Thermal Therapies in the Treatment of Muscle Injuries

NCT07045129 | Not Yet Recruiting

• 1 other identifier: F202401070
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Muscle strain injuries represent one of the most prevalent injuries in athletes. Despite this high injury prevalence, there is no evidence to support some of the currently used therapeutic strategies. Amongst them, thermal therapies and especially cryotherapy modalities (Ice, Cold water immersion, perfused garments) have been extensively used on soft tissue injuries to reduce pain perception and decrease inflammation. However, recent findings in humans and in animals have reported conflictual results on the effects of cold on muscle regeneration. On the other hand, recent studies in humans suggest that passive heat exposure can impact positively muscle protein synthesis, mitochondrial content and muscle torque in injured, immobilized and healthy participants. Furthermore, preliminary results from our group have shown a faster removal of muscle damages from the muscle and suggest a better muscle regeneration after a localized heat exposure. As such, our preliminary results confirmed that local heating may represent a promising tool to accelerate muscle regeneration. This randomized controlled trial will investigate the therapeutic effect of two thermal interventions (Hot or cold-water immersion) in the management of acute lower limbs muscle injuries. 135 patients will be distributed in a counterbalanced way into 3 groups: Hot, Cold and Control. All the groups will receive the same physiotherapy treatment. The thermal intervention will consist in 10 sessions of either, 60-minute hot water bath (42°C) for the hot group or, 15-minute Cold water bath (12°C) for the cold group realized after the 10 first physiotherapy session. All thermal interventions will be performed after the testing and physiotherapy treatment.

Conditions

Hamstring Injuries; Hamstring Muscle Repair; Hamstring Muscles; Hamstring Rupture; Muscle Tear

Keywords

muscle injury; muscle injuries; hamstring; muscle repair; regeneration; muscle recovery; thermal therapy; CWI; HWI; cold water immersion; hot water immersion; cryotherapy; heat therapy; HD EMG; muscle tear

Outcome Measures

Primary Outcomes (3)

• Time to return to sport in days

  The time necessary for the patient to be considered ready to return safely to full level of training in his sport, outside the control of a physiotherapist from the hospital. Measure: number of days until the patient is discharged to return to sport (in days).

  From enrollment until return to sport (assessed on average up to 6 weeks)

• Isometric hamstring strength

  Weekly evolution of the isometric strength of the hamstring muscles using a custom built dynamometer using a strain gauge measuring Force in prone position and pushing the heel against a fixed resistance. Measure: Peak Force (in Newtons)

  Assessed weekly from the first rehabilitation session after enrolment to the last rehabilitation session before return to sport (assessed on average up to 6 weeks)

• Rate of re-injury

  The number of re-injury occurence in the year following the injury. Re-injury considered as an hamstrings injury occuring in the same side than the original injury. Measure: Every re-injury occurring in the the year following return to sport discharge of the athlete.

  1 year post-RTS

Secondary Outcomes (4)

• Self reported pain perception during injury palpation and physical activity (on a visual arbitrary scale 0-10)

  Daily until return to sport (assessed on average up to 6 weeks)

• Muscle activation of each hamstring muscle (% difference activation in comparison the uninjured leg) as measured by High Density Electromyography. Determining the amplitude of the EMG signal, conduction velocity and motor units recruitment patterns

  Weekly until return to sport (assessed on average up to 6 weeks)

• Mediolateral width and anterior/posterior depth of the total injured area (in mm)

  Study inclusion/return to sport (assessed on average up to 6 weeks)

• Hamstring range of motion using MHFAKE measure (in degrees)

  Daily until return to sport (assessed on average up to 6 weeks)

Study Arms (3)

Hamstring injuries grade 1

EXPERIMENTAL

Grade 1 injury

Other: Cold water immersion; Other: Hot water immersion; Other: Physiotherapy only

Hamstring injuries grade 2

EXPERIMENTAL

Grade 2 injury

Other: Cold water immersion; Other: Hot water immersion; Other: Physiotherapy only

Hamstring injuries grade 3

EXPERIMENTAL

Grade 3 injury

Other: Cold water immersion; Other: Hot water immersion; Other: Physiotherapy only

Interventions

Cold water immersion OTHER

10 sessions of 15-minute Cold water bath (12°C) after the 10 first physiotherapy sessions.

Also known as: CWI, cryotherapy, cold

Hamstring injuries grade 1; Hamstring injuries grade 2; Hamstring injuries grade 3

Hot water immersion OTHER

10 sessions of 30 to 45-minute hot water bath (12°C) after the 10 first physiotherapy sessions.

Also known as: HWI, Heat therapy, hot

Hamstring injuries grade 1; Hamstring injuries grade 2; Hamstring injuries grade 3

Physiotherapy only OTHER

Control group. Patients of this group will follow the classic rehabilitation treatment proposed by the physiotherapist and physician of Aspetar without thermal intervention.

