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

May 30, 2024 updated by: Isabel Andia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Cruces University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet rich plasma (PRP)
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
Drug: platelet rich plasma
platelet rich plasma prepared from peripheral blood using single spin centrifugation
Other Names:
  • PRP
Active Comparator: control
needle tenotomy with lidocaine
Drug: platelet rich plasma
platelet rich plasma prepared from peripheral blood using single spin centrifugation
Other Names:
  • PRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
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)
6 months
Number of adverse events related to treatment
Time Frame: 3 months
Differences in the patient self-reported adverse events related to treatment
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients that experience a significant minimal clinically important change in HOS at 3 and 12 months
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)
3 and 12 months
Pain changes (VAS) (0 to 10 maximum pain)
Time Frame: 3, 6 and 12 months
Pain changes assessed by visual analog scale (VAS)
3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isabel Andia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2019

Primary Completion (Actual)

January 27, 2023

Study Completion (Actual)

April 28, 2023

Study Registration Dates

First Submitted

January 14, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP-GTPS
  • 2019-000538-21 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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