- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07243327
ESWT vs Conventional Physical Therapy in Greater Trochanteric Pain Syndrome
A Prospective Randomized Controlled Trial Comparing the Effectiveness of Extracorporeal Shockwave Therapy and Conventional Physical Therapy in Patients With Greater Trochanteric Pain Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Greater Trochanteric Pain Syndrome (GTPS) is a frequent cause of lateral hip pain and is now understood to be primarily associated with gluteus medius and minimus tendinopathy rather than inflammation of the trochanteric bursa. Although several conservative treatments are available, including nonsteroidal anti-inflammatory drugs and physical therapy modalities, there is no consensus on the most effective treatment strategy. Extracorporeal Shockwave Therapy (ESWT) has emerged as a potential non-invasive treatment option that may promote tissue regeneration, reduce pain, and improve tendon healing.
This prospective randomized controlled trial will include 60 patients aged 18-65 years with MRI-confirmed GTPS. Participants will be randomly assigned (1:1) to either the ESWT group or the conventional physical therapy group. The ESWT group will receive five sessions over 3 weeks (15 Hz, 3 bar, 2000 pulses). The physical therapy group will receive 10 sessions of TENS (20 minutes), hot pack (20 minutes), and continuous ultrasound (1.5 W/cm², 5 minutes). Both groups will be given a standardized exercise program.
Outcome measures include the Visual Analog Scale (VAS) for pain (night, rest, activity), Harris Hip Score, Lower Extremity Functional Scale (LEFS), and the Global Rating of Change Scale. Assessments will be performed at baseline, week 3, and week 12. The primary objective is to compare the effect of ESWT versus conventional physical therapy on pain reduction. Secondary objectives include evaluating functional improvements and global patient satisfaction.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zeynep Karakuzu Güngör, M.D
- Phone Number: +90 507 775 03 75
- Email: zeynepkarakuzu@hotmail.com.tr
Study Locations
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Istanbul, Turkey (Türkiye), 34303
- Recruiting
- Kanuni Sultan Suleyman Training and Research Hospital
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Contact:
- Zeynep Karakuzu Güngör
- Phone Number: +905077750375
- Email: zeynepkarakuzu@hotmail.com.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 65 years
- Lateral hip pain for at least 3 months
- Ability to understand study procedures and provide informed consent
Exclusion Criteria:
- Hip deformities
- Gluteus medius, gluteus minimus, or piriformis tendon tears
- Lumbar radiculopathy or history of lumbar spine surgery
- Recent trauma or active infection in the hip region
- Corticosteroid injection to the hip within the last 6 months
- Neurological, psychiatric, or rheumatologic diseases
- Active malignancy or systemic inflammatory disease
- Cognitive impairment preventing cooperation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ESWT Group
Extracorporeal shockwave therapy applied 5 sessions over 3 weeks (15 Hz, 3 bar, 2000 pulses).
Standard hip exercises included.
|
ESWT applied with Elmed Vibrolith Ortho device at 15 Hz, 3 bar, 2000 pulses, 5 sessions over 3 weeks.
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Active Comparator: Conventional Physical Therapy Group
10 sessions of TENS (20 min), hot pack (20 min), and continuous ultrasound (1.5 W/cm², 5 min).
Standard hip exercises included.
|
10 sessions of TENS (20 min), hot pack (20 min), and continuous ultrasound (1.5 W/cm², 5 min).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Pain Score
Time Frame: Baseline, Week 3, and Week 12
|
Pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS) for activity, rest, and night pain.
The primary endpoint is the change in VAS score from baseline to Week 12.
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Baseline, Week 3, and Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Harris Hip Score
Time Frame: Baseline, Week 3, and Week 12
|
Hip function will be evaluated using the Harris Hip Score, which includes pain, daily activities, gait, and range of motion parameters.
Higher scores indicate better hip function.
|
Baseline, Week 3, and Week 12
|
|
Lower Extremity Functional Scale (LEFS)
Time Frame: Baseline, Week 3, and Week 12
|
The LEFS questionnaire will be used to assess lower limb function.
It consists of 20 items scored from 0 to 4 (total score 0-80), with higher scores indicating better function.
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Baseline, Week 3, and Week 12
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Global Rating of Change (GROC)
Time Frame: Week 3 and Week 12
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Overall patient-perceived improvement will be assessed using the Global Rating of Change Scale, scored from -1 (worse) to +3 (near normal improvement).
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Week 3 and Week 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zeynep Karakuzu Güngör, Kanuni Sultan Suleyman Training and Research Hospital
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Therapeutics
- Physical Therapy Modalities
- Physical Phenomena
- Rehabilitation
- Anesthesia and Analgesia
- Ultrasonic Therapy
- Diathermy
- Hyperthermia, Induced
- Radiation
- Radiation, Nonionizing
- Electric Stimulation Therapy
- Analgesia
- Ultrasonic Waves
- Sound
- Extracorporeal Shockwave Therapy
- Transcutaneous Electric Nerve Stimulation
- High-Energy Shock Waves
Other Study ID Numbers
- BTAS-ESWT-2025-01
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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