Clinical Effectiveness of Pulsed Electromagnetic Field Therapy as a Treatment Adjunct to Eccentric Exercise for Achilles Tendinopathy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
This study aims to investigate the clinical effectiveness of PEMF as an adjunct to a program of eccentric exercise for the treatment of Achilles tendinopathy. The study objective is to establish whether PEMF plus eccentric exercise in people with Achilles tendinopathy will improve rehabilitation outcomes compared to eccentric exercise only. This study also investigates the effects of PEMF on pain, functional outcomes, mechanical and morphological properties of tendon among patients with Achilles tendinopathy. Investigators hypothesize that pulsed electromagnetic field therapy is effective in reducing pain, improving functional outcomes, and restoring mechanical and morphological properties of tendons in patients with Achilles tendinopathy.
This study is a double-blinded, randomized controlled trial to investigate the clinical effects of pulsed electromagnetic field therapy (PEMF) for Achilles tendinopathy. Participants will be recruited from the outpatient clinic of the orthopedic and traumatology department at Prince of Wales Hospital. Fifty-four patients aged between 18 and 70 with Achilles tendinopathy will be invited to join this trial after informed consent. Participants will be randomized to any of the 2 groups: the intervention group (n=27; PEMF (Quantum Tx) treatment), and the control group (n=27; sham treatment with dummy exposure to PEMF).
Baseline measurements of all self-reported outcomes, functional outcomes, and ultrasound imaging assessments, such as ankle range of motion, jumping ability, pain level, calf muscle strength, calf muscle endurance, physical activity level, quality of life by SF-36 will be measured.
详细描述
Randomization and blinding Participants will be randomized into 1:1 allocation, blocked randomization with 27 participants in the PEMF group and 27 participants in the sham group. Each allocation will be assigned with a unique RFID (generated during block randomization by the PEMF supplier service) recognizable by the PEMF machine. The participants will be assigned an RFID by which the PEMF or sham treatment will be randomly assigned to the RFID. A biostatistician who does not participate in the recruitment of patients will oversee the randomization. Hence, both participants and the research personnel are blinded, and participants will use the RFID to complete the assigned treatment without knowing which treatment they are receiving.
Intervention The intervention will be held at the Chinese University of Hong Kong. Participants in the intervention group will be exposed to PEMF treatment by a PEMF device (Quantum Tx, Singapore). The active PEMF device does not produce heat or cause any sensation to the tissue which allows the participants to be blinded to the treatment. Participants in the control group will receive a sham exposure with the same PEMF device. The diseased leg will be exposed to PEMF or sham treatment for 10 minutes per session, and the treatment regime will run twice a week for 8 weeks, summing up 16 sessions of PEMF or sham exposure in total.
The procedure of PEMF treatment is shown as follows:
The subject will be seated at a 90 degrees position on a chair. The solenoids of the PEMF device will be adjusted to be over the foot and ankle (Achilles tendon and lower calf muscle).
The options of the appliance will be adjusted to 1.5mT, 10Hz on the diseased leg for 10 minutes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70
- •Tenderness with palpation 2-6 cm above the Achilles tendon insertion on the calcaneus (midportion Achilles tendinopathy)
- •Recurrent complaints in 1 or both Achilles' tendons at rest and/or during exercise for the preceding 3 month
- •Structural changes of the tendon were confirmed via sonographic examination during the initial physical exam
- •Achilles tendinopathy affecting the insertional and mid-portion of the Achilles tendon
- •Clinical symptoms associated with Achilles tendinopathy that do not respond well to conventional conservative treatments before entering the study
- •Informed consent
排除标准
- •History of surgery on the affected lower limb in the past year
- •Mental/physical limitation rendering participant to follow instructions
- •With medical or musculoskeletal problems that could affect the ability to complete assessments (i.e. with walking aids or wheel-chaired)
- •Severe cognitive impairments and neurological disorders that will affect data collection by questionnaires
- •Fractures of the trained body parts within the past 12 months
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Change from baseline to 6 months
The Visual Analogue Scale (VAS) requires participants to rate their pain on a defined scale from 0-10. 0 refers to no pain while 10 refers to severe pain. Lower scores mean a better outcome.
Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A)
时间窗: Change from baseline to 6 months
The Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A) is used to evaluate the clinical severity of patients, monitor the change in symptoms and function following interventions provided for Achilles tendinopathy. The questionnaire contains eight questions, covering three necessary domains: 1) pain, 2) functional status, and 3) activity. The first seven questions have a score out of 10, and question 8 scores a maximum of 30. The minimum value is 0 and the maximum value is 100. Higher scores mean a better outcome. Asymptomatic individuals may score 100 points in VISA-A.
次要结局
- Tendon elasticity(Change from baseline to 6 months)
- Tendon thickness(Change from baseline to 6 months)
- Short Form 36 questionnaire (SF-36)(Change from baseline to 6 months)
- Calf muscle endurance(Change from baseline to 6 months)
- Neovascularity(Change from baseline to 6 months)
- Ankle range of motion(Change from baseline to 6 months)
研究者
Samuel KK Ling
Assistant Professor (Clinical) of Orthopaedics & Traumatology
Chinese University of Hong Kong