Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02978833|
Recruitment Status : Terminated (slow enrollment, lack of patients)
First Posted : December 1, 2016
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Tendinopathy Hip Pain||Biological: PRP Biological: Whole Blood Device: Ultrasound||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Ultrasound-Guided Platelet Rich Plasma Versus Whole Blood Injection for the Treatment of Gluteus Medius Tendinopathy: A Double-Blind Randomized Controlled Study|
|Study Start Date :||October 1, 2013|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
|Active Comparator: Whole Blood||
Biological: Whole Blood
- 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.
- 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.
- 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".
- 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".
- 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".
- 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".
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||30 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978833
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Peter Moley, M.D.||Hospital for Special Surgery, New York|
Documents provided by Hospital for Special Surgery, New York:
|Responsible Party:||Hospital for Special Surgery, New York|
|Other Study ID Numbers:||
|First Posted:||December 1, 2016 Key Record Dates|
|Results First Posted:||August 7, 2018|
|Last Update Posted:||August 7, 2018|
|Last Verified:||August 2018|
Gluteus Medius Tendinosis
Wounds and Injuries