- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07238413
Effect of Scapular Stabilization Exercises and ESWT in Patients With Lateral Epicondylitis
Investigation of the Effect of Scapular Stabilization Exercises Applied in Addition to Extracorporeal Shock Wave Therapy on Pain, Muscle Strength, Functional Status, and Quality of Life in Patients With Lateral Epicondylitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Forty eight volunteer participants with lateral epycondilitis aged 18 to 65 years were included in the study. Participants were randomly divided into two groups as study and control group. In the control group, a protocol including ESWT, stretching of the ECRB muscle and wrist extensor muscles, and isometric, eccentric, and concentric strengthening exercises for the wrist extensors will be applied.
In the study group, the same protocol will be administered (ESWT, stretching of the ECRB and wrist extensor muscles, and strengthening exercises), with the addition of scapular stabilization exercises.
The exercise program will be conducted twice a week for 8 weeks. At the beginning of the treatment and at the end of the eighth week, pain, muscle strength, functional status, and Quality of Life were evaluated between groups
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: büşra yalçın, MSc
- Phone Number: +905075157949
- Email: busracakmakyalcin@gmail.com
Study Locations
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Istanbul, Turkey (Türkiye)
- Recruiting
- Büşra Yalçın
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Contact:
- büsra yalçın Student, MSc
- Phone Number: +90 507 515 79 49
- Email: busracakmakyalcin@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Aged between 18 and 65 years.
- Diagnosed with lateral epicondylitis by a physician, with positive Mill's, Cozen's, or Thomsen tests.
- Experiencing pain and tenderness over and around the lateral epicondyle for at least 3 months, with symptoms exacerbated by resisted elbow extension, wrist extension, gripping, and supination.
- Willing to voluntarily participate in the study.
Exclusion Criteria:
• Individuals with serious systemic or cardiovascular diseases that contraindicate exercise of the hand and upper extremity.
- Those diagnosed with upper extremity entrapment neuropathies.
- Patients with a diagnosis of malignancy.
- Individuals with open wounds on the hand or upper extremity.
- Pregnant women or those suspected of being pregnant.
- Patients who have received physiotherapy and/or injection treatments within the last 6 weeks.
- Patients with diabetes mellitus, rheumatologic diseases, or neurological disorders.
- Individuals who have undergone upper extremity surgery or had an upper extremity fracture within the last 6 months.
- Patients with coagulation disorders or those receiving anticoagulant therapy.
- Individuals with conditions causing degenerative changes in the hand and upper extremity.
- Patients diagnosed with carpal tunnel syndrome, cubital tunnel syndrome, thoracic outlet syndrome, medial epicondylitis, radiohumeral bursitis, or cervical disc pathology.
- Patients using analgesic or anti-inflammatory medications other than acetaminophen (paracetamol).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
Participants in the control group will receive a protocol consisting of extracorporeal shock wave therapy (ESWT), stretching exercises for the extensor carpi radialis brevis (ECRB) muscle and wrist extensor muscles, as well as isometric, eccentric, and concentric strengthening exercises targeting the wrist extensors. The ESWT will be applied once a week, for a total of 5 sessions |
Participants in the study group will follow a treatment protocol consisting of extracorporeal shock wave therapy (ESWT) - 5 sessions, once per week - combined with stretching exercises for the extensor carpi radialis brevis (ECRB) and wrist extensor muscles, strengthening exercises for the wrist extensors, and an additional scapular stabilization exercise program. This combined program will be performed twice per week for a duration of 8 weeks. The scapular stabilization component will include strengthening exercises targeting the lower and middle trapezius and serratus anterior muscles. The program will consist of scapular clock exercises, wall push-up exercises, and wall slide or ball slide exercises performed on a wall. |
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Experimental: Study group
Participants in the study group will follow a treatment protocol consisting of extracorporeal shock wave therapy (ESWT) - 5 sessions, once per week - combined with stretching exercises for the extensor carpi radialis brevis (ECRB) and wrist extensor muscles, strengthening exercises for the wrist extensors, and an additional scapular stabilization exercise program. This combined program will be performed twice per week for a duration of 8 weeks. The scapular stabilization component will include strengthening exercises targeting the lower and middle trapezius and serratus anterior muscles. The program will consist of scapular clock exercises, wall push-up exercises, and wall slide or ball slide exercises performed on a wall. |
Participants in the study group will follow a treatment protocol consisting of extracorporeal shock wave therapy (ESWT) - 5 sessions, once per week - combined with stretching exercises for the extensor carpi radialis brevis (ECRB) and wrist extensor muscles, strengthening exercises for the wrist extensors, and an additional scapular stabilization exercise program. This combined program will be performed twice per week for a duration of 8 weeks. The scapular stabilization component will include strengthening exercises targeting the lower and middle trapezius and serratus anterior muscles. The program will consist of scapular clock exercises, wall push-up exercises, and wall slide or ball slide exercises performed on a wall. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Assessment: Visual Analog Scale (VAS)
Time Frame: From baseline assesment to the end of treatment at 8 weeks
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Pain will be assessed using the Visual Analog Scale (VAS).
