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

Primary Purpose

Gluteal Tendinopathy, Greater Trochanteric Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
rESWT
PRP injection
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gluteal Tendinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ESWT group: rESWT

PRP group: PRP injection

Arm Description

rESWT treatment was applied to patients

PRP treatment was applied to patients

Outcomes

Primary Outcome Measures

Harris Hip Score (HHS)
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

Visual Analog Scale (VAS)
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'
The Roles and maudsley (RM)
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.
EuroQol five-dimensional questionnaire (EQ-5D-3L)
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.

Full Information

First Posted
August 21, 2020
Last Updated
February 9, 2021
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04537091
Brief Title
Radial Extracorporeal Shock Wave Therapy Versus Platelet-rich Plasma Injection for Greater Trochanteric Pain Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
January 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gluteal Tendinopathy, Greater Trochanteric Pain Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESWT group: rESWT
Arm Type
Experimental
Arm Description
rESWT treatment was applied to patients
Arm Title
PRP group: PRP injection
Arm Type
Experimental
Arm Description
PRP treatment was applied to patients
Intervention Type
Procedure
Intervention Name(s)
rESWT
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
PRP injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Harris Hip Score (HHS)
Description
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).
Time Frame
Changes from baseline in Harris Hip Score to 1 month and 6 months.
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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'
Time Frame
Changes from baseline in Visual Analog Scale score to 1 month and 6 months.
Title
The Roles and maudsley (RM)
Description
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.
Time Frame
Changes from baseline in Roles and maudsley score to 1 month and 6 months.
Title
EuroQol five-dimensional questionnaire (EQ-5D-3L)
Description
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.
Time Frame
Changes from baseline in EuroQol five-dimensional questionnaire score to 1 month and 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Corum, MD
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
City
Istanbul
State/Province
Bahcelievler
ZIP/Postal Code
34180
Country
Turkey

12. IPD Sharing Statement

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

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