Effectiveness of Capacitive and Resistive Energy Transfer Therapy in Patients With Lateral Epicondylitis: A Sham-Controlled, Double-Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
研究概览
简要总结
This prospective, randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy of Capacitive and Resistive Energy Transfer (TECAR) therapy in patients with lateral epicondylitis. Participants will be randomly assigned to either a TECAR plus exercise group or a sham TECAR plus exercise group.
Both groups will receive a standardized home exercise program including elbow and wrist range-of-motion, stretching, eccentric strengthening, and handgrip strengthening exercises. The TECAR group will additionally receive active TECAR therapy, while the control group will receive sham TECAR treatment using the same device and treatment protocol without therapeutic energy delivery.
Outcome assessments will be performed by a blinded evaluator at baseline, immediately after treatment, and at 1- and 2-month follow-up visits. The study aims to determine whether TECAR therapy provides additional benefits in pain relief, functional improvement, and clinical outcomes when combined with exercise therapy in patients with lateral epicondylitis.
详细描述
This study is planned as a prospective, randomized, double-blind, sham-controlled clinical trial involving patients diagnosed with lateral epicondylitis who present to the Physical Medicine and Rehabilitation Outpatient Clinic of Gaziantep City Hospital.
Participants will be randomly allocated into two groups using a computer-generated randomization method:
- Group 1: TECAR therapy + exercise group
- Group 2: Sham TECAR therapy + exercise group
All participants in both groups will receive a home-based exercise program consisting of elbow and wrist range-of-motion exercises, stretching exercises, eccentric strengthening exercises, and handgrip strengthening exercises. The exercise program will be explained in detail by a physiotherapist, and participants will be instructed to perform each exercise 10 repetitions, three times daily, throughout the treatment period. Adherence to the exercise program will be monitored through weekly telephone follow-ups and daily exercise log sheets completed by the participants at home. Compliance with regular splint use will also be monitored.
Outcome assessments will be conducted by a blinded evaluator at baseline, immediately after completion of treatment, and at the 1st and 2nd months following treatment.
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 (Participant, Outcomes Assessor)
盲法说明
This study employs a double-blind design in which both participants and outcome assessors are blinded to treatment allocation. Participants will receive either active TECAR therapy or sham TECAR therapy using the same device, applicator, treatment duration, and treatment procedures. The sham intervention will mimic the active treatment without delivering therapeutic energy. Outcome assessments will be performed by an independent evaluator who will remain unaware of group allocation throughout the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with lateral epicondylitis who have experienced elbow pain for at least 6 weeks and have at least two positive provocative tests (Cozen's, Mill's, or Maudsley's test).
- •Age between 18 and 65 years.
- •Unilateral pain and tenderness over the lateral epicondyle lasting longer than 6 weeks.
- •Clinically diagnosed lateral epicondylitis.
- •No cognitive impairment.
- •Willingness to participate and provide informed consent.
排除标准
- •History of interventional injection to the affected elbow within the previous 3 months.
- •Receipt of physical therapy for the affected elbow within the previous 3 months.
- •Regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) within the previous 2 weeks.
- •History of fracture or surgery involving the affected elbow.
- •Presence of a chronic inflammatory disease.
- •History of malignancy.
- •Active infection.
- •Pregnancy.
- •Presence of a cardiac pacemaker or other electronic implant.
- •Coagulation disorders.
- •Cervical radiculopathy, entrapment neuropathy, or peripheral nerve injury.
- •Body mass index (BMI) ≥ 35 kg/m².
研究组 & 干预措施
TECAR Therapy + Exercise
Participants will receive active TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis.
干预措施: TECAR Therapy + Exercise (Device)
Sham TECAR Therapy + Exercise
Participants will receive sham TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis.
干预措施: Sham TECAR Therapy + Exercise (Device)
研究者
Merve Önoğul Özmen
Consultant
Gaziantep City Hospital