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Greater Trochanteric Pain Syndrome: Efficacy of Ultrasound Guided Platelet-rich Plasma vs Needle Tenotomy. — PRP-GTPS  

Tendinopathy Clinical Trial

Official title:
Great Trochanteric Pain Syndrome: Parallel Group, Blind Randomised Clinical Trial to Assess the Efficacy and Safety of PRP Injection Versus Needle Tenotomy With Lidocaine

Clinical Trial Summary

Great trochanteric pain syndrome (GTPS) is a difficult problem to manage and result in significant patient morbidity. This study is a single-center, randomised double-blind controlled trial. Eighty patients will be allocated to have 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 outome measure: percent of patients that experience a reduction of 25% in hip outcome score (HOS) (responders) at 6 months after intervention. Secondary outcome measures include percent of responders at three and twelve months, pain reduction (VAS) at 3, 6 and 12 months. Adverse reactions or events will be recorded.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04231357
Study type Interventional
Source Basque Health Service
Contact
Status Active, not recruiting
Phase Phase 3
Start date December 4, 2019
Completion date April 28, 2023
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