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Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy

Primary Purpose

Tendinopathy, Hip Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PRP
Whole Blood
Ultrasound
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Gluteus Medius Tendinosis

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRP

Whole Blood

Arm Description

Outcomes

Primary Outcome Measures

Improvement in Pain
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
The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.
Patient Satisfaction
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

Quality of Movement During the Forward Step-down Test
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
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
Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".

Full Information

First Posted
November 29, 2016
Last Updated
August 6, 2018
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT02978833
Brief Title
Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment, lack of patients
Study Start Date
October 1, 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy, Hip Pain
Keywords
Gluteus Medius Tendinosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP
Arm Type
Experimental
Arm Title
Whole Blood
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Type
Biological
Intervention Name(s)
Whole Blood
Intervention Type
Device
Intervention Name(s)
Ultrasound
Primary Outcome Measure Information:
Title
Improvement in Pain
Description
The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.
Time Frame
Up to 1 year post-injection
Title
Improvement in Function
Description
The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.
Time Frame
Up to 1 year post-injection
Title
Patient Satisfaction
Description
The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from "very dissatisfied" to "extremely satisfied".
Time Frame
Up to 1 year post-injection
Secondary Outcome Measure Information:
Title
Quality of Movement During the Forward Step-down Test
Description
The quality of movement will be assessed on a scale of 0-4+, where 4+="good", 2-3="moderate", and 0-1="poor".
Time Frame
Up to 1 year post-injection
Title
Pain During Side-lying Hip Abduction
Description
Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".
Time Frame
Up to 1 year post-injection
Title
Pain During Forward Step-down Test
Description
Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".
Time Frame
Up to 1 year post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Moley, M.D.
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy

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