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.
RCT Entities:
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.
Authors: Tomasz Cudejko; Martin van der Esch; Josien C van den Noort; Judith J M Rijnhart; Marike van der Leeden; Leo D Roorda; Willem Lems; Gordon Waddington; Jaap Harlaar; Joost Dekker Journal: Arthritis Care Res (Hoboken) Date: 2019-07-12 Impact factor: 4.794
Authors: Melanie A Holden; Michael Callaghan; David Felson; Fraser Birrell; Elaine Nicholls; Sue Jowett; J Kigozi; John McBeth; Belinda Borrelli; Clare Jinks; Nadine E Foster; Krysia Dziedzic; Christian Mallen; Carol Ingram; Alan Sutton; Sarah Lawton; Nicola Halliday; Liz Hartshorne; Helen Williams; Rachel Browell; Hannah Hudson; Michelle Marshall; Gail Sowden; Dan Herron; Evans Asamane; George Peat Journal: BMJ Open Date: 2021-03-26 Impact factor: 2.692
Authors: Tomasz Cudejko; Martin van der Esch; Marike van der Leeden; Josien C van den Noort; Leo D Roorda; Willem Lems; Jos Twisk; Martijn Steultjens; James Woodburn; Jaap Harlaar; Joost Dekker Journal: Arthritis Res Ther Date: 2017-12-01 Impact factor: 5.156