Shock Wave Therapy for Lateral Hip Pain, Caused by Tendon Pathology

Tendinopathy Clinical Trial

Official title:

Focused Extracorporeal Shock Wave Therapy for Greater Trochanteric Pain Syndrome With Gluteal Tendinopathy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142971
• Other study ID #: 20130001077
• Status: Completed
• Phase: N/A
• First received: April 28, 2017
• Last updated: May 9, 2017
• Start date: March 2013
• Est. completion date: May 4, 2016

Study information

• Verified date: May 2017
• 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 focal shock wave is an effective treatment, with respect to hip pain and lower limb function, in a population affected by greater trochanteric pain syndrome with gluteal tendinopathy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 4, 2016
• Est. primary completion date: May 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• duration of lateral hip pain of six weeks or longer,

• normal passive hip range of movement (ROM),

• sonographic evidence of gluteal tendinopathy at their insertional site at the greater trochanter

Exclusion Criteria:

• general contraindication to extracorporeal shock wave therapy (pacemaker, pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area),

• history of rheumatologic disease,

• previous fractures or surgery in the affected limb,

• full thickness tear of the gluteal tendons,

• osteoarthritis of the hip (with ROM limitation),

• clinical signs of lumbar radiculopathy,

• corticosteroid injections or other conservative therapies (except pharmacological pain treatments) since the onset of the current pain episode.

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Procedure:
• focused shock wave therapy

• ultrasound therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Foundation IRCCS San Matteo Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	p-NRS	Change from baseline p-NRS (pain-on-movement numeric rating scale) at 2 months and at 6 months.	Baseline, at two months, at six months
Primary	LEFS score	Change from baseline LEFS (Lower extremity functional scale) total score at 2 months and at 6 months	Baseline, at two months, at six months