NCT07243327

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

November 14, 2025

Last Update Submit

January 24, 2026

Conditions

Keywords

Extracorporeal shockwave therapyPhysical therapyHip painESWT

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Analog Scale (VAS) Pain Score

    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.

    Baseline, Week 3, and Week 12

Secondary Outcomes (3)

  • Harris Hip Score

    Baseline, Week 3, and Week 12

  • Lower Extremity Functional Scale (LEFS)

    Baseline, Week 3, and Week 12

  • Global Rating of Change (GROC)

    Week 3 and Week 12

Study Arms (2)

ESWT Group

EXPERIMENTAL

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

Device: Extracorporeal Shockwave Therapy (ESWT)

Conventional Physical Therapy Group

ACTIVE COMPARATOR

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

Other: TENS; Hot Pack; Ultrasound

Interventions

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

ESWT Group

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

Conventional Physical Therapy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years
  • Lateral hip pain for at least 3 months
  • Ability to understand study procedures and provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Extracorporeal Shockwave TherapyTranscutaneous Electric Nerve StimulationHigh-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationElectric Stimulation TherapyAnalgesiaAnesthesia and AnalgesiaUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Zeynep Karakuzu Güngör

    Kanuni Sultan Suleyman Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep Karakuzu Güngör, M.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm, parallel-group, randomized controlled trial (1:1 allocation).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kanuni Sultan Suleyman Training and Research Hospital

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 21, 2025

Study Start

December 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations