A Double-Blinded, Randomized-Controlled-Trial to Investigate the Effect of Pulsed Electromagnetic Field (PEMF) for Patients With Quadriceps Weakness After Anterior Cruciate Ligament Reconstruction (ACLR)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of peak torque of Isokinetic muscle strength
研究概览
简要总结
In Hong Kong, over 3000 Anterior Cruciate Ligament Reconstructions (ACLR) are performed each year in order to restore knee function after an ACL injury. The ultimate goal of ACLR is to fulfil the return-to-play (RTP) criteria. Despite successful surgery and a demanding rehabilitation process, some athletes still fail to comply to RTP. For those who achieve RTP, 23% of those who return to their sports would suffer a second ACL injury.
Quadriceps muscle strength is one of the key determinants for a patient's successful return- to-play after ACLR. Quadriceps muscle atrophy can persist beyond the completion of the rehabilitation program in almost half the patients and the reason behind this is still unknown. Therefore, there is need to find a more effective way to increase quadriceps strength.
There are emerging evidences showing that pulsed electromagnetic field (PEMF) can modulate mitochondrial activities for muscle gain. PEMF exposure on top of regular exercise training may promote muscle regeneration and tissue healing.
This study aims to conduct a double-blinded, randomized controlled trial to investigate the effects of PEMF treatment during the late postoperative period on quadriceps muscle strength in ACL injured patient. Muscle endurance could only be investigated in late postoperative period. The investigators hypothesize that PEMF treatment is effective to reduce muscle weakness and promote gain in quadriceps muscle strength in ACLR patients.
Based on the aim of this study, adult patients (aged 18-30) with a unilateral ACL injury, total quadriceps muscle volume is equal or morn than 7% deficit on involved leg compared with uninvolved leg, sporting injury with a Tegner score of 7+, both knees without a history of injury/prior surgery will be recruited. To estimate the improvement of patients, Isokinetic muscle assessment, ultrasound imaging and MRI for quadriceps muscle thickness, self-reported outcomes with questionnaires, KT-1000 for knee laxity and biomechanical analysis, Xtreme CT for Bone mineral density will be performed.
To investigate the mechanism of PEMF therapy on increasing quadriceps strength, samples of blood serum will be draw before and after intervention.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
It is doubled blinded, a subject 's specific ID card will be provided for each of the enrolled subject and the investigators don't know whether it is PEMF or Sham treatment for that subject's specific ID card. And the investigator will ask the manufactory about the number of grouping at the end of the study.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-50 with a unilateral ACL injury
- •Sporting injury with a Tegner score of 7+
- •LSI for quadriceps strength <70% of the contralateral leg at 4 months post-up
- •Both knees without a history of injury/prior surgery
排除标准
- •Ages smaller than 18 years old or greater than 50 years old
- •Any concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-op
- •Preoperative radiographic signs of arthritis
- •Metal implants that would cause interference on MRI
- •Non-HS graft for ACLR
- •Patient non-compliance to the rehabilitation program
- •Pregnancy or possibility of pregnancy
结局指标
主要结局
Change of peak torque of Isokinetic muscle strength
时间窗: pre intervention, 4weeks, 8 weeks and 8 months after the commencement of intervention
The peak torque in N will be the single highest repetition value within the 30 repetitions in the isokinetic muscle strength test.
Change of Fatigue index of isokinetic muscle strength
时间窗: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
The Fatigue index (F.I) can be used to calculated the percent decrease for each variable which reflected the muscle endurance.
次要结局
- Single leg hop distance(4weeks, 8 weeks and 8 months after the commencement of intervention)
- Visual Analogue Scale(Before and after 1st - 16th of PEMF treatment)
- Ultrasound imaging muscle thickness(pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention)
- Serum myokine evaluation(pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention)
- Reaming size of the bone(pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention)
- Lysholm knee scoring system(pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention)
- MRI Muscle thickness(pre PEMF intervention and 8 weeks after the commencement of intervention)
- Knee Joint moments(pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention)
- Tegner activity score(pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention)
- International Physical Activity Questionnaire(pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention)
- Passive Knee laxity(pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention)
- Ground reaction force(pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention)
- International Knee Documentation Committee(pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention)
研究者
Prof. Tim-Yun Michael ONG
Clinical Assistant Professor
Chinese University of Hong Kong