Acute Cryotherapy on Musculoskeletal Function and Biomarkers

NCT ID: NCT07211412

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2026-05-15

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.

Detailed Description

This study is a randomized, double-blind, controlled clinical trial with 3 independent groups. One group (control-control or CON-CON) will not exercise and will not have any cryotherapy intervention, a second group (control or CON) will exercise but use a "room temperature" cold-pack, and the cryotherapy group (CRYO) will exercise and receive a cold cold-pack every day for 15-min.

We anticipate to compare means in several markers (functional and in blood) using a two-way analysis of variance (ANOVA, time x condition) where time is before, and 0, 24, 48, 72, 96, and 264 hours after exercise (6 visits) and conditions are CON-CON, CON, and CRYO.

VISIT ONE Before the informed consent process, potential participants will rest for 10 minutes, and their blood pressure will be taken to confirm eligibility. Once eligibility is confirmed, participants will go through the informed consent process. After the participants have signed the informed consent, the participants will be randomly allocated to one of the 3 groups. Then, a blood sample (two 10-ml tubes) from an antecubital vein of the dominant arm will be drawn. After the blood drawn, a set of functional tests ( i.e., arm girth, active range of motion (ROM), peak pressure threshold (PPT), and maximal voluntary isometric contraction (MVIC)) will be performed (the description of each test can be found below). Once the functional tests are performed, participants from the CON-CON group will be dismissed. Participants from the other 2 groups will perform a controlled exercise-induced muscle damage (EIMD) through eccentric exercise (protocol description below). Immediately after the EIMD protocol, participants in the CON group will receive 15-min of a room temperature cold-pack in room RSC 100. Participants in the CRYO group will receive 15-min of a cold cold-pack in room RSC 100. Treatment will be performed by RAs that were not involved in any testing session. After treatment, CON or CRYO, the same set of functional tests will be performed in room RSC 117.

VISIT TWO to FOUR (24, 48, and 72 hours after VISIT 1, respectively) Participants will get a blood draw (two 10-ml tubes) from an antecubital vein of the dominant arm. Then, participants in the CON group will receive 15-min of a room temperature cold-pack in room RSC 100. Participants in the CRYO group will receive 15-min of a cold cold-pack in room RSC 100. Treatment will be performed by RAs that were not involved in any testing session. Participants from the CON-CON group will not have any treatment. Finally, the set of functional tests will be performed.

VISIT FIVE (96 hours after VISIT 1) Participants will get only a blood draw (two 10-ml tubes) from an antecubital vein of the dominant arm. Then, participants in the CON group will receive 15-min of a room temperature cold-pack in room RSC 100. Participants in the CRYO group will receive 15-min of a cold cold-pack in room RSC 100. Treatment will be performed by RAs that were not involved in any testing session. Participants from the CON-CON group will not have any treatment.

VISIT SIX (264 hours after VISIT 1) Participants will get a blood draw (two 10-ml tubes) from an antecubital vein of the dominant arm. Then, the set of functional tests will be performed.

Conditions

Exercise Induced Muscle Damage; Cryotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Control-control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: PLACEBO_COMPARATOR

Eccentric exercise-induced muscle damage

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Cryotherapy

Intervention Type: OTHER

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

Eccentric exercise-induced muscle damage

Intervention Type: OTHER

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.

Interventions

Cryotherapy

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

cold-pack; ice-pack; doms

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas, El Paso

OTHER

Sponsor Role: lead

Responsible Party

Alvaro Gurovich

Professor and Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Texas at El Paso, Rehabilitation Sciences Complex

El Paso, Texas, United States

Countries

United States

Central Contacts

Alvaro N Gurovich, PT, PhD

Role: CONTACT

agurovich@utep.edu

915-747-7248

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Allan R, Malone J, Alexander J, Vorajee S, Ihsan M, Gregson W, Kwiecien S, Mawhinney C. Cold for centuries: a brief history of cryotherapies to improve health, injury and post-exercise recovery. Eur J Appl Physiol. 2022 May;122(5):1153-1162. doi: 10.1007/s00421-022-04915-5. Epub 2022 Feb 23.

Reference Type: BACKGROUND

PMID: 35195747 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 33877402 (View on PubMed)

Dubois B, Esculier JF. Soft-tissue injuries simply need PEACE and LOVE. Br J Sports Med. 2020 Jan;54(2):72-73. doi: 10.1136/bjsports-2019-101253. Epub 2019 Aug 3. No abstract available.

Reference Type: BACKGROUND

PMID: 31377722 (View on PubMed)

Other Identifiers

2356825

Identifier Type: -

Identifier Source: org_study_id