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

Not Applicable

Completed

• Conditions: Tendinopathy
• Interventions: Procedure: focused shock wave therapy; Procedure: ultrasound therapy

• Registration Number: NCT03142971
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2016-05-04
• Study Completion: 2016-05-04
• Study First Submitted: 2017-04-28
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-08
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention:f-ESWT (focused shock wave therapy)	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.
Intervention:UST (ultrasound therapy)	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.

Primary Outcome Measures

Name	Time	Method
LEFS score	Baseline, at two months, at six months	Change from baseline LEFS (Lower extremity functional scale) total score at 2 months and at 6 months
p-NRS	Baseline, at two months, at six months	Change from baseline p-NRS (pain-on-movement numeric rating scale) at 2 months and at 6 months.