Shock Wave Therapy Plus Exercise in GTPS

Greater Trochanteric Pain Syndrome of Both Lower Limbs Clinical Trial

— GTPSSWEX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06248905
• Other study ID #: 0005201/24
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: January 2024
• Source: Foundation IRCCS San Matteo Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: February 1, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bursitis
• Greater Trochanteric Pain Syndrome of Both Lower Limbs
• Syndrome

Intervention

Other:
• Rehabilitation program based on the strengthening of gluteal muscles
Physiotherapy program (8 weeks)
• Extracorporeal shock wave therapy
Focused shock wave therapy (3 weeks)

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Foundation IRCCS San Matteo Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS Pain	Change in lateral hip pain measured by the Numeric Rating Scale (NRS)	6 months
Secondary	EQ5D Quality of life	Change in quality of life measured by EQ-5D-3L	12 months
Secondary	VISA-G Disability	Change in disability measured by VISA-G questionnaire	12 months
Secondary	Functional capacity (strength of gluteal muscles)	Change in functional capacity measured by MRC scale	12 months