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

NCT04231357 | Completed Phase 3

• 2 other identifiers: PRP-GTPS2019-000538-21
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tendinopathy

Keywords

ultrasound;platelet-rich plasma;tendinopathy;pain;trochanter

Outcome Measures

Primary Outcomes (2)

• 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

• Number of adverse events related to treatment

  Differences in the patient self-reported adverse events related to treatment

  3 months

Secondary Outcomes (2)

• Rate of patients that experience a significant minimal clinically important change in HOS at 3 and 12 months

  3 and 12 months

• Pain changes (VAS) (0 to 10 maximum pain)

  3, 6 and 12 months

Study Arms (2)

Platelet rich plasma (PRP)

EXPERIMENTAL

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

control

ACTIVE COMPARATOR

needle tenotomy with lidocaine

Drug: platelet rich plasma

Interventions

platelet rich plasma DRUG

platelet rich plasma prepared from peripheral blood using single spin centrifugation

Also known as: PRP

Platelet rich plasma (PRP); control

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Isabel Andia: lead

Study Sites (1)

Cruces University Hospital

Barakaldo, Bizkaia, 48903, Spain

Location

Related 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 Randomized Controlled Trial. Orthop J Sports Med. 2024 May 14;12(5):23259671241249123. doi: 10.1177/23259671241249123. eCollection 2024 May.

  PMID: 38751852 RESULT

Related Links

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

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: blocks of four, using EPIDAT3.1 statistical program, and created aluminum paper blinded envelopes with the numbered treatment allocation. The numbered envelopes will be opened on the treatment day by the researcher who is in charge of the PRP preparation. All physicians (including orthopaedists involved in clinical outcome assessments and radiologists involved in ultrasound assessments), except one radiologist who performed the procedures, will be unaware of treatment allocation. All patients will be blinded to the treatment. Peripheral blood will be drawn from all patients, and the syringe containing the treatment will be wrapped with gauze hindering treatment visualization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D.

Model Details: Single center, superiority type, double blinded, randomised controlled study

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: December 4, 2019
• Primary Completion: January 27, 2023
• Study Completion: April 28, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

ES (1)