Cryotherapy associated with tailored land-based exercises for knee osteoarthritis: a protocol for a double-blind sham-controlled randomised trial.

INTRODUCTION: There is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA). Cryotherapy is widely used in rehabilitation as an adjunct treatment due to its effects on pain and the inflammatory process. However, disagreement between KOA guidelines remains with respect to its recommendation status. The aim of this study is to verify the complementary effects of cryotherapy when associated with a tailored therapeutic exercise protocol for patients with KOA. METHODS AND ANALYSIS: This study is a sham-controlled randomised trial with concealed allocation and intention-to-treat analysis. Assessments will be performed at baseline and immediately following the intervention period. To check for residual effects of the applied interventions, 3-month and 6-month follow-up assessments will be performed. Participants will be community members living with KOA divided into three groups: (1) the experimental group that will receive a tailored therapeutic exercise protocol followed by a cryotherapy session of 20 min; (2) the sham control group that will receive the same regimen as the first group, but with sham packs filled with dry sand and (3) the active treatment control group that will receive only the therapeutic exercise protocol. The primary outcome will be pain intensity according to a Visual Analogue Scale. Secondary outcomes will be the Western Ontario & McMaster Universities Osteoarthritis Index; the Short-Form Health Survey 36; the 30-s Chair Stand Test; the Stair Climb test; and the 40-m fast-paced walk test. ETHICS AND DISSEMINATION: The trial was approved by the Institutional Ethics Committee of Federal University of São Carlos, São Paulo, Brazil. Registration approval number: CAAE: 65966617.9.0000.5504. The results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03360500.

Short-term cryotherapy did not substantially reduce pain and had unclear effects on physical function and quality of life in people with knee osteoarthritis: a randomised trial.

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.