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

February 9, 2021 updated by: Mustafa Corum, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bahcelievler
      • Istanbul, Bahcelievler, Turkey, 34180
        • Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Harris Hip Score (HHS)
Time Frame: 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).
Changes from baseline in Harris Hip Score to 1 month and 6 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: 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'
Changes from baseline in Visual Analog Scale score to 1 month and 6 months.
The Roles and maudsley (RM)
Time Frame: 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.
Changes from baseline in Roles and maudsley score to 1 month and 6 months.
EuroQol five-dimensional questionnaire (EQ-5D-3L)
Time Frame: 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.
Changes from baseline in EuroQol five-dimensional questionnaire score to 1 month and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mustafa Corum, MD, Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-309

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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