Clinical Effectiveness of Extracorporeal Shock Wave Therapy Combined With Exercise in Patients With Lateral Epicondylitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Extracorporeal Shock Wave Therapy (ESWT) applied in addition to exercise does not create a significant difference in pain level, grip strength and functional status in individuals with lateral epicondylitis compared to exercise alone.
Study Overview
Brief Summary
The primary objective of this study is to compare the clinical effectiveness of exercise therapy alone versus exercise combined with Extracorporeal Shock Wave Therapy (ESWT) in individuals with lateral epicondylitis, focusing on changes in pain, grip strength, functional status, and overall treatment success.
Detailed Description
This randomized, controlled, prospective clinical trial aims to compare the effectiveness of exercise therapy alone versus exercise therapy combined with Extracorporeal Shock Wave Therapy (ESWT) in individuals diagnosed with lateral epicondylitis. The study is conducted at a single center and includes adult participants who meet predefined eligibility criteria.
Participants are randomly assigned to one of two groups: an exercise-only group and an exercise-plus-ESWT group. Both groups follow a 4-week treatment program consisting of 12 sessions delivered three times per week. The exercise program includes isometric, isotonic, and stretching exercises targeting wrist extensors and related musculature. These exercises are demonstrated and supervised by physiotherapists, with participants encouraged to continue them as a home program.
In the intervention group, ESWT is administered once weekly for a total of four sessions. A radial-type ESWT device is used with preset parameters (2.0 bar pressure, 10 Hz frequency, 2000 pulses per session). All ESWT applications are performed by trained physiotherapists.
Clinical assessments occur at baseline and at the end of the 4-week intervention. Pain intensity, upper-extremity functional capacity, and condition-specific functional limitations are measured using validated outcome tools. Global improvement is also recorded at post-treatment to evaluate the participant's perceived benefit.
This study is designed to provide comparative data on the added value of ESWT when combined with a structured exercise program for the management of lateral epicondylitis, with the goal of informing clinical decision-making and optimizing treatment strategies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals with the following characteristics will be included in the study:
- •Being 18 years of age or older
- •Having a clinical diagnosis of lateral epicondylitis
- •Not having received any other similar treatment within the last 6 months
- •Having the cognitive ability to understand the Turkish questionnaire and assessment forms
- •Voluntarily agreeing to participate in the study and providing written informed consent
Exclusion Criteria
- •Individuals with one or more of the following conditions will be excluded from the study:
- •Having a history of concomitant systemic, rheumatological, or inflammatory diseases that could affect pain
- •Having a history of trauma, surgery, or neurological disease in the upper extremity
- •Presence of conditions other than lateral epicondylitis, such as tendinopathy, bursitis, or nerve entrapment
- •Having major psychiatric disorders that could affect the pain threshold (e.g., major depression, schizophrenia)
Outcomes
Primary Outcomes
Extracorporeal Shock Wave Therapy (ESWT) applied in addition to exercise does not create a significant difference in pain level, grip strength and functional status in individuals with lateral epicondylitis compared to exercise alone.
Time Frame: 8 week
Pain Intensity (Visual Analog Scale - VAS) Description: Pain intensity will be assessed using the Visual Analog Scale, a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will mark their perceived pain level on the line. Time Frame: Baseline and 8 weeks Outcome Type: Continuous Interpretation: Higher scores indicate worse pain.
Upper Extremity Function (Quick Disabilities of the Arm, Shoulder and Hand Questionnaire - QuickDASH)
Time Frame: 8 week
Upper Extremity Function (Quick Disabilities of the Arm, Shoulder and Hand Questionnaire - QuickDASH) Description: Functional status will be measured using the QuickDASH questionnaire. Scores range from 0 (no disability) to 100 (severe disability). Time Frame: Baseline and 8 weeks Outcome Type: Continuous Interpretation: Higher scores indicate worse functional impairment.
Secondary Outcomes
No secondary outcomes reported
Investigators
salih tan
Doctorate
Istanbul Medipol University Hospital