C L I N I C A L F E AT U R E S
Continuous Low-Level Heatwrap Therapy
Relieves Low Back Pain and Reduces Muscle
Stiffness
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Jill Stark, DPM 1
Jerrold Petrofsky, PhD, JD 2
Lee Berk, DrPH 2,3
Gurinder Bains, MD, PhD 2
Shijie Chen, PhD 4
Geraldine Doyle, PhD 5
1
Pfizer Consumer Healthcare,
For personal use only.
Madison, NJ; 2Department of Physical
Therapy, Loma Linda University, Loma
Linda, CA; 3Department of Pathology
and Human Anatomy, Loma Linda
University, Loma Linda, CA; 4Global
Biometric Sciences, Bristol-Myers
Squibb, Pennington, NJ; 5Independent
Consultant, Chatham, NJ
Correspondence: Jill Stark, DPM,
Senior Director,
Global Pain Franchise,
Pfizer Consumer Healthcare,
5 Giralda Farms,
Madison, NJ 07940.
Tel: 973-660-5234
Fax: 973-660-8480
E-mail: jill.stark@pfizer.com
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DOI: 10.3810/psm.2014.11.2090
Abstract
Background: Low back pain is a common and costly health care problem. This pilot study
evaluated the sensitivity of the 2-stopwatch and Paris plinth methodologies for assessing time-
to-onset of pain relief and flexibility, respectively, with continuous, low-level heatwrap therapy.
Research Design and Methods: Subjects aged 18 to 55 years with at least moderate baseline
acute low back pain were randomly assigned to either heatwrap or oral placebo for 8 hours.
Unheated wrap (sham) and oral ibuprofen were included for blinding purposes only. Results:
Sixty-one subjects were randomly assigned to either heatwrap (n = 26), oral placebo (n = 25),
sham wrap (n = 5), or oral ibuprofen (n = 5). Median time to confirmed first perceptible pain relief
and to meaningful pain relief were significantly shorter for the heatwrap group compared with
those assigned to oral placebo (96.5  vs . 240.0 min and 215.7  vs . 240.0 min, respectively;
P , 0.05 for both). Among subjects receiving the heatwrap, 53.8% reported first perceptible and
meaningful relief, compared with 28.0% receiving oral placebo. Subjective measures of pain
relief, back stiffness, and global evaluation were more sensitive in detecting treatment differ-
ences than the plinth assessments of flexibility, range of motion, and pain. Three adverse events
were reported as mild in severity and considered unrelated to study treatment. Conclusions:
The 2-stopwatch methodology is a viable approach for assessing onset of analgesia in low back
pain; however, the plinth may not be a reliable method for assessing flexibility. Consistent with
published studies involving much larger sample sizes, the heatwrap provided significantly faster
and sustained pain relief than oral placebo in subjects with acute low back pain. Clinical Trial
Identifier: NCT01045993.
Keywords: low back pain; stopwatch methodology; heatwrap; heat therapy; analgesia;
rehabilitation
Introduction
Worldwide, low back pain (LBP) is a common medical problem that causes pain, dis-
ability, and economic loss. On a global scale, LBP has increased from the 12th leading
cause of disability-adjusted life years in 1990 to the 7th in 2010.1 Between 58% and
84% of the population is affected by LBP at some point in their lifetime.2 Men and
women are equally affected by LBP, and prevalence increases with age.3 Low back
pain can be defined as acute (lasting , 4 weeks) or subacute/chronic (lasting . 4
weeks).4 The cause of pain is classified as nonspecific in most (∼90%) individuals
presenting with acute LBP.2 According to the World Health Organization, acute LBP
affects 20% to 44% of the working population annually and reoccurs in up to 85% of
 Stark et al
affected individuals.4 In the United States, LBP is the leading
cause of work-related disability in adults aged , 45 years,
the second most common painful condition reported after
headache, and the fifth most common reason for primary
care office visits.3,5
Although LBP is a leading reason for health care provider
visits, many affected individuals never seek medical care. In
a random telephone survey of North Carolina residents, only
39% of persons with LBP sought medical care.6 Many indi-
viduals may not seek guidance from health care professionals
for LBP because episodes are typically brief. A systematic
review that included 15 studies evaluating LBP showed that
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rapid improvements in pain (mean reduction, 58% of initial
scores), disability (58%), and return to work (82% of those
initially out from work) typically occurred within 1 month.7
However, most patients (73%) had $ 1 recurrence within
12 months.
Given the high prevalence of LBP, it is not surprising
that this condition is associated with a substantial cost. In
2004, the estimated annual direct cost of treating LBP in
the United States was $193.9 billion, which is an average
of $5923 for each of the 32.7 million persons affected.8 In
addition, annual indirect costs for lost wages resulting from
For personal use only.
LBP were estimated at $22.4 billion for 2000 to 2004.8 Other
countries are also faced with similar substantial economic
burden associated with LBP.9–11
Guidelines from the American College of Physicians
(ACP)/American Pain Society (APS) recommend several
treatment options for the management of episodes of LBP.12
Initial treatment for individuals with mild to moderate LBP
and no substantial functional impairment is self-care, which
includes education, advice to remain active, and the applica-
tion of topical heat therapy. Based on treatment guidelines,
insufficient evidence exists to recommend the application of
cold packs as a self-care option.12 For individuals with mod-
erate to severe LBP and evidence of substantial functional
impairment, first-line pharmacotherapy options include over-
the-counter (OTC) oral analgesics, such as acetaminophen
or nonsteroidal anti-inflammatory drugs (NSAIDs). The
goal of treatment is pain relief, allowing for a rapid return
to normal activities.
Because of the considerable pain and disability associ-
ated with episodes of LBP, time-to-onset of pain relief and
improvement in flexibility are important factors to consider
when evaluating treatment options. Currently, however, there
is a lack of reproducible clinical models for evaluating these
factors in individuals with LBP using heatwrap therapy.
The 2-stopwatch methodology has been successfully used
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in models of pain associated with oral surgery and t­ension
headache as a means of determining time-to-onset of anal-
gesic effect.13–17 This methodology uses 2 stopwatches that
patients are instructed to stop sequentially: when they experi-
ence first perceptible pain relief and when they experience
meaningful pain relief. The Paris plinth has been used in
open-label studies in models of LBP and heatwrap therapy
to assess flexibility; however, this methodology has not
been used in randomized, controlled clinical trials. A plinth
device measures 3 separate movements, including extension,
side-to-side movement, and rotation. The primary objec-
tives of this pilot study were to evaluate the stopwatch and
plinth methodologies in assessing the treatment of LBP with
continuous low-level heatwrap therapy compared with oral
placebo over approximately 8 hours of treatment. A second-
ary objective was to assess the efficacy and tolerability of
continuous low-level heatwrap therapy in a population with
acute LBP.
Materials and Methods
This was a single-center, single-dose (single wrap wear
occasion), randomized, single-blind (investigator), sham-
controlled, placebo-controlled, parallel group, pilot study.
Subjects were recruited via advertising. The study protocol
was reviewed and approved by an institutional review
board before study initiation, and all subjects provided
written informed consent before any study procedures were
performed.
Participants
Men and women aged 18 to 55 years (inclusive) in generally
good health with acute nonspecific LBP were recruited for
the study. To qualify for study participation, subjects were
required to have a baseline LBP severity score of at least
moderate intensity ($ 2 on a 6-point categorical scale). In
addition, the primary muscular LBP must have been atrau-
matic in origin (eg, no traumatic injury within 48 hours of
enrollment) and not caused by, or related to, any clinically
significant medical diseases indicative of a pathologic
cause of LBP. To be eligible for inclusion, subjects must
have answered “Yes” to the question, “Do the muscles in
your low back hurt?” at the screening and baseline visits.
Subjects were required to refrain from using any pharmaco-
logic treatments (oral or topical), physical interventions, or
alternative therapies other than the study treatment provided
that may potentially confound the evaluation of efficacy
during the study treatment period. Female subjects were
required to have negative urine pregnancy tests at s­ creening

and baseline and to agree to use an acceptable method of
birth control.
Subjects with any serious medical diseases were excluded
from the study at the investigator’s discretion. Subjects were
excluded if they had any evidence or history of radiculopathy
(eg, sciatica extending below the knee [numbness, tingling,
shooting pain]) or other neurologic deficits (eg, abnormal
straight-leg raising test, patellar reflexes, bowel and/or
bladder function); history of back surgery; fibromyalgia;
diabetes mellitus; peripheral vascular disease; osteoporosis;
gastrointestinal ulcers; gastrointestinal bleeding or perfora-
tion; renal disease; pulmonary edema; cardiomyopathy; liver
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disease; intrinsic coagulation defects; bleeding diseases; or
anticoagulant therapy (eg, warfarin). Subjects were also
excluded if they had any skin lesions (eg, rash, bruising,
swelling, irritation, laceration, excoriation, ulceration) on the
lumbar region. Subjects currently using β-adrenergic block-
ing agents, antidepressant medications, or supplements with
central nervous system effects, or who used short- or long-
acting analgesic medications within 24 or 48 hours before
enrollment, respectively, were also excluded. Additional
exclusion criteria were a history of alcohol and/or drug abuse,
involvement in active litigation or a worker’s compensation
For personal use only.
claim involving low back disability, back pain daily for . 3
consecutive months, or hypersensitivity to heat or NSAIDs.
Treatment
Subjects who met inclusion/exclusion criteria were random-
ized to 1 of 2 primary efficacy groups: heatwrap (ThermaCare
Lower Back/Hip HeatWrap; Pfizer Consumer Healthcare,
Madison, NJ) or oral placebo. The heatwrap secures around
the lumbar region of the torso and heats to approximately
104°F (40°C) within 30 minutes of exposure to air, and main-
tains this temperature continuously for $ 8 hours of wear.18
For blinding purposes only, a small number of subjects were
randomly assigned to 1 of 2 blinding groups: unheated sham
wrap or oral ibuprofen 2 × 200 mg (Advil; Pfizer Consumer
Healthcare, Madison, NJ). The treatment period was 8 hours.
Members of the site staff placed either the heated or sham
wraps on the lower backs of subjects randomly assigned to
these 2 groups. Heated wraps and sham wraps were applied
within 5 minutes of unsealing the pouch. Subjects could
adjust their heatwrap or sham wrap for comfort during the
study. Subjects randomly assigned to oral treatment were
provided placebo or ibuprofen and were required to dose the
medication with 240 mL of water. Subjects were permitted
to walk, stand, or sit during the study and were permitted to
perform other sedentary activities, such as reading or ­working
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Heatwrap Therapy for Low Back Pain
on a computer. Subjects were not, however, permitted to lie
down during the treatment period. Acetaminophen caplets
(2 × 500 mg; Tylenol; McNeil Consumer Healthcare, Fort
Washington, PA) were available for subjects requiring rescue
medication.
Assessments
Baseline Assessments
During the screening visit (visit 1), subjects underwent a
brief physical examination that included a medical history,
assessment of vital signs, weight measurement, and (if
appropriate) a urine pregnancy test. Subjects who required
a washout of their topical/oral analgesic/heat therapy were
instructed to return to the site for the baseline assessment
and treatment visit (visit 2). Subjects who did not need a
washout period were permitted to proceed directly to the
baseline assessments. Pretreatment baseline assessments for
efficacy evaluations included (in the order of performance)
pain intensity, back stiffness, Roland-Morris low back dis-
ability, and perceived stress and flexibility (as measured by
the plinth). Subjects with an adequate baseline pain intensity
score ($ 2 on a 6-point categorical scale) were randomized
as described previously.
Efficacy Assessments
Efficacy assessments taken at 0 through 4 hours were com-
pleted in the clinic, and assessments at 5 through 8 hours were
completed on an outpatient basis via individual study diaries.
Subjects were required to return the completed diaries and
used heatwraps (or sham wraps) to the study site staff within
5 days after the treatment day (visit 2). Because this was a
pilot study designed to evaluate the feasibility of assessing
onset of pain relief using the 2-stopwatch methodology, no
efficacy parameter was identified as primary. Efficacy vari-
ables of interest included onset of pain relief, improvement
in pain, improvement in stiffness, improvement in flexibility,
and global assessment of study treatment.
At the time of wrap application/oral treatment adminis-
tration, 2 stopwatches (faces covered) were started. Within
approximately 3 to 4 minutes after application/administration
of treatment, subjects were provided with 1 stopwatch and
were instructed to stop the stopwatch when they felt “first
perceptible” pain relief. Once the first stopwatch was pressed,
subjects received the second stopwatch and were instructed to
stop the stopwatch when they felt “meaningful” pain relief.
Stopwatches were collected at the time subjects pressed
them, at the time of administration of rescue medication,
