Exercise Therapy and Orthoses in Lateral Elbow Tendinopathy: Comparative Effects

Investigation of the Effects of Different Types of Orthoses Used in Addition to Exercise Therapy in Lateral Elbow Tendinopathy

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.

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Other: Exercise-Only Group; Other: Exercise + Forearm Counterforce Brace Group; Other: Exercise + Wrist Orthosis Group

Detailed Description

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:

1. Exercise-Only Group
2. Exercise + Counterforce Forearm Brace Group
3. 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).

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Buyukcekmece
    • Istanbul, Buyukcekmece, Turkey (Türkiye), 34500
      • Faculty of Health Sciences, Istanbul University - Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, 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.

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 inflammatory disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Exercise-Only Group; Participants in this group received a standardized exercise protocol. The program consisted of an evidence-based combination of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights, according to individual tolerance, and progressed by 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next band level. The supervised exercise program was conducted for 6 weeks, 2 days per week. After the 6-week supervised treatment period, participants continued a 6-week home exercise program. Participants were assessed at baseline, week 6, and week 12.
Active Comparator: 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.	Other: Exercise + Forearm Counterforce Brace Group; Participants in this group received a standardized exercise protocol and a counterforce forearm brace in addition to exercise therapy. The program consisted of an evidence-based combination of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights, according to individual tolerance, and progressed by 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next band level. The supervised exercise program was conducted for 6 weeks, 2 days per week. After the 6-week supervised treatment period, participants continued a 6-week home exercise program. The counterforce forearm brace was positioned approximately 2.5 cm distal to the lateral epicondyle and was worn during daytime waking hours for 6 weeks. Participants were instructed to remove the brace during sleep and supervised exercise sessions. Participants were assessed at baseline, week 6, and week 12.
Active Comparator: 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.	Other: Exercise + Wrist Orthosis Group; Participants in this group received a standardized exercise protocol and a wrist orthosis in addition to exercise therapy. The program consisted of an evidence-based combination of wrist isometric, concentric, and eccentric exercises. Free-weight exercises were initiated with 0.5-1 kg weights, according to individual tolerance, and progressed by 0.5-1 kg increments. For exercises using resistance bands, resistance was progressed by advancing to the next band level. The supervised exercise program was conducted for 6 weeks, 2 days per week. After the 6-week supervised treatment period, participants continued a 6-week home exercise program. The wrist orthosis maintained the wrist in slight extension and was worn during daytime waking hours for 6 weeks. Participants were instructed to remove the orthosis during sleep and supervised exercise sessions. Participants were assessed at baseline, week 6, and week 12.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)	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.	Baseline, week 6, week 12; primary endpoint = week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Pain Intensity (Numeric Pain Rating Scale [NPRS])	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 at rest during the previous 24 hours 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.	Baseline, week 6, week 12
Activity Pain Intensity (Numeric Pain Rating Scale [NPRS])	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 during activity 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.	Baseline, week 6, week 12
Pain-Free Grip Strength	Pain-free grip strength is a measure of grip force that can be exerted without provoking pain. It was assessed using a digital hand dynamometer. Participants were instructed to gradually increase their grip force until they first experienced pain, and the grip force at that point was recorded. An increase in pain-free grip strength indicates an improvement in grip performance and pain tolerance.	Baseline, week 6, week 12
Maximum Grip Strength	Maximum grip strength is a measure of the maximum force that can be generated during a grip. It was assessed using a digital hand dynamometer. Participants were instructed to squeeze the dynamometer as strongly as possible, and the maximum grip force was recorded. An increase in maximum grip strength indicates an improvement in grip performance.	Baseline, week 6, week 12
Global Rating of Change (GRC)	The Global Rating of Change (GRC) scale is a subjective measure used to assess patients' perceived change in their condition following treatment. Participants compare their current condition with their condition before treatment and rate their perceived change. In this study, the GRC was used to assess patients' perceived recovery at weeks 6 and 12. For analysis, responses were categorized as unchanged, better, or much better.	Week 6, week 12

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Investigators: Principal Investigator: Büşra Kültür, MSc, Istanbul University - Cerrahpasa; Study Director: Derya Çelik, Prof. Dr., Istanbul University - Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Pain; Tendinopathy; Exercise Therapy; Orthotic Devices
• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Tendinopathy; Tennis Elbow; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: IstanbulUC-FTR-B-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No