ESWT vs Conventional Physical Therapy in Greater Trochanteric Pain Syndrome

NCT ID: NCT07243327

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-03-31

Brief Summary

This study aims to compare the effectiveness of Extracorporeal Shockwave Therapy (ESWT) with conventional physical therapy in patients with Greater Trochanteric Pain Syndrome (GTPS). GTPS is a common cause of lateral hip pain, often related to gluteal tendinopathy rather than trochanteric bursitis. Sixty patients will be randomly assigned to two groups: ESWT or conventional physical therapy (TENS, hot pack, ultrasound). Pain (VAS), hip function (Harris Hip Score), lower limb function (LEFS), and global improvement will be evaluated at baseline, week 3, and week 12. The purpose of this study is to determine which treatment provides greater pain relief and functional improvement.

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.

Conditions

Greater Trochanteric Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESWT Group

Extracorporeal shockwave therapy applied 5 sessions over 3 weeks (15 Hz, 3 bar, 2000 pulses). Standard hip exercises included.

Group Type: EXPERIMENTAL

Extracorporeal Shockwave Therapy (ESWT)

Intervention Type: DEVICE

ESWT applied with Elmed Vibrolith Ortho device at 15 Hz, 3 bar, 2000 pulses, 5 sessions over 3 weeks.

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.

Group Type: ACTIVE_COMPARATOR

TENS; Hot Pack; Ultrasound

Intervention Type: OTHER

10 sessions of TENS (20 min), hot pack (20 min), and continuous ultrasound (1.5 W/cm², 5 min).

Interventions

Extracorporeal Shockwave Therapy (ESWT)

ESWT applied with Elmed Vibrolith Ortho device at 15 Hz, 3 bar, 2000 pulses, 5 sessions over 3 weeks.

Intervention Type: DEVICE

TENS; Hot Pack; Ultrasound

10 sessions of TENS (20 min), hot pack (20 min), and continuous ultrasound (1.5 W/cm², 5 min).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Karakuzu Güngör

Kanuni Sultan Suleyman Training and Research Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep Karakuzu Güngör

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Suleyman Training and Research Hospital

Central Contacts

Zeynep Karakuzu Güngör, M.D

Role: CONTACT

zeynepkarakuzu@hotmail.com.tr

+90 507 775 03 75

Other Identifiers

BTAS-ESWT-2025-01

Identifier Type: -

Identifier Source: org_study_id