or at the time the subjects completed the 4-hour in-clinic
 Stark et al
assessments if they had not yet reported first perceptible or
meaningful pain relief.
Pain relief and muscle stiffness were assessed hourly
over the 8-hour treatment period. Pain relief was rated on
a 6-point categorical scale (0 = no relief; 1 = a little relief;
2 = less than half relief; 3 = more than half relief; 4 = a lot of
relief; 5 = complete relief). Total pain relief was calculated as
the time-weighted sum of pain relief scores from 0 through
8 hours (TOTPAR 0–8). Back stiffness was assessed hourly
using a rating scale from 0 (no muscle stiffness) to 100 (most
possible muscle stiffness). Change from baseline in back stiff-
ness was derived by subtracting the score at each postdosing
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time point from the baseline score, so that a higher positive
value was indicative of greater improvement. Change from
baseline in back stiffness scores over 8 hours was calculated
as the time-weighted sum of back stiffness scores from
0 through 8 hours.
Change from baseline in flexibility, as measured by the
plinth, was assessed at 4  hours. Because improved flex-
ibility is a function of improved pain and reflected by an
improved flex angle, the 2  measures were combined to
provide an overall measure of flexibility. An assessment of
left side-to-side flexibility, right side-to-side flexibility, left
For personal use only.
rotation flexibility, right rotation flexibility, and extension
were obtained with the plinth. The overall combined side-
to-side movement flexibility, overall combined rotation
flexibility, and combined extension scores (at maximum;
5° [± 2°] , maximum; and 5° [± 2°] . maximum flexion/
extension) were analyzed. A  global assessment of study
treatment was assessed at 8 hours using a 6-point numeric
scale (0 = very poor; 1 = poor; 2 = fair; 3 = good; 4 = very
good; 5 = excellent).
Safety Assessments
Each subject was observed for adverse events (AEs) and was
required to report any that developed during the course of the
study. If the subject developed a serious AE or abnormality
at any time during the study, they were withdrawn from the
study to receive appropriate care.
Statistical Analysis
The primary efficacy analysis was based on the intent-to-
treat population, which included all randomly assigned sub-
jects who applied/dosed with study product, and provided a
baseline assessment. The only comparison of interest was
between the heatwrap and oral placebo groups. A sample
size of 25 patients in each of these groups was estimated
to be able to detect a 7-unit difference in the TOTPAR
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0–8  score with 80% power (at 0.05  significance level,
2-sided), assuming the variability (sigma) of this param-
eter to be 8.4. All statistical computations were performed
using SAS version 9.2 (SAS Institute, Cary, NC). Statisti-
cally significant treatment differences were declared if the
P value was # 0.05.
The following efficacy assessments were analyzed by
analysis of variance with treatment term in the model:
change from baseline in pain relief at each individual time
point, TOTPAR 0–8, change from baseline in back stiffness
at each individual time point, time-weighted sum of change
from baseline in back stiffness, change from baseline in
4-hour flexibility scores, and the global assessment. For each
parameter, 95% confidence limits for the pairwise treatment
difference were computed using the least squares means and
the corresponding standard error. Time to confirmed first
perceptible pain relief and meaningful pain relief were ana-
lyzed using the proportional hazards regression model with
the treatment term in the model. For both parameters, 95%
confidence limits for the pairwise treatment difference were
computed based on the log hazard ratio and its standard error.
Because this was a pilot study, no protections for multiple
endpoints were made.
The safety analysis population consisted of all subjects
who applied/dosed the study product and had follow-up
data. All treatment-emergent AEs (those that occurred
after wrap application or administration of the study
medication, or existing AEs that worsened after applying/
taking the study product [ie, treatment-emergent signs and
symptoms]) were summarized based on Medical Dictionary
for Regulatory Activities preferred term and system organ
class, and then classified according to their severity (mild,
moderate, or severe) and relationship (related or not) to
study product. For the summary by severity, subjects who
had multiple occurrences of the same AE were classified
according to the worst reported severity. Similarly, for the
summary by relationship to the study product, AEs were
classified according to the “worst” relationship. Fisher’s
exact test was used to compare the incidence rates of AEs
among treatment groups.
Results
Sixty-one eligible subjects were randomly assigned to
either heatwrap (n = 26), oral placebo (n = 25), unheated
sham wrap (n =  5), or oral ibuprofen (n  = 5). Subjects
randomly assigned to the sham wrap and oral ibuprofen
groups were included for blinding purposes only. Data
from the blinding groups were included in all statistical
 Heatwrap Therapy for Low Back Pain

