Shock Wave Therapy Plus Exercise in GTPS (GTPSSWEX)

Foundation IRCCS San Matteo Hospital

Status: Active, not recruiting

Conditions: Greater Trochanteric Pain Syndrome of Both Lower Limbs

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06248905

0005201/24

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

exercise plus shockwaves

Experimental group

Description:

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.

Treatment:

Other: Rehabilitation program based on the strengthening of gluteal muscles

Other: Extracorporeal shock wave therapy

shockwaves

Active Comparator group

Description:

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).

Treatment:

Other: Extracorporeal shock wave therapy