Investigation of the Effects of Different Types of Orthoses Used in Addition to Exercise Therapy in Lateral Elbow Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
研究概览
简要总结
The aim of this study was to investigate whether adding a forearm counterforce brace or a wrist orthosis to exercise therapy provided additional benefits in pain, functional status, grip strength, and perceived recovery in individuals with lateral elbow tendinopathy, compared with exercise therapy alone.
详细描述
This study was conducted under the supervision of Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. It was designed as a single-centre, three-arm randomized controlled trial and included adults with unilateral lateral elbow tendinopathy who met the eligibility criteria and provided written informed consent. Participants were recruited from the Orthopedics and Traumatology Clinic of Basaksehir Cam and Sakura City Hospital. Participants were informed about the purpose, procedures, and potential risks of the study, and written informed consent was obtained from all participants. Following informed consent, 45 participants were randomly allocated in a 1:1:1 ratio to three groups:
- Exercise-Only Group
- Exercise + Counterforce Forearm Brace Group
- Exercise + Wrist Orthosis Group
All participants received education, activity modification, and the same physiotherapist-led progressive exercise program. Supervised exercise sessions were conducted twice weekly for 6 weeks, followed by a 6-week home exercise program. The exercise program consisted of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights according to individual tolerance, with progression achieved through 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next resistance level. Participants in Group 2 additionally used a counterforce forearm brace, whereas participants in Group 3 additionally used a wrist orthosis.
Participants were assessed at baseline, week 6, and week 12. The primary outcome was the Patient-Rated Tennis Elbow Evaluation (PRTEE). Secondary outcomes included resting and activity pain assessed using the Numeric Pain Rating Scale (NPRS), pain-free and maximum grip strength measured using a digital hand dynamometer, and perceived recovery assessed using the Global Rating of Change (GRC) scale. Sociodemographic and clinical characteristics were recorded using a case assessment form.
The collected data were analyzed using the Statistical Package for the Social Sciences (SPSS).
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
- None (Participant)
盲法说明
The study was an open-label randomized controlled trial. Participants and treating physiotherapists were not blinded to group allocation due to the nature of the interventions. The outcome assessor was blinded to group allocation and performed all baseline and follow-up measurements.
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
- •Being between the ages of 18 and 65,
- •Having a diagnosis of unilateral lateral elbow tendinopathy,
- •Having at least two of the Thomsen, Maudsley, Mill's, or Cozen's tests positive during clinical examination,
- •Experiencing symptoms for at least 3 months,
- •Not having a systemic or chronic illness that would prevent participation in the treatment program.
排除标准
- •A history of trauma or surgery in the relevant elbow and/or wrist,
- •The presence of orthopedic and/or neurological problems in the cervical spine, shoulder joint, or wrist,
- •Participation in a physiotherapy and rehabilitation program for lateral elbow tendinopathy within the last 6 months,
- •Receiving any injections within the last 6 months,
- •Systemic inflammatory disease.
研究组 & 干预措施
Exercise + Forearm Counterforce Brace Group
This group received a combined treatment approach, including exercise therapy alongside the use of a forearm counterforce brace. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises was applied to the participants in this group.
干预措施: Exercise + Forearm Counterforce Brace Group (Other)
Exercise-Only Group
This was the exercise-only group, in which participants received an exercise program without any additional support or devices such as braces. This group was used to assess the effectiveness of exercise alone compared with other interventions involving braces. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises was applied to the participants in this group.
干预措施: Exercise-Only Group (Other)
Exercise + Wrist Orthosis Group
This group received a treatment combining exercise therapy with the use of a wrist orthosis. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises was applied to the participants in this group.
干预措施: Exercise + Wrist Orthosis Group (Other)
结局指标
主要结局
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
时间窗: six weeks
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a self-reported questionnaire designed to measure pain and functional limitations in individuals with lateral epicondylitis (tennis elbow). It consists of 15 items divided into two subscales: pain (5 items) and functional disability (10 items). Each item is rated on a scale from 0 (no pain or difficulty) to 10 (severe pain or difficulty), with a total score range of 0 to 100. Higher scores indicate greater pain and disability, while lower scores reflect improvement. The PRTEE is commonly used to assess treatment outcomes and track patient progress over time.
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
时间窗: Baseline, week 6, week 12; primary endpoint = week 12
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a self-reported questionnaire designed to measure pain and functional limitations in individuals with lateral epicondylitis (tennis elbow). It consists of 15 items divided into two subscales: pain (5 items) and functional disability (10 items). Each item is rated on a scale from 0 (no pain or difficulty) to 10 (severe pain or difficulty), with a total score range of 0 to 100. Higher scores indicate greater pain and disability, while lower scores reflect improvement. The PRTEE is commonly used to assess treatment outcomes and track patient progress over time.
次要结局
- Numeric Pain Rating Scale (NPRS)(six weeks)
- Resting Pain Intensity (Numeric Pain Rating Scale [NPRS])(Baseline, week 6, week 12)
- Activity Pain Intensity (Numeric Pain Rating Scale [NPRS])(Baseline, week 6, week 12)
- Pain-Free Grip Strength(Baseline, week 6, week 12)
- Maximum Grip Strength(Baseline, week 6, week 12)
- Global Rating of Change (GRC)(Week 6, week 12)
研究者
Büşra Kültür
Physiotherapist, MSc
Istanbul University - Cerrahpasa