models; however, only the heatwrap versus oral placebo
comparison was statistically evaluated for efficacy. One
subject (randomly assigned to the sham wrap group) dis-
continued after completing the 8-hour study period because
of ineligibility. This subject did not answer “Yes” to the
question, “Do the muscles in your low back hurt” at the
screening and baseline visits.
Demographics and baseline characteristics were generally
similar between the 2 efficacy treatment groups (Table 1).
There were slightly more male subjects (52.5%) than female
subjects (47.5%), and most were white (47.5%) or Asian
(39.3%). The average age, waist circumference, and weight
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as reported on a 100-mm visual analog scale was 49.2 mm
(range, 15.0–100.0  mm). No significant differences were
noted between treatment groups with regard to baseline
measurements of pain intensity or back stiffness.
Pain Relief
The time to confirmed first perceptible pain relief and time
to meaningful pain relief were both statistically significantly
shorter for subjects in the heatwrap group compared with
those in the oral placebo group (median, 96.5 vs . 240.0 min
and 215.7 vs . 240.0 min, respectively; P = 0.046 for both
comparisons; Figure 1). Among subjects who received the

of enrolled subjects was 29.1 years (range, 19.0–55.0 years),
36.4  inches (range, 27.0–49.0  inches), and 78  kg (range,
43.0–116.0 kg), respectively. None of the prior medical con-
ditions reported was expected to confound study results. Most
subjects (72.1%) reported moderate back pain at baseline,
which corresponded to a score of 2 on a categorical scale
of 0 to 5 points. The mean baseline score for back stiffness
heatwrap, 53.8% experienced both first perceptible and mean-
ingful pain relief compared with 28.0% of the subjects who
received oral placebo. The mean pain relief scores over time
for subjects in the heatwrap group were significantly higher
than for those in the oral placebo group at all time points
through the end of the study (hour 1 to hour 8; Figure 2).
In addition, the mean TOTPAR 0–8 was significantly higher

