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

Tendinopathy Clinical Trial

— PRP-GTPS  

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 Details — Status: Completed

Administrative data

• NCT number: NCT04231357
• Other study ID #: PRP-GTPS
• Secondary ID: 2019-000538-21
• Status: Completed
• Phase: Phase 3
• Start date: December 4, 2019
• Est. completion date: April 28, 2023

Study information

• Verified date: May 2024
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 28, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Drug:
• platelet rich plasma
platelet rich plasma prepared from peripheral blood using single spin centrifugation

Locations

Country	Name	City	State
Spain	Cruces University Hospital	Barakaldo	Bizkaia

Sponsors (1)

Lead Sponsor	Collaborator
Isabel Andia

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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 Random — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of adverse events related to treatment	Differences in the patient self-reported adverse events related to treatment	3 months
Secondary	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
Secondary	Pain changes (VAS) (0 to 10 maximum pain)	Pain changes assessed by visual analog scale (VAS)	3, 6 and 12 months

External Links

•   here is a link to the open access article containing the clinical trial results