On this scale, a score of 0 indicates "no pain" and a score of 10 represents "the worst possible pain."
Participants will be asked to mark their perceived pain level on a 10 cm horizontal line, anchored at 0 and 10.
The distance from the left end of the line to the participant's mark will be measured in centimeters and recorded.
The VAS is a valid and reliable tool for pain assessment.
Pain will be evaluated separately at rest, during activity, and at night.
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From baseline assesment to the end of treatment at 8 weeks
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Scapular Position Assessment: (Lateral Scapular Slide Test)
Time Frame: From enrollment to the end of treatment at 8 weeks
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The distance between the inferior angle of each scapula and the nearest spinous process will be measured in three different test positions on both sides using a measuring tape. A side-to-side difference of 1.5 cm or more is considered a positive result and indicates scapular asymmetry. |
From enrollment to the end of treatment at 8 weeks
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Pressure Pain Threshold Measurement
Time Frame: From enrollment to the end of treatment at 8 weeks
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Measurements will be performed with a digital algometer while the participant is seated, with the shoulder abducted at 30°, the elbow flexed at 90°, and the forearm, wrist, and hand supported.
Pressure pain threshold will be measured over the lateral epicondyle.
Three measurements will be taken at each point using the 1 cm² tip of the algometer, and the average of these three measurements will be recorded.
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From enrollment to the end of treatment at 8 weeks
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Grip Strength
Time Frame: From enrollment to the end of treatment at 8 weeks
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Patients' grip strength will be assessed using a Jamar hand dynamometer, following the protocol recommended by the American Society of Hand Therapists.
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From enrollment to the end of treatment at 8 weeks
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Muscle Strength
Time Frame: 0 and 8 week
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Muscle strength of the lower and middle trapezius, serratus anterior, and wrist extensor muscles will be measured using a handheld dynamometer before and after the treatment.
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0 and 8 week
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Functional Status
Time Frame: From enrollment to the end of treatment at 8 weeks
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PRTEE (Patient-Rated Tennis Elbow Evaluation): The PRTEE is designed specifically for lateral epicondylitis and consists of 15 items divided into 3 subscales. Each item is scored from 0 to 10. Higher scores on the scale indicate worse functional status. (The subscales assess pain, specific activities, and general daily activities.) JHand: JHand evaluates the functional status of the upper extremity and consists of 25 items. Each item is scored on a scale from 0 (no difficulty) to 4 (unable to perform). Higher scores on this scale also indicate worse functional status. |
From enrollment to the end of treatment at 8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Health-Related Quality of Life
Time Frame: baseline and at the end of the 8-week intervention period.
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Short Form-12 Health Survey (SF-12) is a validated and reliable questionnaire used to assess health-related quality of life.
It includes 12 items covering both physical and mental health domains, and provides two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Higher scores indicate better perceived health status.
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baseline and at the end of the 8-week intervention period.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TR ISTANBU60
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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