Table 1.  Demographics and Baseline Characteristics

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Efficacy Treatment Groups Blinding Groupsa

Heatwrap Oral Placebo Sham Wrap Oral Ibuprofen Total
(n = 26) (n = 25) (n = 5) (n = 5) (n = 61)
Gender, n (%)
 Male 15 (57.7) 10 (40.0) 4 (80.0) 3 (60.0) 32 (52.5)
 Female 11 (42.3) 15 (60.0) 1 (20.0) 2 (40.0) 29 (47.5)
Race, n (%)
 White 11 (42.3) 10 (40.0) 4 (80.0) 4 (80.0) 29 (47.5)
 Black 1 (3.8) 2 (8.0) 0 0 3 (4.9)
 Asian 11 (42.3) 11 (44.0) 1 (20.0) 1 (20.0) 24 (39.3)
 Other 3 (11.5) 2 (8.0) 0 0 5 (8.2)
Age, y
  Mean (SD) 30.0 (6.0) 28.8 (7.7) 25.6 (5.4) 30.0 (7.2) 29.1 (6.8)
  Median (range) 27.5 (24–48) 27.0 (21–55) 25.0 (19–32) 28.0 (24–42) 27.0 (19–55)
Waist circumference, in
  Mean (SD) 36.8 (4.4) 35.6 (4.4) 37.4 (6.2) 37.6 (3.4) 36.4 (4.4)
  Median (range) 36.0 (30–49) 35.0 (27–45) 37.0 (28–45) 39.0 (32–41) 37.0 (27–49)
Weight, kg
  Mean (SD) 78.9 (17.3) 74.2 (16.6) 87.3 (18.7) 82.9 (18.3) 78.0 (17.2)
  Median (range) 76.5 (51–116) 75.1 (43–114) 84.6 (68–113) 78.8 (62–108) 76.3 (43–116)
Previous medical conditions, n (%)
 Yes 6 (23.1) 2 (8.0) 0 0 8 (13.1)
 No 20 (76.9) 23 (92.0) 5 (100.0) 5 (100.0) 53 (86.9)
Pain intensity, n (%)
  Moderate (2) 19 (73.1) 20 (80.0) 3 (60.0) 2 (40.0) 44 (72.1)
  Moderately severe (3) 7 (26.9) 4 (16.0) 1 (20.0) 3 (60.0) 15 (24.6)
  Severe (4) 0 1 (4.0) 1 (20.0) 0 2 (3.3)
Back stiffness (VAS), mm
  Mean (SD) 45.85 (13.20) 51.24 (20.30) 55.00 (18.70) 50.00 (10.60) 49.15 (16.70)
  Median (range) 40.00 (25–70) 50.00 (15–100) 50.00 (40–85) 50.00 (35–60) 50.00 (15–100)
a
Data from the blinding groups were not included in the final analysis.
Abbreviation: VAS, visual analog scale.

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 Stark et al

Figure 1.  Pain relief. (A) Time to first perceptible pain relief confirmed by meaningful pain relief. (B) Time to meaningful pain relief.
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For personal use only.

