Clinical trial NCT06735092: Exercise Therapy and Orthoses in Lateral Elbow Tendinopathy: Comparative Effects
Official title: Investigation of the Effects of Different Types of Orthoses Used in Addition to Exercise Therapy in Lateral Elbow Tendinopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Exercise Therapy
Rehabilitation
Orthotic Devices
Pain
Tendinopathy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
timeFrame: six weeks
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: six weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Faculty of Health Sciences, Istanbul University - Cerrahpasa
state: Buyukcekmece
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Büşra Kültür, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Derya Çelik, Prof. Dr.
role: STUDY_DIRECTOR
References: