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

NCT03142971 | Completed

• 1 other identifier: 20130001077
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

Shock waves; Greater trochanteric pain syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention:f-ESWT (focused shock wave therapy)

EXPERIMENTAL

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

Intervention:UST (ultrasound therapy)

ACTIVE COMPARATOR

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

Interventions

focused shock wave therapy PROCEDURE

Intervention:f-ESWT (focused shock wave therapy)

ultrasound therapy PROCEDURE

Intervention:UST (ultrasound therapy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

MeSH Terms

Conditions

Tendinopathy

Interventions

Extracorporeal Shockwave Therapy; Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 8, 2017
• Study Start: March 1, 2013
• Primary Completion: May 4, 2016
• Study Completion: May 4, 2016
• Last Updated: May 10, 2017

Record last verified: 2017-05