P < 0.05.
a

for subjects in the heatwrap group than for those in the oral
placebo group (mean, 22.0 vs 11.5; P , 0.001). No subject
required rescue medication.
Muscle Stiffness
The mean change from baseline in back stiffness scores over
time were significantly higher for subjects in the heatwrap
treatment group compared with those in the oral placebo group
at all time points evaluated except at the 4-hour time point
(Figure 3). The time-weighted sum of change from baseline in
back stiffness scores from 0 through 8 hours was significantly
higher for subjects in the heatwrap group compared with the
oral placebo group (mean, 167.0 vs 74.5; P = 0.002).
Flexibility
No statistically significant difference was seen in most
flexibility assessments evaluated at 4  hours between the
heatwrap and oral placebo treatment groups as measured by
the plinth. There were no statistically significant treatment
differences in flexibility of extension, side-to-side, and
rotation movements between the heatwrap and oral placebo
groups with the exception of maximum (P  =  0.043) and
plus 5° (P = 0.039) measures for rotation. For the change
from baseline in maximum movement angle, the heatwrap
treatment group had numerically higher range of motion
scores compared with the oral placebo group for extension,
side-to-side, and rotation movements; however, none of the

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Figure 2.  Pain relief over time.
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a
Significant compared to placebo at 0.05 level.
b
c
Significant compared to placebo at 0.01 level.
Significant compared to placebo at 0.001 level.
differences were statistically significant. For the change from
baseline in pain assessment, the heatwrap treatment group
had numerically higher scores than the placebo group for all
measures; however, none of the differences reached statistical
significance with the exception of rotation movement at the
plus 5° angle (P = 0.034).
Global Evaluation of Treatment
For personal use only.
The global assessment score was significantly higher for sub-
jects in the heatwrap group compared with the oral placebo
group (mean, 3.4 vs 1.7 on a 0 [very poor] to 5 [excellent]
scale; P , 0.001). Most subjects (84.0%) in the heatwrap
group reported good, very good, or excellent global scores
compared with those in the oral placebo group (16.0%;
Figure 4).
Figure 3.  Back stiffness change from baseline over time.
Significant compared to placebo at 0.05 level.
a plasters or menthol-containing patches, which do not produce
Significant compared to placebo at 0.01 level.
b
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Heatwrap Therapy for Low Back Pain
Safety
Three AEs were reported by 2  subjects during the study,
both in the heatwrap treatment group. Two subjects (7.7%)
reported headaches that resolved spontaneously, and 1 (3.8%)
reported asthma/trouble breathing; however, this was a
­preexisting condition that resolved with an unreported treat-
ment. All reported AEs were mild in severity and considered
by the investigator to be unrelated to study product. No
subject discontinued because of safety-related reasons, and
no deaths, serious AEs, or other clinically important AEs
occurred during the study.
Discussion
Low back pain is a common and costly medical problem
throughout the developed world.2 Although LBP rarely indi-
cates a serious disorder, it is a major cause of pain, disability,
and economic loss.2 Treatment of LBP often involves the use
of OTC products, such as acetaminophen or NSAIDs, each
of which is associated with its own unique benefits, risks,
and costs. Current treatment guidelines for the management
of LBP advise physicians to assess cardiovascular and gas-
trointestinal risk factors before prescribing NSAIDs, and
recommend use of the lowest effective dose for the shortest
treatment period necessary.12 Heat therapy is also included
in the current treatment guidelines as an important option
for the self-management of LBP.12 Heatwraps that provide
continuous low-level heat therapy that penetrates deep into
the muscle are an alternative nonsystemic, nonmedicated
OTC product that has been shown to be effective in relieving
the symptoms associated with LBP.12
The mechanism of action of heat therapy is believed to be
3-fold.19 Heat dilates blood vessels around muscles and joints,
which results in increased oxygen to the damaged cells and
promotes removal of waste products that otherwise build up
in overused muscles and contribute to pain. Heat also helps
relax the muscles, allowing for increased range of motion.
In addition, heat stimulates thermoreceptors in the skin to
decrease the sensation of pain in the brain. Nonmedicated
heatwraps heat the surface of the skin through an exothermic
chemical reaction involving iron, charcoal, sodium chloride,
and water contained in small discs.20 In addition to increasing
the temperature on the surface of the skin, the most exten-
sively studied of these devices also produces a rapid increase
in intramuscular temperature of approximately 1°C over
baseline at a depth of 2 cm for 30 minutes postapplication.20–22
This is in contrast to capsaicin or capsicum-containing back
an increase in intramuscular temperatures.20–22 Numerous
 Stark et al

