Exercise Therapy and Orthoses in Lateral Elbow Tendinopathy: Comparative Effects

NCT06735092 | Recruiting

• 1 other identifier: IstanbulUC-FTR-B-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis

Keywords

Exercise Therapy; Rehabilitation; Orthotic Devices; Pain; Tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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.

  six weeks

Secondary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

  six weeks

Study Arms (3)

Exercise-Only Group (Control Group)

ACTIVE COMPARATOR

This is the control group, where the patients will only participate in an exercise program, without any additional support or devices like braces. This group helps assess the effectiveness of exercise alone compared to other interventions involving braces. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises will be applied to the individuals in the group.

Other: Exercise-Only Group (Control Group)

Exercise + Forearm Counterforce Brace Group

ACTIVE COMPARATOR

This group will focus on 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 will be applied to the individuals in the group.

Other: Exercise + Forearm Counterforce Brace Group

Exercise + Wrist Brace Group

ACTIVE COMPARATOR

This group will focus on a treatment combining exercise therapy with the use of a wrist brace. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises will be applied to the individuals in the group.

Other: Exercise + Wrist Brace Group

Interventions

Exercise-Only Group (Control Group) OTHER

Participants in this group will only undergo a standardized exercise protocol. The exercises will be part of a program lasting 6 weeks, conducted 2 days per week. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises will be applied to the individuals in the group. For free-weight exercises, participants will start with weights of 0.5-1 kg, tailored to the individual. Progression will be achieved with 0.5-1 kg increments. For exercises using resistance bands, the increase in resistance will be provided by selecting the next level band color. Participants will be assessed before treatment, at the end of the 6th week, and at the end of the 12th week.

Exercise-Only Group (Control Group)

Exercise + Forearm Counterforce Brace Group OTHER

Participants in this group will undergo a standardized exercise protocol and will be provided with a counterforce forearm brace in addition to exercise therapy. The exercises will be part of a program lasting 6 weeks, conducted 2 days per week. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises will be applied to the individuals in the group. For free-weight exercises, participants will start with weights of 0.5-1 kg, tailored to the individual. Progression will be achieved with 0.5-1 kg increments. For exercises using resistance bands, the increase in resistance will be provided by selecting the next level band color. Participants will be assessed before treatment, at the end of the 6th week, and at the end of the 12th week.

Exercise + Forearm Counterforce Brace Group

Exercise + Wrist Brace Group OTHER

Participants in this group will undergo a standardized exercise protocol and will be provided with a wrist brace in addition to exercise therapy. The exercises will be part of a program lasting 6 weeks, conducted 2 days per week. A combined evidence-based exercise program consisting of wrist isometric, concentric, and eccentric exercises will be applied to the individuals in the group. For free-weight exercises, participants will start with weights of 0.5-1 kg, tailored to the individual. Progression will be achieved with 0.5-1 kg increments. For exercises using resistance bands, the increase in resistance will be provided by selecting the next level band color. Participants will be assessed before treatment, at the end of the 6th week, and at the end of the 12th week.

Exercise + Wrist Brace Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Faculty of Health Sciences, Istanbul University - Cerrahpasa

Istanbul, Buyukcekmece, 34500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tennis Elbow; Pain; Tendinopathy

Interventions

Control Groups; Exercise

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Büşra Kültür, MSc

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Derya Çelik, Prof. Dr.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Büşra Kültür, MSc (c)

CONTACT

+905352928772; busragguler@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants in the study are blind to the group distribution and do not know the reason for their assignment to specific groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student

Model Details: This study involves three groups with exercise therapy: one with exercise only, one with exercise in addition to an elbow orthosis, and one with exercise in addition to a wrist orthosis.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: December 2, 2024
• Primary Completion: August 15, 2025
• Study Completion: October 15, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)