and few studies have
reported blinding of active TENS.

908

Physical Therapy

Clinical Implications
In summary, the present randomized
clinical trial examined the effects of
single treatments of HF-TENS and
LF-TENS on knee OA pain and function. The use of various outcome
measures, different frequencies, and
an improved placebo provided
insight for the management of knee
OA pain with TENS. We pilot tested
a series of outcome measures
designed to parallel and validate animal models of TENS and to test the
effects of TENS in a true double-blind
manner. Using PPT as an objective
measure of pain sensitivity, we
showed that both HF-TENS and
LF-TENS reduced primary hyperalgesia and that only HF-TENS reduced
secondary hyperalgesia in people
with OA. Quantitative sensory testing with cutaneous mechanical and
heat pain measures was not affected
by HF-TENS, LF-TENS, or placebo
TENS, suggesting that TENS has no
effect on cutaneous hyperalgesia.
Alternatively, it is possible that the
participants with OA did not have
cutaneous mechanical and heat
hyperalgesia. All treatments had similar but minimal effects on subjective
pain measures, suggesting a placebo
component of the effect of TENS.
None of the treatments had an effect
on TUG walking times. The TUG
may not be an appropriate functional
outcome measure in people with
early symptomatic OA of the knee
because increases in pain and
decreases in function are minimal.
Future studies should expand outcome measures used in TENS studies
to include not only pain at rest, as
commonly assessed, but also pain
during physical function tasks and
deep-tissue hyperalgesia measures.
The effects of repetitive treatments
and of higher intensities should be
tested in people with painful conditions to further elucidate the most
effective use for TENS.

Dr Rakel, Dr Walsh, and Dr Sluka provided

concept/idea/research design. Ms Vance, Dr
Rakel, Ms Blodgett, Dr Walsh, and Dr Sluka
provided writing. Ms Vance, Dr Rakel, Ms
Blodgett, Dr DeSantana, and Dr Sluka provided data collection. Ms Vance, Dr Rakel, Dr
Amendola, and Dr Sluka provided data analysis. Ms Vance, Dr Rakel, and Ms Blodgett
provided project management. Dr Rakel and
Dr Sluka provided fund procurement and
facilities/equipment. Dr Amendola provided
study participants. Ms Vance, Dr Rakel, and
Ms Blodgett provided clerical support. Ms
Vance, Dr Rakel, Ms Blodgett, Dr DeSantana,
Dr Amendola, Dr Walsh and Dr Sluka provided consultation (including review of manuscript before submission).
The authors thank Shannon Lehman, who
served as the TENS effectiveness coordinator, for assistance with the study. The TENS
units and supplies used in the study were
donated by DJO Inc.
This study was approved by the Human Subjects Institutional Review Board at The University of Iowa.
This study was supported by the National
Institutes of Health (R03-NR010405), a Marsha and Ralph Congdon Faculty Development Fellowship in Acute Care for the
Chronically Ill, and The University of Iowa
Carver College of Medicine.
This trial is registered at ClinTrials.gov:
NCT01354054.
DOI: 10.2522/ptj.20110183

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