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Exercise Induced Muscle DamageNCT07211412

Acute Cryotherapy on Musculoskeletal Function and Biomarkers

A study testing Cryotherapy and Eccentric exercise-induced muscle damage in people with Exercise Induced Muscle Damage and Cryotherapy, run by University of Texas, El Paso at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Exercise Induced Muscle Damage, Cryotherapy
What is being tested?
Cryotherapy and Eccentric exercise-induced muscle damage
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
15 Nov 2025to 15 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alvaro N Gurovich, PT, PhD contact

915-747-7248

agurovich@utep.edu

United States1 site, 1 recruiting
  • The University of Texas at El Paso, Rehabilitation Sciences Complex

    El Paso, Texas, 79968

    Recruiting

Other trials in United States

About this study

Official title: Effects of Acute Cryotherapy on Musculoskeletal Function and Biomarkers for Inflammation, Oxidative Stress, and Muscle Damage

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.

Read the 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.

Means of several markers (functional and in blood) will be analyzed by 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.

Being tested
Cryotherapy, Eccentric exercise-induced muscle damage
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
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CryotherapyOther

    Also called cold-pack, ice-pack

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

  • Eccentric exercise-induced muscle damageOther

    Also called doms

    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.

Study groups in NCT07211412
Study groupRoleWhat they receive
Control-controlNo interventionThis arm will include no intervention and only functional assessments and blood draws for biomarkers.
ControlPlacebo comparatorThis 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.
Receives: Other: Eccentric exercise-induced muscle damage
CryotherapyActive comparatorThis 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.
Receives: Other: Cryotherapy; Other: Eccentric exercise-induced muscle damage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Voluntary Isometric Contraction (MVIC)

    Laid down on an isokinetic dynamometer system (Humac-Norm, Computer Sports Medicine, inc., Stoughton, MA), participants will be asked to flex their non-dominant arm (pull with their hand) against the dynamometer. They will perform 3 tries with 1 minute between tries and the peak value will be considered the MVIC.

    Measured: From enrollment to the end of study at 12 days

  2. Peak Pressure Threshold (PPT)

    PPT is the application of an algometer, which measure pressure on a specific body point (see figure below), while asking the participant 2 questions: 1) tell me when the pressure becomes pain and 2) how much pain you felt from 0 to 100, where 0 is no pain and 100 is the larger pain you have ever experienced. PPT will be performed over the flexor muscles (biceps brachialis) of the non-dominant arm.

    Measured: From enrollment to the end of study at 12 days.

  3. Creatine kinase

    Blood biomarker of muscle damage. Blood draws will be performed before and 0, 24, 48, 72, and 96 hours after EIMD.

    Measured: From enrollment to the end of treatment at 5 days

  4. Interleukin-6

    Blood biomarker of inflammation. Blood draws will be performed before and 0, 24, 48, 72, and 96 hours after EIMD.

    Measured: From enrollment to the end of treatment at 5 days

  5. 8-isoprostane

    Blood biomarker of oxidative stress. Blood draws will be performed before and 0, 24, 48, 72, and 96 hours after EIMD.

    Measured: From enrollment to the end of treatment at 5 days

Secondary outcomes (3)
  1. Arm girth

    With a flexible tape measure, the perimeter will be measured at the non-dominant arm, on the middle between the shoulder and the elbow.

    Measured: From enrollment to the end of study at 12 days.

  2. Active Range of Motion (ROM)

    Participants will be asked to flex and extend the non-dominant elbow while wearing a wireless range of motion device (electronic goniometer, ActiveForce2, ActiveBody, San Diego, CA) (see picture below). The device will measure the active ROM.

    Measured: From enrollment to the end of study at 12 days.

  3. C-reactive protein

    Blood biomarker of inflammation. Blood draws will be performed before and 0, 24, 48, 72, and 96 hours after EIMD.

    Measured: From enrollment to the end of treatment at 5 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2025
  2. Study start15 Nov 2025
  3. Primary completion15 Dec 2027 (estimated)
  4. Study completion15 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a randomized, double-blind, controlled clinical trial with 3 independent groups.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07211412
Sponsor's protocol ID
2356825
Status last verified
Oct 2026
First submitted
1 Oct 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: I might share un-identified data when submitting manuscripts, if asked to do so.

Publications

  • Qu C, Wu Z, Xu M, Qin F, Dong Y, Wang Z, Zhao J. Cryotherapy Models and Timing-Sequence Recovery of Exercise-Induced Muscle Damage in Middle- and Long-Distance Runners. J Athl Train. 2020 Apr;55(4):329-335. doi: 10.4085/1062-6050-529-18. Epub 2020 Mar 11.

    PubMed 32160058
  • Pooley S, Spendiff O, Allen M, Moir HJ. Comparative efficacy of active recovery and cold water immersion as post-match recovery interventions in elite youth soccer. J Sports Sci. 2020 Jun-Jun;38(11-12):1423-1431. doi: 10.1080/02640414.2019.1660448. Epub 2019 Aug 28.

    PubMed 31456474
  • Rose C, Edwards KM, Siegler J, Graham K, Caillaud C. Whole-body Cryotherapy as a Recovery Technique after Exercise: A Review of the Literature. Int J Sports Med. 2017 Dec;38(14):1049-1060. doi: 10.1055/s-0043-114861. Epub 2017 Nov 21.

    PubMed 29161748
  • Kwiecien SY, McHugh MP, Hicks KM, Keane KM, Howatson G. Prolonging the duration of cooling does not enhance recovery following a marathon. Scand J Med Sci Sports. 2021 Jan;31(1):21-29. doi: 10.1111/sms.13822. Epub 2020 Sep 25.

    PubMed 32901996
  • Sasaki R, Sakamoto J, Kondo Y, Oga S, Takeshita I, Honda Y, Kataoka H, Origuchi T, Okita M. Effects of Cryotherapy Applied at Different Temperatures on Inflammatory Pain During the Acute Phase of Arthritis in Rats. Phys Ther. 2021 Feb 4;101(2):pzaa211. doi: 10.1093/ptj/pzaa211.

    PubMed 33351944
  • Merrick MA, Rankin JM, Andres FA, Hinman CL. A preliminary examination of cryotherapy and secondary injury in skeletal muscle. Med Sci Sports Exerc. 1999 Nov;31(11):1516-21. doi: 10.1097/00005768-199911000-00004.

    PubMed 10589851
  • 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.

    PubMed 35195747
  • Kwiecien SY, McHugh MP. The cold truth: the role of cryotherapy in the treatment of injury and recovery from exercise. Eur J Appl Physiol. 2021 Aug;121(8):2125-2142. doi: 10.1007/s00421-021-04683-8. Epub 2021 Apr 20.

    PubMed 33877402
  • 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.

    PubMed 31377722

Questions about this trial

What is this clinical trial studying?

A study testing Cryotherapy and Eccentric exercise-induced muscle damage in people with Exercise Induced Muscle Damage and Cryotherapy, run by University of Texas, El Paso at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alvaro N Gurovich, PT, PhD (915-747-7248, agurovich@utep.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Voluntary Isometric Contraction (MVIC) (time frame: From enrollment to the end of study at 12 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07211412, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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