Optimizing soft tissue injury rehabilitation: PEACE & LOVE with vs without cryotherapy-protocol for a sham-controlled randomized trial in acute lateral ankle sprain
Abstract
Background: Acute lateral ankle sprains, especially those affecting the anterior talofibular ligament (ATFL), are one of the most frequent injuries in athletes and active adults. These injuries cause pain, swelling, functional restriction, and high recurrence. The PEACE & LOVE framework discourages the use of cryotherapy, yet ice remains widely used in sports and rehabilitation practice. To date, there is limited high-quality evidence evaluating the effect of cryotherapy within this framework. This trial is designed to investigate whether adding cryotherapy to PEACE & LOVE rehabilitation improves outcomes compared with sham cryotherapy.
Methods: This single-center, parallel-group, sham-controlled randomized clinical trial will include 60 physically active adults (aged 18-40 years) with grade I-II acute lateral ankle sprains sustained within 48 h. Recruitment has not commenced and is planned from March to May 2026. Follow-up assessments will continue through 12 weeks post-randomization. Participants will be randomly assigned (1:1) to receive either PEACE & LOVE plus cryotherapy (0-4 °C, 20 min, three times daily for 72 h) or PEACE & LOVE plus sham cryotherapy (identical packs at ~20-25 °C with insulation). The primary outcome is pain intensity measured by the Numeric Pain Rating Scale (NPRS) at day 7. Secondary outcomes are functional recovery measured by the Lower Extremity Functional Scale (LEFS) at day 14, week 4, and week 12; ankle swelling assessed by figure-of-eight…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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