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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000538-21 | EudraCT Number |
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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.
Evaluation of gluteal tendon pathology, including superoposterior and lateral aspects of gluteus medius and gluteus minimus(changes in echotexture, partial tears, calcified deposits, thickness, and loss of fibrillar pattern were evaluated by ultrasound at baseline, six and 12 m post-treatment. Peritrochanteric pathology including tensor fascia lata, trochanteric bursa, and cortical irregularities were also recorded. To analyze the relationship between the possible predictor variables (including sociodemographic and clinical factors, and imaging biomarkers, such as tendon degeneration and abnormalities in the peritrochanteric space) and changes in pain (VAS score) and functionality (HOS score), multivariate analyses were performed using multiple linear regressions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet rich plasma (PRP) | Experimental | 3 mL of autologous platelet rich plasma with a moderate concentration of platelet (2x above peripheral blood) and no leukocytes will be injected under ultrasound guidance |
|
| control | Active Comparator | needle tenotomy with lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| platelet rich plasma | Drug | platelet rich plasma prepared from peripheral blood using single spin centrifugation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Rate of participants that experience at least 25% change in Hip Outcome score (HOS) (comparing to baseline) (Hip Outcome Score, Activity of Daily Living Scale, 0 (worst) to 100 (level of activity prior to hip problem) | 6 months |
| Number of adverse events related to treatment | Differences in the patient self-reported adverse events related to treatment | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients that experience a significant minimal clinically important change in HOS at 3 and 12 months | Rate of patients that experience at least 25% change in Hip Outcome score (HOS, Activity of Daily Living Scale, 0 to 100 (level of activity prior to hip problem) | 3 and 12 months |
| Pain changes (VAS) (0 to 10 maximum pain) |
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Inclusion Criteria:
Exclusion Criteria:
• Body Mass Index>35.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cruces University Hospital | Barakaldo | Bizkaia | 48903 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38751852 | Result | Atilano L, Martin N, Ignacio Martin J, Iglesias G, Mendiola J, Bully P, Aiyegbusi A, Manuel Rodriguez-Palomo J, Andia I. Ultrasound-Guided Subfascial Platelet-Rich Plasma Injections Versus Enthesis Needling for Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial. Orthop J Sports Med. 2024 May 14;12(5):23259671241249123. doi: 10.1177/23259671241249123. eCollection 2024 May. |
| Label | URL |
|---|---|
| here is a link to the open access article containing the clinical trial results | View source |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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Single center, superiority type, double blinded, randomised controlled study
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blocks of four, using EPIDAT3.1 statistical program, and created aluminum paper blinded envelopes with the numbered treatment allocation. The numbered envelopes will be opened on the treatment day by the researcher who is in charge of the PRP preparation. All physicians (including orthopaedists involved in clinical outcome assessments and radiologists involved in ultrasound assessments), except one radiologist who performed the procedures, will be unaware of treatment allocation. All patients will be blinded to the treatment. Peripheral blood will be drawn from all patients, and the syringe containing the treatment will be wrapped with gauze hindering treatment visualization.
Pain changes assessed by visual analog scale (VAS) |
| 3, 6 and 12 months |