Acute Cryotherapy on Musculoskeletal Function and Biomarkers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorUniversity of Texas, El Paso

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

apparently healthy

normotensive

non-smokers (all tobacco products including e-cigarettes)

Disqualifiers

Cardiovascular diseases (including hypertension)

pregnancy

any musculoskeletal injury 6 months prior the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cryotherapy

    Other intervention

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

  • Eccentric exercise-induced muscle damage

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Control-controlNo intervention 0 interventions
Group B: ControlPlacebo comparator 1 intervention
Group C: CryotherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
From enrollment to the end of treatment at 5 days

Secondary outcomes

1

Arm girth

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

Time frame
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.

Time frame
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.

Time frame
From enrollment to the end of treatment at 5 days.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: