Radial Extracorporeal Shock Wave Therapy Versus Platelet-rich Plasma Injection for Greater Trochanteric Pain Syndrome

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04537091
Collaborator
(none)
30
1
2
5.2
5.8

Study Details

Study Description

Brief Summary

Greater trochanteric pain syndrome (GTPS), is characterised by pain around the greater trochanter. Failure of first-line management for GTPS is followed by second-line treatments range from extracorporeal shock wave therapy (ESWT), corticosteroid or platelet-rich plasma (PRP) injections, and surgery. In a systematic reviews, PRP seems a viable effective and safe alternative option for GTPS after failed physical therapy. Also, positive results from previous systematic reviews involving radial ESWT (rESWT) as a treatment for GTPS.

In the literature review, there is no comparison of the effectiveness of ESWT and PRP injection in patients with GTPS. The aim of this study was to investigate the effects of rESWT and PRP injection on pain, hip disability, and quality of life in patients with GTPS

Condition or Disease Intervention/Treatment Phase
  • Procedure: rESWT
  • Procedure: PRP injection
N/A

Detailed Description

The pain and activities of daily living, referring to the previous week, and assessments of hip function (limping) and range of motion were evaluted by Harris Hip Score (HHS). The pain severity during rest and activity in the previous week was evaluted by Visual Analog Scale (VAS). The pain and activity limitation was evaluted by The Roles and maudsley (RM). The quality of life was evaluted by The EQ-5D-3L scale.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Radial Extracorporeal Shock Wave Therapy Versus Platelet-rich Plasma Injection for the Treatment of Greater Trochanteric Pain Syndrome With Gluteal Tendinopathy: a Randomized Controlled Trial
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Jan 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: ESWT group: rESWT

rESWT treatment was applied to patients

Procedure: rESWT
rESWT was administered once per week for 3 weeks with 4 bar pneumatic pressure, 10 Hz frequency, with 2000 pulses. Radial shock waves were transmitted to the greater trochanteric region with the maximum pain/tenderness that was identified with patients' reaction with small circular movements with an adequate amount of contact gel

Experimental: PRP group: PRP injection

PRP treatment was applied to patients

Procedure: PRP injection
PRP injection is performed with a high resolution 7-12-megahertz linear probe ultrasonography device. 15 ml of blood will be drawn from the patients and the blood will be centrifuged for 5 minutes. 4-5 ml PRP will be injected into the affected gluteal tendons accompanied by ultrasonography.

Outcome Measures

Primary Outcome Measures

  1. Harris Hip Score (HHS) [Changes from baseline in Harris Hip Score to 1 month and 6 months.]

    The index consists of questions about pain and activities of daily living, referring to the previous week, and assessments of hip function (limping) and range of motion. Score ranges from 100 (no disability) to 0 (maximum disability).

Secondary Outcome Measures

  1. Visual Analog Scale (VAS) [Changes from baseline in Visual Analog Scale score to 1 month and 6 months.]

    The self-evaluation of pain severity during rest and activity in the previous week was calculated using a 10-cm VAS scale, where 0 in the left corner of the scale represented 'no pain' and 10 in the right corner represented 'the worst pain that could be imagined'

  2. The Roles and maudsley (RM) [Changes from baseline in Roles and maudsley score to 1 month and 6 months.]

    RM score was used to evaluate pain and activity limitation as classified in four categories: 1 point = excellent, 2 points = good, 3 points = fair, and 4 points = poor.

  3. EuroQol five-dimensional questionnaire (EQ-5D-3L) [Changes from baseline in EuroQol five-dimensional questionnaire score to 1 month and 6 months.]

    The EQ-5D-3L scale, which scores five health conditions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) through evaluation at 3 levels (no problems, some problems, or extreme problems), was used to evaluate the quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18 years old

  • Complaining of pain located anterior, lateral or posterior to the great trochanter for more than 3 months

  • Pain while lying on the affected side

  • Local tenderness on palpation of the area of the great trochanter

  • MRI evidence of gluteus minimus or medius tendinopathy

  • Refractory to conservative management

Exclusion Criteria:
  • Presence of signs and symptoms of another cause of regional hip pain.

  • Full-thickness tear of the involved gluteal tendons, bursa, and intra-articular structures

  • Evidence of concomitant injury to the involved lower extremity, including radiculopathy or radiculitis, ischial tuberosity avulsion

  • Severe knee or hip osteoarthritis

  • Previous hip surgery or use of ESWT for GTPS.

  • Acute low back pain

  • Implanted pacemaker

  • Vascular, neurologic, rheumatic diseases.

  • Any neoplastic disorders

  • Blood coagulation disorders or use of antiplatelet or anticoagulant drugs

  • Pregnancy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Physical Medicine and Rehabilitation Training and Research Hospital Istanbul Bahcelievler Turkey 34180

Sponsors and Collaborators

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Study Chair: Mustafa Corum, MD, Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mustafa Corum, Principal Investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04537091
Other Study ID Numbers:
  • 2020-309
First Posted:
Sep 3, 2020
Last Update Posted:
Feb 10, 2021
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2021