NCT07045129 Thermal Therapies in the Treatment of Muscle Injuries
| NCT ID | NCT07045129 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aspetar |
| Condition | Hamstring Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2025-09-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Participant reported a sudden event * Acute onset pain located on the posterior thigh and/or rectus femuris injury * 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 o rectus femuris * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07045129 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Hamstring Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07045129 currently recruiting?
Yes, NCT07045129 is actively recruiting participants. Contact the research team at marco.cardinale@aspetar.com for enrollment information.
Where is the NCT07045129 trial being conducted?
This trial is being conducted at Doha, Qatar.
Who is sponsoring the NCT07045129 clinical trial?
NCT07045129 is sponsored by Aspetar. The trial plans to enroll 135 participants.