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

NCT ID: NCT03142971

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-05-04

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.

Conditions

Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

focused shock wave therapy

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

ultrasound therapy

Intervention Type: PROCEDURE

Interventions

focused shock wave therapy

Intervention Type: PROCEDURE

ultrasound therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Ettore Carlis

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20130001077

Identifier Type: -

Identifier Source: org_study_id