Exercise Therapy and Orthoses in Lateral Elbow Tendinopathy: Comparative Effects

Not Applicable

Recruiting

• Conditions: Lateral Epicondylitis

• Registration Number: NCT06735092
• Lead Sponsor: Istanbul University - Cerrahpasa

Brief Summary

The aim of this study is to address the inconsistencies in the literature by investigating the effects of a forearm counterforce brace and a wrist splint, used in addition to exercise therapy, on pain, functionality, and grip strength in individuals diagnosed with lateral elbow tendinopathy, compared to those receiving exercise therapy alone.The findings aim to provide valuable insights into clinical practice by highlighting the roles of both orthosis use and exercise in the treatment of lateral elbow tendinopathy.

Detailed Description

This study will be conducted under the supervision of Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. It is designed as a randomized controlled trial and will include participants diagnosed with lateral elbow tendinopathy who meet the inclusion criteria and agree to participate. These participants will be recruited from the Orthopedics and Traumatology Clinic of Basaksehir Cam and Sakura City Hospital. Participants will be informed about the purpose, procedures, and potential risks of the study, and written informed consent forms will be obtained after the explanation. Following the signing of the informed consent forms, participants will be randomized into three groups:

1. Exercise + Counterforce Forearm Brace Group

2. Exercise + Wrist Brace Group

3. Exercise-Only Group (Control Group)

All participants will follow a standard exercise protocol. The exercises will be carried out twice a week for six weeks and will include an evidence-based combined exercise program consisting of isometric, concentric, and eccentric wrist exercises. The exercises will initially start with free weights of 0.5-1 kg, depending on the patient, with progression achieved through 0.5-1 kg weight increments. For exercises using elastic bands, resistance progression will be managed by selecting a band of higher resistance level. In addition to the exercise therapy, Group 1 participants will use a counterforce forearm brace, while Group 2 participants will use a wrist brace.

Participants will be assessed before the intervention and at the 6th and 12th weeks. A total of 45 patients diagnosed with "lateral elbow tendinopathy" by a specialist physician will be evaluated in the study. Assessments will include:

Sociodemographic characteristics and clinical status using a "Case Assessment Form" Pain levels using the "Numerical Pain Rating Scale (NPRS)" Grip strength and pain-free grip strength using a "Digital Hand Dynamometer" Functional levels using the "Patient-Rated Tennis Elbow Evaluation (PRTEE)" questionnaire developed specifically for lateral elbow tendinopathy Satisfaction with the interventions using the "Global Rating of Change Scale." The collected data will be analyzed using Statistical Package for the Social Sciences (SPSS) software.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-02
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-08-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Being between the ages of 18 and 65,
• Having a diagnosis of unilateral lateral elbow tendinopathy,
• Having at least two of the Thomsen, Maudley's, 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.

Exclusion Criteria

• 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 inflammation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)	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.

Secondary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale (NPRS)	six weeks	The Numeric Pain Rating Scale (NPRS) is a subjective measure used to assess pain intensity. It is a 0-10 scale, where 0 indicates "no pain" and 10 represents "the worst pain imaginable." Patients are asked to rate their pain level based on this scale. A decrease in the NPRS score indicates an improvement or reduction in pain, while an increase suggests worsening pain. It is a simple and widely used tool for monitoring pain in clinical and research settings.

Trial Locations

Locations (1)

Faculty of Health Sciences, Istanbul University - Cerrahpasa; 🇹🇷 Istanbul, Buyukcekmece, Turkey