Tendinopathy, Hip Pain
Conditions
Keywords
Gluteus Medius Tendinosis
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.
Interventions
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Pain | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Movement During the Forward Step-down Test | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Platelet-rich Plasma PRP
Ultrasound | 1 |
| Whole Blood Whole Blood | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated | 1 | 1 |
Baseline characteristics
| Characteristic | Platelet-rich Plasma | Whole Blood | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Improvement in Function
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
Population: This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.
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.
Time frame: Up to 1 year post-injection
Population: This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.
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.
Time frame: Up to 1 year post-injection
Population: This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.
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.
Time frame: Up to 1 year post-injection
Population: This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.
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.
Time frame: Up to 1 year post-injection
Population: This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.
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.
Time frame: Up to 1 year post-injection
Population: This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.