Exercise Therapy and Orthoses in Lateral Elbow Tendinopathy: Comparative Effects

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul University - Cerrahpasa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise-Only Group (Control Group)

    Other intervention

    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 + Forearm Counterforce Brace Group

    Other intervention

    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 + Wrist Brace Group

    Other intervention

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Exercise-Only Group (Control Group)Active comparator 1 intervention
Group B: Exercise + Forearm Counterforce Brace GroupActive comparator 1 intervention
Group C: Exercise + Wrist Brace GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
six weeks

Secondary outcomes

1

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 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.

Time frame
six weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.