Shock Wave Therapy Plus Exercise in GTPS

NCT06248905 | Active Not Recruiting

• 1 other identifier: 0005201/24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Greater Trochanteric Pain Syndrome of Both Lower Limbs

Outcome Measures

Primary Outcomes (1)

• NRS Pain

  Change in lateral hip pain measured by the Numeric Rating Scale (NRS)

  6 months

Secondary Outcomes (3)

• EQ5D Quality of life

  12 months

• VISA-G Disability

  12 months

• Functional capacity (strength of gluteal muscles)

  12 months

Study Arms (2)

exercise plus shockwaves

EXPERIMENTAL

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.

Other: Rehabilitation program based on the strengthening of gluteal muscles; Other: Extracorporeal shock wave therapy

shockwaves

ACTIVE COMPARATOR

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).

Other: Extracorporeal shock wave therapy

Interventions

Rehabilitation program based on the strengthening of gluteal muscles OTHER

Physiotherapy program (8 weeks)

exercise plus shockwaves

Extracorporeal shock wave therapy OTHER

Focused shock wave therapy (3 weeks)

exercise plus shockwaves; shockwaves

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicine Doctor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: January 26, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

IT (1)