Shock Wave Therapy Plus Exercise in GTPS

Not Applicable

Active, not recruiting

• Conditions: Greater Trochanteric Pain Syndrome of Both Lower Limbs
• Interventions: Other: Extracorporeal shock wave therapy; Other: Rehabilitation program based on the strengthening of gluteal muscles

• Registration Number: NCT06248905
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

The aim of this randomized controlled study is to investigate if the sequential administration of focused shock wave therapy and of a rehabilitation program based on the strengthening of gluteal muscles is more effective than a standard shock wave treatment for greater trochanteric pain syndrome

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-26
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08
• Primary Completion: 2026-07-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Unilateral hip pain of four weeks or longer duration
• Pain to palpation in the greater trochanteric area at physical examination
• Pain in hip end-range abduction/rotation/adduction at physical examination
• Gluteal tendinopathy, in absence of full thickness tears at a sonographic examination of the gluteal tendons
• Adult age and written informed consent

Exclusion Criteria

• No hip osteoarthritis, diagnosed according to Altman's criteria
• No history of knee osteoarthritis
• No history of rheumatologic diseases
• No previous fractures or surgery in the affected limb
• No clinical signs of lumbar radiculopathy at physical examination
• No corticosteroid injections, since the onset of the current pain episode
• No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
shockwaves	Extracorporeal shock wave therapy	Enrolled subject will be treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician, using a device powered by an electromagnetic generator. Focusing: (out-of-line) ultrasound-guided with the patient lying in lateral decubitus. Dosimetry: 1500-1800 shots per session with an energy flux density equal to 0.10-0.20 mJ/mm2 (frequency=4Hz).
exercise plus shockwaves	Rehabilitation program based on the strengthening of gluteal muscles	Enrolled subject will be treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician, using a device powered by an electromagnetic generator. Focusing: (out-of-line) ultrasound-guided with the patient lying in lateral decubitus. Dosimetry: 1500-1800 shots per session with an energy flux density equal to 0.10-0.20 mJ/mm2 (frequency=4Hz). The experimental group will then start a physiotherapy program for the following 8 weeks. The program is made up of strengthening and stretching exercises of gluteal muscles, planned to be daily performed at home. Four supervised physiotherapy session will be planned on week 0-1-2-4, during which the exercise loading will be implemented.
exercise plus shockwaves	Extracorporeal shock wave therapy	Enrolled subject will be treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician, using a device powered by an electromagnetic generator. Focusing: (out-of-line) ultrasound-guided with the patient lying in lateral decubitus. Dosimetry: 1500-1800 shots per session with an energy flux density equal to 0.10-0.20 mJ/mm2 (frequency=4Hz). The experimental group will then start a physiotherapy program for the following 8 weeks. The program is made up of strengthening and stretching exercises of gluteal muscles, planned to be daily performed at home. Four supervised physiotherapy session will be planned on week 0-1-2-4, during which the exercise loading will be implemented.

Primary Outcome Measures

Name	Time	Method
NRS Pain	6 months	Change in lateral hip pain measured by the Numeric Rating Scale (NRS)

Secondary Outcome Measures

Name	Time	Method
Functional capacity (strength of gluteal muscles)	12 months	Change in functional capacity measured by MRC scale
EQ5D Quality of life	12 months	Change in quality of life measured by EQ-5D-3L
VISA-G Disability	12 months	Change in disability measured by VISA-G questionnaire

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy