Exercise Therapy and Orthoses in Lateral Elbow Tendinopathy: Comparative Effects

Istanbul University - Cerrahpasa

Status: Enrolling

Conditions: Lateral Epicondylitis

Treatments: Other: Exercise + Wrist Brace Group; Other: Exercise + Forearm Counterforce Brace Group; Other: Exercise-Only Group (Control Group)

Study type: Interventional

Funder types: Other

Identifiers

NCT06735092

IstanbulUC-FTR-B-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Exercise-Only Group (Control Group)

Active Comparator group

Description:

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.

Treatment:

Other: Exercise-Only Group (Control Group)

Exercise + Forearm Counterforce Brace Group

Active Comparator group

Description:

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.

Treatment:

Other: Exercise + Forearm Counterforce Brace Group

Exercise + Wrist Brace Group

Active Comparator group

Description:

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.

Treatment:

Other: Exercise + Wrist Brace Group