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

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

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.

Study Overview

• Status: Completed
• Conditions: Tendinopathy
• Intervention / Treatment: Procedure: focused shock wave therapy; Procedure: ultrasound therapy

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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: Intervention:f-ESWT (focused shock wave therapy); In the study-group, a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf) was used . At the beginning of each treatment session, the enthesis of the gluteal tendons at the greater trochanter (at the anterior half of its lateral facet) was targeted through a non-inline sonographic focusing, using a linear probe (7.5-12 MHz) connected to an ultrasound scanner (ESAOTE MYLAB FIVE, Genova and Florence, Italy). All patients received 1800 pulses (frequency=4Hz) of an energy flux density of 0.15 mJ/mm2 once a week for three consecutive weeks. At the first treatment session, the energy flux density was gradually increased from 0.05 to 0.15 mJ/mm2 during the first 500 pulses.	Procedure: focused shock wave therapy
Active Comparator: Intervention:UST (ultrasound therapy); In the control-group, we used a mono-frequency device (ROLAND, RT-20 series, frequency=1MHz). We treated an area of 5cm2, softly moving the US-probe around the most painful point of the greater trochanter at the clinical palpation. UST was supplied in a continuous modality, with an intensity of 1.5 W/cm2, for ten consecutive daily sessions of ten minutes each.	Procedure: ultrasound therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Foundation IRCCS San Matteo Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): May 4, 2016
• Study Completion (Actual): May 4, 2016

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Shock waves; Greater trochanteric pain syndrome
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: 20130001077

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No