OBJECTIVE: Does short-term cryotherapy improve pain, function and quality of life in people with knee osteoarthritis (OA)? DESIGN: Randomised controlled trial with concealed allocation, blinded assessment of some outcomes, and intention-to-treat analysis. PARTICIPANTS: People living in the community with knee OA. INTERVENTIONS: The experimental group received cryotherapy, delivered as packs of crushed ice applied to the knee with mild compression. The control group received the same regimen but with sham packs filled with sand. The interventions were applied once a day for 4 consecutive days. OUTCOME MEASURES: Participants were assessed at baseline and on the day after the 4-day intervention period. The primary outcome was pain intensity according to a visual analogue scale. Secondary outcomes were baseline to post-intervention changes according to the Western Ontario and McMaster Universities Osteoarthritis, Knee injury and Osteoarthritis Outcome; Timed Up and Go test; and 30-Second Chair to Stand test. RESULTS:Sixty participants were randomised into the experimental group (n = 30) or the control group (n = 30). Twenty-nine participants from each group completed the trial. The mean between-group difference in change in pain severity was -0.8 cm (95% CI -1.6 to 0.1), where negative values favour the experimental group. This result did not reach the nominated smallest worthwhile effect of 1.75 cm. The secondary outcomes had less-precise estimates, with confidence intervals that spanned worthwhile, trivial and mildly harmful effects. CONCLUSION:Short-term cryotherapy was not superior to a sham intervention in terms of relieving pain or improving function and quality of life in people with knee OA. Although cryotherapy is considered to be a widely used resource in clinical practice, this study does not suggest that it has an important short-term effect, when compared with a sham control, as a non-pharmacological treatment for people with knee osteoarthritis. REGISTRATION: NCT02725047.
RCT Entities:
OBJECTIVE: Does short-term cryotherapy improve pain, function and quality of life in people with knee osteoarthritis (OA)? DESIGN: Randomised controlled trial with concealed allocation, blinded assessment of some outcomes, and intention-to-treat analysis. PARTICIPANTS: People living in the community with knee OA. INTERVENTIONS: The experimental group received cryotherapy, delivered as packs of crushed ice applied to the knee with mild compression. The control group received the same regimen but with sham packs filled with sand. The interventions were applied once a day for 4 consecutive days. OUTCOME MEASURES: Participants were assessed at baseline and on the day after the 4-day intervention period. The primary outcome was pain intensity according to a visual analogue scale. Secondary outcomes were baseline to post-intervention changes according to the Western Ontario and McMaster Universities Osteoarthritis, Knee injury and Osteoarthritis Outcome; Timed Up and Go test; and 30-Second Chair to Stand test. RESULTS: Sixty participants were randomised into the experimental group (n = 30) or the control group (n = 30). Twenty-nine participants from each group completed the trial. The mean between-group difference in change in pain severity was -0.8 cm (95% CI -1.6 to 0.1), where negative values favour the experimental group. This result did not reach the nominated smallest worthwhile effect of 1.75 cm. The secondary outcomes had less-precise estimates, with confidence intervals that spanned worthwhile, trivial and mildly harmful effects. CONCLUSION: Short-term cryotherapy was not superior to a sham intervention in terms of relieving pain or improving function and quality of life in people with knee OA. Although cryotherapy is considered to be a widely used resource in clinical practice, this study does not suggest that it has an important short-term effect, when compared with a sham control, as a non-pharmacological treatment for people with knee osteoarthritis. REGISTRATION: NCT02725047.
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