Acute Cryotherapy on Musculoskeletal Function and Biomarkers
Part of paid clinical trials in El Paso, Texas.
- Sponsor
- University of Texas, El Paso
- Study ID
- NCT07211412
- Status
- Not Yet Recruiting
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Conditions
- Cryotherapy
- Exercise Induced Muscle Damage
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 30 Years
- Healthy Volunteers
- Accepted
Interventions
- Cryotherapy — OTHERA cold (-5°C) cold-pack for 15 minutes every 24 hours for 5 days
- Eccentric exercise-induced muscle damage — OTHER3 sets of 15 repetitions of eccentric contractions at 80% of 1RM. This is to induced a controlled muscle damage in 2 of the 3 arms.
Study Details
In 2020, Dubois and Esculier proposed a paradigm shift in the acute management of musculoskeletal injuries, advocating for the transition from the traditional PRICE protocol- Protect, Rest, Ice, Compression, Elevation-to the more holistic PEACE \& LOVE framework. This updated model emphasizes Protection, Elevation, Avoiding anti-inflammatories, Compression, and Education, followed by Load, Optimism, Vascularization, and Exercise. Notably, the PEACE \& LOVE approach omits the use of ice, a decision that has sparked considerable debate. While the rationale centers on avoiding interference with the natural inflammatory and regenerative processes, this omission stands in contrast to a substantial body of animal research suggesting that cryotherapy can mitigate secondary tissue injury by reducing inflammation and metabolic activity. Despite its widespread clinical use, human studies have yet to provide conclusive evidence supporting or refuting the efficacy of cryotherapy in acute injury management, leaving clinicians to navigate between tradition, emerging evidence, and evolving philosophies of care. Even though it is important to consider natural inflammation for a better regenerative process, animal models have shown that the original injury can elicit oxidative stress, which will enhance cellular damage (secondary damage) and inflammation. Clinically, it is unknown if this secondary damage would increase functional impairment. Therefore, this proposal will determine if cryotherapy can decrease secondary damage, after exercise-induced muscle damage, and if this decrease is associated to lower inflammation, oxidative stress and functional impairments.
Key Dates
- Start date
- Oct 15, 2025
- Status verified
- Oct 2025
- Primary completion
- May 15, 2026
- Completion
- May 15, 2026
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- No Intervention: Control-controlThis arm will include no intervention and only functional assessments and blood draws for biomarkers.
- Placebo Comparator: ControlThis arm will have eccentric exercise-induced muscle damage on day 0 and then 15-min of room temperature cold-pack immediately after and then for 4 more days every 24 hours.
- Active Comparator: CryotherapyThis arm will have eccentric exercise-induced muscle damage on day 0 and then 15-min of cold (-5°C) cold-pack immediately after and then for 4 more days every 24 hours.
Primary Outcome Measure
Maximal Voluntary Isometric Contraction (MVIC) [ Time Frame: From enrollment to the end of study at 12 days ]
Central Contacts
- Alvaro N Gurovich, PT, PhD915-747-7248
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas at El Paso, Rehabilitation Sciences Complex | El Paso | Texas | 79968 | - |
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