Pilot Study of the Effects of a Heat-Retaining Knee
Sleeve on Joint Pain, Stiffness, and Function in
Patients With Knee Osteoarthritis
STEVEN A. MAZZUCA,1MARK C. PAGE,1RUSSELL D. MELDRUM,1KENNETH D. BRANDT,1AND
Objective. To identify changes in joint pain, stiffness, and functional ability in patients with knee osteoarthritis (OA)
after use of a knee sleeve that prevents loss of body heat by the joint.
Methods. Subjects with symptomatic knee OA (n ? 52) were randomized to 2 treatment groups: verum sleeve (specially
fabricated to retain body heat) or placebo sleeve (standard cotton/elastane sleeve). Subjects wore the sleeve over the more
painful OA knee for at least 12 hours daily for 4 weeks. Pain, stiffness, and functional impairment (Western Ontario and
McMaster Universities Osteoarthritis Index [WOMAC]) in the index knee were measured at baseline and after 4 weeks
of wear, after which sleeve use was discontinued. Telephone followup interviews were conducted 2 and 4 weeks later.
Results. After 4 weeks of sleeve wear, subjects in the active treatment group reported a 16% decrease in mean WOMAC
pain score relative to baseline (P ? 0.001). Those who wore the placebo sleeve reported a 9.7% decrease from baseline
(P ? 0.002). The difference between treatment groups was not statistically significant (P ? 0.12). However, it was found
that the 12 subjects who believed correctly that they had received the verum sleeve reported a highly significant decrease
in WOMAC pain score (–27.5% relative to baseline, P ? 0.0001). In comparison, subjects who received the verum sleeve
but believed they had received the placebo sleeve exhibited only a marginally significant improvement in pain (–13.0%
relative to baseline, P ? 0.07). In the placebo group, the modest improvement in pain scores appeared unrelated to the
subject’s impression of the type of sleeve worn.
Conclusion. This pilot study was insufficiently powered to be a definitive trial of the heat-retaining sleeve. Given the
magnitude of changes in knee pain in the active treatment group, heat retention merits further scientific investigation as
a treatment modality for patients with knee OA.
KEY WORDS. Osteoarthritis; Heat therapy; Nonpharmacologic treatment.
The pain associated with osteoarthritis (OA) may be due to
stretching of the joint capsule, microfractures of subchon-
dral bone, medullary hypertension, synovitis, muscle
spasm, or other forms of soft-tissue rheumatism (e.g., bur-
sitis, tendinitis) (1). Nonpharmacologic measures, which
typically include education of the patient in principles of
joint protection, exercise, weight reduction (if the patient
is obese), orthotics, ambulatory assistive devices, and ther-
mal modalities (e.g., a heating pad or ice pack), are the
keystone of symptomatic therapy for patients with knee
OA (2,3). Pharmacologic agents, such as analgesics and
nonsteroidal antiinflammatory drugs (NSAIDs), augment
the benefits of the nonpharmacologic modalities.
The efficacy of thermal modalities in treatment of OA
pain is supported, in large part, by clinical trials of effec-
tive multifocal self-care interventions for OA patients that
have included guidelines for heat and cold application
among an array of nonpharmacologic treatment modalities
(4–6). A recent placebo-controlled trial has shown that an
elastic wrap for the lumbar region, made of infrared-reflec-
tive material that prevents loss of body heat, reduced com-
plaints of low back pain (7). Other researchers have found
Supported in part by a grant from Spine-Issimus, Ltd.
Materials used in this research were manufactured by
Spine-Issimus, Ltd., Saphron Walden, UK.
1Steven A. Mazzuca, PhD, Mark C. Page, MD, and Russell
D. Meldrum, MD, Kenneth D. Brandt, MD: Indiana Univer-
sity School of Medicine, Indianapolis, Indiana;
Petty-Saphon, PhD: Spine-Issimus, Ltd., Saffron Walden,
Address correspondence to Steven A. Mazzuca, PhD, In-
diana University School of Medicine, Department of Medi-
cine, Rheumatology Division, Long Hospital Room 545,
1110 W Michigan Street, Indianapolis, IN 46202-5100. E-
Submitted for publication March 4, 2003; accepted in
revised form January 2, 2004.
Arthritis & Rheumatism (Arthritis Care & Research)
Vol. 51, No. 5, October 15, 2004, pp 716–721
© 2004, American College of Rheumatology
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