Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy
August 6, 2018 updated by: Hospital for Special Surgery, New York
Ultrasound-Guided Platelet Rich Plasma Versus Whole Blood Injection for the Treatment of Gluteus Medius Tendinopathy: A Double-Blind Randomized Controlled Study
Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by side lying, stair climbing, and walking.
Treatment is currently limited to lifestyle modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical repair.
Platelet rich plasma (PRP) injections contain important growth factors that are essential in the healing and tissue formation processes.
However, the extent to which PRP is more efficacious than whole blood in tendinopathy remains unclear.
In this double-blind randomized trial, patients will be allocated to receive either a PRP or whole-blood injection.
Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months, and 1 year.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 4
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
-
-
New York
-
New York, New York, United States, 10021
- Hospital for Special Surgery
-
-
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
Ages Eligible for Study
30 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Moderate to severe lateral hip pain for greater than 3 months
- Symptoms are refractory to conservative treatment, including at least 8 weeks of traditional physical therapy for this condition
- Moderate to severe gluteus medius tendinosis with or without partial tear <1 cm
- Normal neurologic exam except for hip abductor weakness on the affected side
Exclusion Criteria:
- Severe (Tonnis grade >1) hip osteoarthritis with active synovitis or bone edema
- Active lumbar radiculopathy with pain, numbness or weakness in a dermatomal distribution
- No evidence of fatty atrophy, denervation, or complete tears of gluteus medius seen on MRI
- Any condition that requires anti-platelet or anti-coagulation therapy, including aspirin therapy for cardiac conditions
- Non-English speaking
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: PRP
|
|
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ACTIVE_COMPARATOR: Whole Blood
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in Pain
Time Frame: Up to 1 year post-injection
|
The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain.
A higher number represents more pain.
|
Up to 1 year post-injection
|
|
Improvement in Function
Time Frame: Up to 1 year post-injection
|
The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.
|
Up to 1 year post-injection
|
|
Patient Satisfaction
Time Frame: Up to 1 year post-injection
|
The 10-cm Visual Analog Scale for patient satisfaction will be used.
This scale will range from "very dissatisfied" to "extremely satisfied".
|
Up to 1 year post-injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Movement During the Forward Step-down Test
Time Frame: Up to 1 year post-injection
|
The quality of movement will be assessed on a scale of 0-4+, where 4+="good", 2-3="moderate", and 0-1="poor".
|
Up to 1 year post-injection
|
|
Pain During Side-lying Hip Abduction
Time Frame: Up to 1 year post-injection
|
Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".
|
Up to 1 year post-injection
|
|
Pain During Forward Step-down Test
Time Frame: Up to 1 year post-injection
|
Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".
|
Up to 1 year post-injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peter Moley, M.D., Hospital for Special Surgery, New York
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
October 1, 2013
Primary Completion (ACTUAL)
June 1, 2017
Study Completion (ACTUAL)
June 1, 2017
Study Registration Dates
First Submitted
November 29, 2016
First Submitted That Met QC Criteria
November 30, 2016
First Posted (ESTIMATE)
December 1, 2016
Study Record Updates
Last Update Posted (ACTUAL)
August 7, 2018
Last Update Submitted That Met QC Criteria
August 6, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-184
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.