Also known as: rehabilitation

Hamstring injuries grade 1; Hamstring injuries grade 2; Hamstring injuries grade 3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant reported a sudden event
• Acute onset pain located on the posterior thigh
• Clinical diagnosis of an acute muscle injury defined as:
• Localized pain during palpation of the area, Increasing pain during isometric contraction, Localized pain during specific tests.
• MRI confirmed acute muscle lesion grade 1 - 2 - 3 (Pollock et al., 2014) of hamstring muscles
• Available for physiotherapy treatment 4-5 days a week
• MRI of the injury performed in Aspetar within 7 days from the injury
• Available for follow-up
• Compliant with heat or cold-water immersion

You may not qualify if:

• Chronic condition, diabetes, or immune compromised state
• Neurological, cardiovascular, pulmonary, or muscular pathology
• Pacemaker wearer
• Metallic prosthesis
• Skin infection
• Under medication: anti-inflammatory treatment, pain killer drugs, fluoroquinolone antibiotics
• Contraindication to MRI
• Previous verified or suspected lower limb muscle injury for the same leg and the same muscle within the last 6 months
• Chronic lower limb muscle problems on the same muscle
• Grade 0 and 4 muscle injury determined by MRI (Pollock et al., 2014)
• Do not have an intention to return to full sport activity
• Do not want to receive one of the therapies / Noncompliance with heat or cold therapies
• Contraindication to heat
• Do not want to comply with follow-up
• Pregnancy

Sponsors & Collaborators

• Aspetar: lead

Study Sites (1)

Aspetar Orthopaedic and Sports Medicine Hospital

Doha, 0000, Qatar

Location

Related Publications (8)

• D'Souza RF, Figueiredo VC, Markworth JF, Zeng N, Hedges CP, Roberts LA, Raastad T, Coombes JS, Peake JM, Mitchell CJ, Cameron-Smith D. Cold water immersion in recovery following a single bout resistance exercise suppresses mechanisms of miRNA nuclear export and maturation. Physiol Rep. 2023 Aug;11(15):e15784. doi: 10.14814/phy2.15784.

  PMID: 37549955 BACKGROUND

• Roberts LA, Raastad T, Markworth JF, Figueiredo VC, Egner IM, Shield A, Cameron-Smith D, Coombes JS, Peake JM. Post-exercise cold water immersion attenuates acute anabolic signalling and long-term adaptations in muscle to strength training. J Physiol. 2015 Sep 15;593(18):4285-301. doi: 10.1113/JP270570. Epub 2015 Aug 13.

  PMID: 26174323 BACKGROUND

• Peake JM, Roberts LA, Figueiredo VC, Egner I, Krog S, Aas SN, Suzuki K, Markworth JF, Coombes JS, Cameron-Smith D, Raastad T. The effects of cold water immersion and active recovery on inflammation and cell stress responses in human skeletal muscle after resistance exercise. J Physiol. 2017 Feb 1;595(3):695-711. doi: 10.1113/JP272881. Epub 2016 Nov 13.

  PMID: 27704555 BACKGROUND

• McGorm H, Roberts LA, Coombes JS, Peake JM. Turning Up the Heat: An Evaluation of the Evidence for Heating to Promote Exercise Recovery, Muscle Rehabilitation and Adaptation. Sports Med. 2018 Jun;48(6):1311-1328. doi: 10.1007/s40279-018-0876-6.

  PMID: 29470824 BACKGROUND

• Hafen PS, Abbott K, Bowden J, Lopiano R, Hancock CR, Hyldahl RD. Daily heat treatment maintains mitochondrial function and attenuates atrophy in human skeletal muscle subjected to immobilization. J Appl Physiol (1985). 2019 Jul 1;127(1):47-57. doi: 10.1152/japplphysiol.01098.2018. Epub 2019 May 2.

  PMID: 31046520 BACKGROUND

• Nagata I, Kawashima M, Miyazaki A, Miyoshi M, Sakuraya T, Sonomura T, Oyanagi E, Yano H, Arakawa T. Icing after skeletal muscle injury with necrosis in a small fraction of myofibers limits inducible nitric oxide synthase-expressing macrophage invasion and facilitates muscle regeneration. Am J Physiol Regul Integr Comp Physiol. 2023 Apr 1;324(4):R574-R588. doi: 10.1152/ajpregu.00258.2022. Epub 2023 Mar 6.

  PMID: 36878487 BACKGROUND

• Benoit S, Nicolas B, Gregoire MP, Francois B, Abdellah H, Hicham M, Said A, Guillaume C. Hot But Not Cold Water Immersion Mitigates the Decline in Rate of Force Development Following Exercise-Induced Muscle Damage. Med Sci Sports Exerc. 2024 Dec 1;56(12):2362-2371. doi: 10.1249/MSS.0000000000003513. Epub 2024 Jul 4. English, French.

  PMID: 38967392 BACKGROUND

• Kawashima M, Kawanishi N, Tominaga T, Suzuki K, Miyazaki A, Nagata I, Miyoshi M, Miyakawa M, Sakuraya T, Sonomura T, Arakawa T. Icing after eccentric contraction-induced muscle damage perturbs the disappearance of necrotic muscle fibers and phenotypic dynamics of macrophages in mice. J Appl Physiol (1985). 2021 May 1;130(5):1410-1420. doi: 10.1152/japplphysiol.01069.2020. Epub 2021 Mar 25.

  PMID: 33764172 BACKGROUND

MeSH Terms

Conditions

Hyperthermia

Interventions

Cryotherapy; Cold Temperature; Diathermy; Hot Temperature; Rehabilitation

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Hyperthermia, Induced; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Valentin M R Dablainville, Master

CONTACT

+974 44132645; valentin.dablainville@aspetar.com

Marco Cardinale, PhD

CONTACT

marco.cardinale@aspetar.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: July 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

QA (1)