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

Foundation IRCCS San Matteo Hospital

Status: Completed

Conditions: Tendinopathy

Treatments: Procedure: focused shock wave therapy; Procedure: ultrasound therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03142971

20130001077

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Intervention:f-ESWT (focused shock wave therapy)

Experimental group

Description:

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.

Treatment:

Procedure: focused shock wave therapy

Intervention:UST (ultrasound therapy)

Active Comparator group

Description:

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.

Treatment:

Procedure: ultrasound therapy