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

• Status: Recruiting
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isabel Andia
• Treatments: Lidocaine

Criteria

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 five years.

• Analytical Diagnosis Hepatitis B, C or HIV infection.

• Pregnant or lactating.

• People who are taking a drug in clinical investigation or participated in any investigational study clinic (with an authorized or not) within 30 days prior to randomization.