Multicentre Randomised Controlled Trial of Pulsed Electro-Magnetic Field Therapy for Treatment of Midportion Achilles Tendinopathy（EM-MAT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Victorian Institute of Sports Assessment (VISA-A)
研究概览
简要总结
This is a multi-centre, randomised, double-blind, placebo-controlled trial with two parallel groups in a 1:1 allocation to study the efficacy of Pulsed Electromagnetic Field Therapy (PEMF) in patients with mid-portion Achilles tendinopathy. All participants will be randomly divided into two groups: an intervention group (active PEMF and standard rehabilitation exercise) and a control group (sham PEMF and standard rehabilitation exercise). All self-reported, functional, and ultrasound findings will be evaluated by the investigator at baseline assessment, 1-month, 2-month, 3-month, 6-month and 12-month follow-up after initiating the intervention.
The researcher will obtain written consent from all participants before the start of this study. All eligible participants will be informed about this study and given enough time to consider whether or not to participate; the clinician/research staff will answer all questions asked by the participants. The trial will be conducted in accordance with the Declaration of Helsinki and the ICH-GCP. Clinical research ethics approval for the trial will be obtained from the Joint Clinical Research Ethics Committee of The Chinese University of Hong Kong. All participants will be recruited from the clinics and centres of the participating institutions.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18 years of age)
- •Clinical diagnosis of mid-Achilles tendinopathy
- •VISA-A score of <60
- •Ultrasound evidence of Achilles tendinopathy (thickening >7mm)
排除标准
- •Previous invasive treatment to the Achilles tendon (e.g. rupture repair, PRP injection etc)
- •Contraindication to PEMF (e.g. pregnancy, pacemakers)
- •Physical or psychological comorbidities impairing the ability to complete assessments (eg neurological deficits etc.)
研究组 & 干预措施
PEMF Therapy + Exercise
干预措施: PEMF (Device)
PEMF Therapy + Exercise
干预措施: Alfredson eccentric training program (Behavioral)
sham Therapy + Exercise
干预措施: Alfredson eccentric training program (Behavioral)
结局指标
主要结局
Victorian Institute of Sports Assessment (VISA-A)
时间窗: Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention
The primary outcome measure will be the Victorian Institute of Sport Assessment (VISA-A) questionnaire, available in either the original English or validated Chinese version, depending on the participant's native language. This specific scoring system developed for the Achilles tendon is the most widely used score for clinical Achilles research. The VISA-A is scored on a scale of 0 to 100; lower scores indicate more severity of symptoms, while a score of 100 indicates a healthy and pain-free Achilles tendon.
次要结局
- Numeric Pain Rating Scale (NPRS)(Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention)
- Foot and Ankle Outcome Scores (FAOS)(Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention)
- Achilles tendon resting angle (ATRA)(Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention)
- Tendon thickness(Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention)
- Tendon cross sectional area(Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention)
- Tendon vascularity(Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention)
- Tendon elasticity(Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention)
- Calf muscle strength(Baseline;2-month;3-month;6-month;12month follow-up after initiating the intervention)
研究者
Samuel KK Ling
Clinical Assistant Professor of Orthopaedics and Traumatology, CUHK Head of the Foot and Ankle Team / Honorary Associate Consultant, Prince of Wales Hospital Specialist in Orthopaedics and Traumatology, CUHK Medical Centre
Chinese University of Hong Kong