Thermal Therapies in the Treatment of Muscle Injuries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorAspetar
About this trial
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
This trial does not accept healthy volunteersQualifiers
Participant reported a sudden event
Acute onset pain located on the posterior thigh
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
Disqualifiers
Chronic condition, diabetes, or immune compromised state
Neurological, cardiovascular, pulmonary, or muscular pathology
Pacemaker wearer
Metallic prosthesis
Trial design
Design model
Parallel
Treatments tested in this trial
Cold water immersion
Other intervention10 sessions of 15-minute Cold water bath (12°C) after the 10 first physiotherapy sessions.
Hot water immersion
Other intervention10 sessions of 30 to 45-minute hot water bath (12°C) after the 10 first physiotherapy sessions.
Physiotherapy only
Other interventionControl group. Patients of this group will follow the classic rehabilitation treatment proposed by the physiotherapist and physician of Aspetar without thermal intervention.
Treatment groups
135 Participants
are divided into 3 treatment groupsGroup A: Hamstring injuries grade 1Experimental treatment 3 interventions
Group B: Hamstring injuries grade 2Experimental treatment 3 interventions
Group C: Hamstring injuries grade 3Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
From enrollment until return to sport (assessed on average up to 6 weeks)2
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)
Time frame
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)3
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.
Time frame
1 year post-RTSSecondary outcomes
1
Self reported pain perception during injury palpation and physical activity (on a visual arbitrary scale 0-10)
Pain perceived by the patient during daily palpation and daily rehabilitation exercises.
Time frame
Daily until return to sport (assessed on average up to 6 weeks)2
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
Muscle activation measured using high density electromyography
Time frame
Weekly until return to sport (assessed on average up to 6 weeks)3
Mediolateral width and anterior/posterior depth of the total injured area (in mm)
Area of the injured site (region of interest) identified on the MRI scan and Ultrasound Scan. Comparison between early and late MRI and US performed during the intervention phase.
Time frame
Study inclusion/return to sport (assessed on average up to 6 weeks)4
Hamstring range of motion using MHFAKE measure (in degrees)
The MHFAKE (maximal hip flexion Active knee Extension) is performed with the patient supine with hip flexed and actively extending the knee until pain tolerance allows. The maximum knee extension angle is measured with a goniometer to assess hamstrings flexibility.
Time frame
Daily until return to sport (assessed on average up to 6 weeks) Source ClinicalTrials.gov
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