TendinopathyPhase 4NCT02978833
Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy
A Phase 4 study testing PRP, Whole Blood and Ultrasound in people with Tendinopathy and Hip Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Tendinopathy, Hip Pain
- What is being tested?
- PRP, Whole Blood and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2013to Jun 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Ultrasound-Guided Platelet Rich Plasma Versus Whole Blood Injection for the Treatment of Gluteus Medius Tendinopathy: A Double-Blind Randomized Controlled Study
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.
- Conditions
- Tendinopathy, Hip Pain
- Being tested
- PRP, Whole Blood, Ultrasound
- Keywords
- Gluteus Medius Tendinosis
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
Whole BloodBiological
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| PRP | Experimental | Not described Receives: Biological: PRP; Device: Ultrasound |
| Whole Blood | Active comparator | Not described Receives: Biological: Whole Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year post-injection
Improvement in Function
The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.
Measured: Up to 1 year post-injection
Patient Satisfaction
The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from "very dissatisfied" to "extremely satisfied".
Measured: Up to 1 year post-injection
Secondary outcomes (3)
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".
Measured: Up to 1 year post-injection
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".
Measured: Up to 1 year post-injection
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".
Measured: Up to 1 year post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start1 Oct 2013
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: slow enrollment, lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Moley, M.D., Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978833
- Sponsor's protocol ID
- 2015-184
- Status last verified
- Aug 2018
- First submitted
- 29 Nov 2016
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Platelet Rich Plasma Versus Whole Blood Injection for the Treatment of Gluteus Medius Tendinopathy: A Double-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02978833
- Acronym / sponsor ID
- 2015-184
- Conditions
- Tendinopathy, Hip Pain
- Keywords
- Gluteus Medius Tendinosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment, lack of patients
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 1 Oct 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Posted 7 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Biological: PRP, Device: Ultrasound |
| Whole Blood | Active comparator | Biological: Whole Blood |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP | Biological | PRP |
| Whole Blood | Biological | Whole Blood |
| Ultrasound | Device | PRP |
Primary outcome
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".
3 secondary outcomes
Quality of Movement During the Forward Step-down Test
Time frame: Up to 1 year post-injection
Pain During Side-lying Hip Abduction
Time frame: Up to 1 year post-injection
Pain During Forward Step-down Test
Time frame: Up to 1 year post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Tendinopathy
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Rotator Cuff Tendonitis
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Synovial Tissue as a Biomarker in the Management of Pigmented Villonodular Synovitis
Synovitis Villonodular
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High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
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High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
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Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Moley, M.D. principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRP, Whole Blood and Ultrasound in people with Tendinopathy and Hip Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Pain (time frame: Up to 1 year post-injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.