Thermal Therapies in the Treatment of Muscle Injuries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Aspetar
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Rate of re-injury
研究概览
简要总结
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.
详细描述
This randomized controlled trial will evaluate the therapeutic benefits of two different thermal therapies (hot and cold) in the management of lower limb muscle injuries. After meeting the inclusion criteria, participants will be randomized depending on 2 parameters influencing RTS time (injury grading and tendon involvement in the injury) to ensure consistency across groups. The injury will be graded from 0 to 4 using the British athletics muscle injury classification. Participants will follow physiotherapy treatment and receive one of the two thermal therapies or none during the duration of their rehabilitation in Aspetar. Additionally, to the physiotherapy treatment, they will be followed by a researcher to test their evolution on multiple variables during each visit.
First visit to Aspetar:
Patients presenting a potential hamstring injury defined as an acute onset of posterior thigh pain will be examined by a sport physician during their first visit to Aspetar. The procedure detailed succinctly thereafter is part of the clinical routine currently used in Aspetar. To establish a diagnosis, the sport physician will question patient history on the origin, time, intensity, location of his pain and physically examine him. A visual inspection with palpation will be performed where the physician will inspect the presence/absence of ecchymosis and palpate to determine an area of tenderness and pain for the patient. Following the palpation inspection, passive and active flexibility tests will be performed for maximal knee extension and hip flexion with active knee extension. Flexibility will then be assessed using goniometers or inclinometer as the point of maximum tolerable stretch of the hamstring muscle.
The patient will be referred to the radiology department to perform an MRI if the clinical examination indicates a potential hamstring injury defined as:
- Localized pain during palpation of hamstring muscle,
- Increasing pain during isometric contraction,
- Localized pain when performing a passive straight leg test. Before performing the MRI and if the suspected event of the injury was less than 7 days before the visit to Aspetar, the lead PI of the research or a co-investigator will come to the eligible patients to explain them in detail the purpose of this study. If willing to participate in the study, the patient will be invited to read and sign the inform consent form of this study. In case of a non-participation in the study, the patient will be free to continue his rehabilitation treatment in Aspetar. An initial clinical investigation form will be filled with the patient information and injury details.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of re-injury
时间窗: 1 year post-RTS
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 to return to sport in days
时间窗: From enrollment until return to sport (assessed on average up to 6 weeks)
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).
Isometric hamstring strength
时间窗: 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)
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 to return to sport in days
时间窗: From enrollment until return to sport (assessed on average up to 6 weeks)
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).
Isometric hamstring strength
时间窗: 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)
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)
Rate of re-injury
时间窗: 1 year post-RTS
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.
次要结局
- 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))
- 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))
- Hamstring range of motion using MHFAKE measure (in degrees)(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))
- 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))