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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
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tendinopathy Hip Pain Biological: PRP Biological: Whole Blood Device: Ultrasound Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: PRP Biological: PRP
Device: Ultrasound
Active Comparator: Whole Blood Biological: Whole Blood


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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".


Secondary Outcome Measures :
  1. 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".

  2. 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".

  3. 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".


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Peter Moley, M.D. Hospital for Special Surgery, New York
  Study Documents (Full-Text)

Documents provided by Hospital for Special Surgery, New York:
Study Protocol  [PDF] August 6, 2018
Statistical Analysis Plan  [PDF] August 6, 2018

More Information
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02978833    
Other Study ID Numbers: 2015-184
First Posted: December 1, 2016    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018
Last Verified: August 2018
Keywords provided by Hospital for Special Surgery, New York:
Gluteus Medius Tendinosis
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries