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

Primary Purpose

Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
focused shock wave therapy
ultrasound therapy
Sponsored by
Foundation IRCCS San Matteo Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Shock waves, Greater trochanteric pain syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention:f-ESWT (focused shock wave therapy)

    Intervention:UST (ultrasound therapy)

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    p-NRS
    Change from baseline p-NRS (pain-on-movement numeric rating scale) at 2 months and at 6 months.
    LEFS score
    Change from baseline LEFS (Lower extremity functional scale) total score at 2 months and at 6 months

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2017
    Last Updated
    May 9, 2017
    Sponsor
    Foundation IRCCS San Matteo Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03142971
    Brief Title
    Shock Wave Therapy for Lateral Hip Pain, Caused by Tendon Pathology
    Official Title
    Focused Extracorporeal Shock Wave Therapy for Greater Trochanteric Pain Syndrome With Gluteal Tendinopathy: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (Actual)
    Primary Completion Date
    May 4, 2016 (Actual)
    Study Completion Date
    May 4, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Foundation IRCCS San Matteo Hospital

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tendinopathy
    Keywords
    Shock waves, Greater trochanteric pain syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention:f-ESWT (focused shock wave therapy)
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Intervention:UST (ultrasound therapy)
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    focused shock wave therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    ultrasound therapy
    Primary Outcome Measure Information:
    Title
    p-NRS
    Description
    Change from baseline p-NRS (pain-on-movement numeric rating scale) at 2 months and at 6 months.
    Time Frame
    Baseline, at two months, at six months
    Title
    LEFS score
    Description
    Change from baseline LEFS (Lower extremity functional scale) total score at 2 months and at 6 months
    Time Frame
    Baseline, at two months, at six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

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

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