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Completed

NCT Number: NCT06735092

Exercise Therapy and Orthoses in Lateral Elbow Tendinopathy: Comparative Effects

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.

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences, Istanbul University - Cerrahpasa

Istanbul, Buyukcekmece, 34500, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise-Only Group

Other

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.

Exercise + Forearm Counterforce Brace Group

Other

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.

Exercise + Wrist Orthosis Group

Other

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.

Primary outcomes

  1. Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)

    Time frame: 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.

Secondary outcomes

  1. Resting Pain Intensity (Numeric Pain Rating Scale [NPRS])

    Time frame: Baseline, week 6, week 12

    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.

  2. Activity Pain Intensity (Numeric Pain Rating Scale [NPRS])

    Time frame: Baseline, week 6, week 12

    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.

  3. Pain-Free Grip Strength

    Time frame: Baseline, week 6, week 12

    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.

  4. Maximum Grip Strength

    Time frame: Baseline, week 6, week 12

    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.

  5. Global Rating of Change (GRC)

    Time frame: Week 6, week 12

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2024
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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