Greater Trochanteric Pain Syndrome: Efficacy of Ultrasound Guided Platelet-rich Plasma vs Needle … (NCT04231357) | Clinical Trial Compass
CompletedPhase 3
Greater Trochanteric Pain Syndrome: Efficacy of Ultrasound Guided Platelet-rich Plasma vs Needle Tenotomy.
Spain81 participantsStarted 2019-12-04
Plain-language summary
Great trochanteric pain syndrome (GTPS) is a difficult problem to manage and results in significant patient morbidity. This study is a single-center, randomized double-blind controlled trial. Eighty patients will be allocated to have an ultrasound (US)-guided injection of pure platelet-rich plasma (PRP) or needle tenotomy. Outcome data will be collected before the intervention, and at 3, 6, and 12 months after intervention. Main outcome measure: percent of patients that experience a reduction of 25% in hip outcome score (HOS) (responders) at 6 months after the intervention. Secondary outcome measures include percent of responders at three and twelve months, and pain reduction (VAS) at 3, 6, and 12 months. Adverse reactions or events will be recorded.
Who can participate
Age range
35 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients of both sexes between the ages of 35 and 75 years.
* At the screening visit, they present hip pain at 3 points out of 10 in EVA.
* Body Mass Index values between 20 and 35 (both values included).
* Commitment to comply with all study procedures.
* Diagnoses of chronic GTPS according to the diagnostic criteria that have been previously described.
* The patient must give written informed consent.
* Women of child-bearing age must obtain a negative test result of pregnancy in blood or urine and accept the use of appropriate contraception while in the trial.
Exclusion Criteria:
* • Body Mass Index\>35.
* Presence of full tendon tear.
* Systemic autoimmune rheumatologic disease (connective tissue diseases and systemic necrotizing vasculitis)
* Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%)
* Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb \<9)
* Patients receiving immunosuppressive treatments
* Treatment by intramuscular corticoid, during the 3 months prior to the first administration of the trial treatment.
* Treatment with non-steroidal anti-inflammatory drugs (more than 10 days consecutive to usual doses), opiates or oral steroids during the 15 days prior to treatment in the study.
* Severe heart disease
* Patients unable to comply with scheduled visits, for work or spend long periods away from their habitual residence.
* Patients with active cancer or cancer diagnosed in the last fiv…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of participants that showed a clinically minimal clinically important change in function as measured by HOS (Hip Outcome Score, Activity of Daily Living Scale)