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

Primary Purpose

Tendinopathy

Status

Active

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

platelet rich plasma

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring ultrasound;platelet-rich plasma;tendinopathy;pain;trochanter

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cruces University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Platelet rich plasma (PRP)

control

Arm Description

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

needle tenotomy with lidocaine

Outcomes

Primary Outcome Measures

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)

Number of adverse events related to treatment

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

Secondary Outcome Measures

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)

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

Pain changes assessed by visual analog scale (VAS)

Full Information

NCT ID

NCT04231357

First Posted

January 14, 2020

Last Updated

July 19, 2022

Sponsor

Isabel Andia

1. Study Identification

Unique Protocol Identification Number

NCT04231357

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 4, 2019 (Actual)

Primary Completion Date

November 20, 2022 (Anticipated)

Study Completion Date

April 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Isabel Andia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tendinopathy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Single center, superiority type, double blinded, randomised controlled study

Masking

ParticipantOutcomes Assessor

Masking Description

blocks of four, using EPIDAT3.1, and created aluminium 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, the syringe containing the treatment will be wrapped with gauze hindering treatment visualization.

Allocation

Randomized

Enrollment

89 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Platelet rich plasma (PRP)

Arm Type

Experimental

Arm Description

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

Arm Title

control

Arm Type

Active Comparator

Arm Description

needle tenotomy with lidocaine

Intervention Type

Drug

Intervention Name(s)

platelet rich plasma

Other Intervention Name(s)

PRP

Intervention Description

platelet rich plasma prepared from peripheral blood using single spin centrifugation

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

6 months

Title

Number of adverse events related to treatment

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Description

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)

Time Frame

3 and 12 months

Title

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

Description

Pain changes assessed by visual analog scale (VAS)

Time Frame

3, 6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Cruces University Hospital

City

Barakaldo

State/Province

Bizkaia

ZIP/Postal Code

48903

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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