Cruces University Hospital
Barakaldo, Bizkaia, 48903, Spain
NCT Number: NCT04231357
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.
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Notify Me35 year–75 year
All sexes
Interventional
Phase 3
Barakaldo, Bizkaia, 48903, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
platelet rich plasma prepared from peripheral blood using single spin centrifugation
Other names: PRP
Time frame: 6 months
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)
Time frame: 3 months
Differences in the patient self-reported adverse events related to treatment
Time frame: 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)
Time frame: 3, 6 and 12 months
Pain changes assessed by visual analog scale (VAS)
Isabel Andia
Other Gov
Great Trochanteric Pain Syndrome: Parallel Group, Blind Randomised Clinical Trial to Assess the Efficacy and Safety of PRP Injection Versus Needle Tenotomy With Lidocaine
Acronym: PRP-GTPS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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