Recruiting

Cryotherapy

Sponsor:

University of Texas, El Paso

Code:

NCT07211412

Conditions

Exercise Induced Muscle Damage

Cryotherapy

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Cryotherapy

Eccentric exercise-induced muscle damage

Study Details

Brief summary:

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.

Conditions

Exercise Induced Muscle Damage

Cryotherapy

Study ID

NCT07211412

Start date

Nov 15, 2025

Status verified date

Oct, 2026

Completion date

May 15, 2028

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Inclusion Criteria:

  • apparently healthy
  • normotensive
  • non-smokers (all tobacco products including e-cigarettes)

Exclusion Criteria:

  • Cardiovascular diseases (including hypertension)
  • pregnancy
  • any musculoskeletal injury 6 months prior the study

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control-control

This arm will include no intervention and only functional assessments and blood draws for biomarkers.

placebo comparator: Control

This 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: Cryotherapy

This 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.

Interventions

Cryotherapy

A cold (-5°C) cold-pack for 15 minutes every 24 hours for 5 days

Eccentric exercise-induced muscle damage

3 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.

Primary outcome measure

  • Maximal Voluntary Isometric Contraction (MVIC) [ Time Frame: From enrollment to the end of study at 12 days ]
  • Peak Pressure Threshold (PPT) [ Time Frame: From enrollment to the end of study at 12 days. ]
  • Creatine kinase [ Time Frame: From enrollment to the end of treatment at 5 days ]
  • Interleukin-6 [ Time Frame: From enrollment to the end of treatment at 5 days ]
  • 8-isoprostane [ Time Frame: From enrollment to the end of treatment at 5 days ]

Central Contacts and Locations

Central contacts

Alvaro N Gurovich, PT, PhD

915-747-7248agurovich@utep.edu

Locations

The University of Texas at El Paso, Rehabilitation Sciences Complex

Recruiting

El Paso, Texas, United States, 79968

More Information

Sponsor

University of Texas, El Paso

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • Exercise induced muscle damage
  • Cryotherapy
  • Cold-pack
  • Ice-pack
  • Eccentric exercise
  • Creatine kinase
  • c-reactive protein
  • interlukin-6
  • 8-isoprostane
  • Range of motion
  • Maximal Voluntary Isometric Contraction
  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Texas, El Paso on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.