Shock Wave Therapy Plus Exercise in GTPS (GTPSSWEX)

Shock Wave Therapy Combined With Strengthening Exercise of Hip Abductor Muscles in the Greater Trochanteric Pain Syndrome: a Randomized Controlled Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Greater Trochanteric Pain Syndrome of Both Lower Limbs
• Intervention / Treatment: Other: Rehabilitation program based on the strengthening of gluteal muscles; Other: Extracorporeal shock wave therapy

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise plus shockwaves; 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; Physiotherapy program (8 weeks); Other: Extracorporeal shock wave therapy; Focused shock wave therapy (3 weeks)
Active Comparator: shockwaves; 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; Focused shock wave therapy (3 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS Pain	Change in lateral hip pain measured by the Numeric Rating Scale (NRS)	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Foundation IRCCS San Matteo Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Bursitis
• Other Study ID Numbers: 0005201/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No