Figure 4.  Global evaluation of study treatment. Percentage of subjects reporting a global score of Good,Very Good, or Excellent.
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Significantly better than placebo at 0.001 level.

a

clinical studies with this heatwrap have demonstrated the
effectiveness of continuous low-level heat therapy in reliev-
ing pain, muscle stiffness, and disability, and in improving
lateral trunk flexibility in people with LBP.18,23–28 Data have
For personal use only.
nificant improvements for the heatwrap treatment group over
oral placebo. In particular, the improvement in pain relief was
greater in the heatwrap group starting at the 1-hour time point
and was consistently higher than in the oral placebo group

also shown that continuous low-level heatwrap therapy is
more effective than acetaminophen or NSAIDs in relieving
LBP.18,23
This pilot study was designed to evaluate the feasibility
of assessing time-to-onset of pain relief using the 2-stop-
watch methodology in a population with acute LBP treated
with continuous low-level heatwrap therapy compared
with oral placebo. Studies evaluating oral surgery pain and
tension headache pain have successfully used the 2-stop-
watch methodology; however, this is the first LBP study to
evaluate this technique with continuous low-level heatwrap
therapy.13–17 The results of this study showed that using the
stopwatch methodology was an effective means to determine
onset of pain relief in individuals with LBP. The results
showed a faster onset for both first perceptible pain relief
(96.5 vs . 240.0 min) and meaningful pain relief (215.7
vs . 240.0 min) for the heatwrap treatment group compared
with the oral placebo group. The differences were statisti-
cally and clinically significant for both first perceptible and
meaningful pain relief (P = 0.046 for both comparisons) and
demonstrated the sensitivity of the stopwatch methodology
in assessing onset of analgesia in a model of LBP. Other
subjective measures of efficacy, such as the TOTPAR 0–8,
back stiffness over 8 hours, and subject assessment of global
evaluation of study product, all demonstrated statistically sig-
for each of the hourly time points through the end of study.
In addition to assessing onset methodology, this study
was also designed to evaluate the feasibility and sensitivity of
assessing flexibility with the plinth in subjects with LBP treated
with continuous low-level heatwrap therapy. The subjective
measures of pain relief, back stiffness, and global evaluation
were more sensitive in detecting treatment differences as
compared with the plinth assessments of flexibility, range of
motion, and pain during range of motion. Most measures using
the plinth were generally numerically higher for the heatwrap
treatment group compared with the oral placebo group; how-
ever, a high degree of variability in the plinth values was seen
for each of the measures evaluated, and few of the comparisons
between treatment groups reached statistical significance.
Many of the numerical treatment differences were small
enough to offer limited data regarding treatment effectiveness.
The results using the plinth were not consistent with those dem-
onstrated using the various subjective measures also evaluated
in this study. This may have been related to a higher degree
of variability associated with the plinth, possibly because of
multiple clinicians operating the device. Additionally, subjects
found that stretching on the plinth reduced pain. The great-
est variability seemed to occur for the plus 5° and minus 5°
measurements. In future evaluations using the plinth, it may
be feasible to consider just the maximum extension parameter

46 © The Physician and Sportsmedicine, Volume 42, Issue 4, November 2014, ISSN – 0091-3847
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because, although not statistically significant, the results for
this measure were more consistent with those observed with
the subjective measures used in this study.
The overall results of this pilot study were consistent with
earlier studies demonstrating the clinical benefit of continu-
ous low-level heatwrap therapy in subjects with LBP. Nadler
et al26 showed that heatwrap therapy provided significant ther-
apeutic benefits compared with oral placebo in a prospective,
randomized, parallel, single-blind (investigator), multicenter
trial evaluating 219 subjects with acute nonspecific LBP. On
day 1, the heatwrap group had greater pain relief (1.76 ± 0.10
vs 1.05 ± 0.11; P , 0.001), less muscle stiffness (43.10 ±
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1.21 vs 47.60 ± 1.21; P = 0.008), increased flexibility (18.6 ±
0.44 cm vs 16.5 ± 0.45 cm; P = 0.001), and less disability (5.3
vs 7.4; P = 0.0002) compared with placebo.26 In a separate
study, Nadler et al27 also showed that overnight treatment
with continuous low-level heatwrap therapy while sleeping
significantly improved morning pain relief (P = 0.00005) and
daytime pain relief (P , 0.001) compared with oral placebo
in subjects with acute nonspecific LBP (N = 76). Data also
demonstrate that treatment with continuous low-level heat-
wrap therapy for acute LBP is more effective than OTC doses
of ibuprofen (1200 mg/d) or acetaminophen (4000 mg/d).18 In
For personal use only.
this study, subjects (N = 371) treated with the heatwrap had
statistically significantly higher mean day 1 pain relief scores
and extended pain relief (days 3–4) scores compared with
subjects taking ibuprofen (2.00 vs 1.51; P = 0.0007 and 2.61
vs 1.68; P = 0.0001, respectively) or acetaminophen (2.00 vs
1.32; P = 0.0001 and 2.61 vs 1.95; P = 0.0009, respectively).18
The following parameters were also statistically significantly
improved for subjects in the heatwrap group compared with
the ibuprofen or acetaminophen groups: lateral trunk flex-
ibility (P # 0.001 and P # 0.009, respectively), disability
(P = 0.01 and P = 0.0007, respectively), and muscle stiffness
(P = 0.001 vs acetaminophen only).18
Treatment with the air-activated heatwrap was well-
tolerated in the study population. Two subjects reported
3 AEs, all of which were mild in severity and determined
to be unrelated to study treatment. Unlike other forms of
heat therapy, such as electric heating pads and hot water
bottles, which may be inconvenient and do not easily allow
for movement, air-activated heatwraps allow individuals
with LBP to remain mobile and continue their normal daily
activities. These products are soft, flexible, specifically
shaped for the lower back, and convenient to use.20 Current
treatment guidelines stress the importance of remaining
active as a key component to the self-care management of
LBP.12 A Cochrane Database systematic review, included in
© The Physician and Sportsmedicine, Volume 42, Issue 4, November 2014, ISSN – 0091-3847 47
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Heatwrap Therapy for Low Back Pain
the current treatment guidelines, examined 11 randomized or
controlled clinical trials (N = 1963) in which the effectiveness
of advice to stay in bed versus to stay active was evaluated.12,29
High-quality evidence showed that people with acute LBP
who are advised to rest in bed have more pain (standardized
mean difference [SMD], 0.22; 95% CI, 0.02–0.41) and less
functional recovery (SMD, 0.29; 95% CI, 0.05–0.45) than
those advised to stay active.29
This study is limited by its single-blind design. The study
also lacked sufficient power to detect treatment differences
with regard to the novel, objective measures used to assess
flexibility and range of motion. Despite these limitations, it
provides, possibly for the first time, support for the use of the
2-stopwatch method to assess pain relief in acute muscular
LBP. More importantly, from a clinical perspective, it sup-
ports findings from past investigations regarding the clinical
utility of heatwrap therapy in LBP.
Conclusion
Results from this pilot study show that continuous low-level
heatwrap therapy provides faster onset of analgesia com-
pared with placebo in a model of LBP. Results also indicate
that the 2-stopwatch methodology is a viable approach for
assessing the onset of analgesia, but that the plinth may not
be the most reliable or informative approach for assess-
ing flexibility in this setting. The stopwatch methodology
provided a highly sensitive and reliable means of measur-
ing time-to-onset of pain relief with continuous low-level
heatwrap therapy. To the best of the authors’ knowledge,
this is the first study to evaluate this methodology and air-
activated heatwrap therapy in a model of LBP. Addition-
ally, this study supports earlier reports demonstrating the
safety and efficacy of continuous, temperature-controlled
low-level heat therapy for improving symptoms associated
with LBP.
Acknowledgments
Editorial support was provided by Payal N. Gandhi, PhD, at
ProEd Communications, Inc., and John H. Simmons, MD,
at Peloton Advantage. This study was sponsored by
Pfizer Consumer Healthcare, 5 Giralda Farms, Madison,
NJ 07940, USA.
Data from this study were previously presented at the
following meetings: PainWeek, September 8, 2011, Las
Vegas, NV, USA; German Pain Congress (Schmerzkon-
gress), October 5–8, 2011, Mannheim, Germany; American
College of Rheumatology/Association of Rheumatology
Health Professionals Annual Scientific Meeting, November
 Stark et al
7, 2011, Chicago, IL, USA; British Pharmacological Society
(BPS) Winter Meeting, December 14, 2011, London, United
Kingdom.
Conflict of Interest Statement
Lee Berk, DrPH, and Gurinder Bains, MD, PhD, declare
no conflicts of interest. Jill Stark, DPM, is an employee of
Pfizer Consumer Healthcare. Shijie Chen, PhD, and Geraldine
Doyle, PhD, were Pfizer Consumer Healthcare employees at
the time this study was conducted. Jerrold Petrofsky, PhD, JD,
is a consultant for and has received research funding from
Pfizer, Inc.
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