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

Tendinopathy Clinical Trial

Official title:

Ultrasound-Guided Platelet Rich Plasma Versus Whole Blood Injection for the Treatment of Gluteus Medius Tendinopathy: A Double-Blind Randomized Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02978833
• Other study ID #: 2015-184
• Status: Terminated
• Phase: Phase 4
• Start date: October 1, 2013
• Est. completion date: June 2017

Study information

• Verified date: August 2018
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Pain
• Tendinopathy

Intervention

Biological:
• PRP

• Whole Blood

Device:
• Ultrasound

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 year post-injection
Primary	Improvement in Function	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
Primary	Patient Satisfaction	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	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".	Up to 1 year post-injection
Secondary	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".	Up to 1 year post-injection
Secondary	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".	Up to 1 year post-injection