Radial Extracorporeal Shock Wave Therapy Versus Platelet-rich Plasma Injection for Greater Trochanteric Pain Syndrome

NCT04537091 | Completed

• 1 other identifier: 2020-309
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Greater trochanteric pain syndrome (GTPS), is characterised by pain around the greater trochanter. Failure of first-line management for GTPS is followed by second-line treatments range from extracorporeal shock wave therapy (ESWT), corticosteroid or platelet-rich plasma (PRP) injections, and surgery. In a systematic reviews, PRP seems a viable effective and safe alternative option for GTPS after failed physical therapy. Also, positive results from previous systematic reviews involving radial ESWT (rESWT) as a treatment for GTPS. In the literature review, there is no comparison of the effectiveness of ESWT and PRP injection in patients with GTPS. The aim of this study was to investigate the effects of rESWT and PRP injection on pain, hip disability, and quality of life in patients with GTPS

Conditions

Gluteal Tendinopathy; Greater Trochanteric Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Harris Hip Score (HHS)

  The index consists of questions about pain and activities of daily living, referring to the previous week, and assessments of hip function (limping) and range of motion. Score ranges from 100 (no disability) to 0 (maximum disability).

  Changes from baseline in Harris Hip Score to 1 month and 6 months.

Secondary Outcomes (3)

• Visual Analog Scale (VAS)

  Changes from baseline in Visual Analog Scale score to 1 month and 6 months.

• The Roles and maudsley (RM)

  Changes from baseline in Roles and maudsley score to 1 month and 6 months.

• EuroQol five-dimensional questionnaire (EQ-5D-3L)

  Changes from baseline in EuroQol five-dimensional questionnaire score to 1 month and 6 months.

Study Arms (2)

ESWT group: rESWT

EXPERIMENTAL

rESWT treatment was applied to patients

Procedure: rESWT

PRP group: PRP injection

EXPERIMENTAL

PRP treatment was applied to patients

Procedure: PRP injection

Interventions

rESWT PROCEDURE

rESWT was administered once per week for 3 weeks with 4 bar pneumatic pressure, 10 Hz frequency, with 2000 pulses. Radial shock waves were transmitted to the greater trochanteric region with the maximum pain/tenderness that was identified with patients' reaction with small circular movements with an adequate amount of contact gel

ESWT group: rESWT

PRP injection PROCEDURE

PRP injection is performed with a high resolution 7-12-megahertz linear probe ultrasonography device. 15 ml of blood will be drawn from the patients and the blood will be centrifuged for 5 minutes. 4-5 ml PRP will be injected into the affected gluteal tendons accompanied by ultrasonography.

PRP group: PRP injection

Eligibility Criteria

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

You may qualify if:

• \> 18 years old
• Complaining of pain located anterior, lateral or posterior to the great trochanter for more than 3 months
• Pain while lying on the affected side
• Local tenderness on palpation of the area of the great trochanter
• MRI evidence of gluteus minimus or medius tendinopathy
• Refractory to conservative management

You may not qualify if:

• Presence of signs and symptoms of another cause of regional hip pain.
• Full-thickness tear of the involved gluteal tendons, bursa, and intra-articular structures
• Evidence of concomitant injury to the involved lower extremity, including radiculopathy or radiculitis, ischial tuberosity avulsion
• Severe knee or hip osteoarthritis
• Previous hip surgery or use of ESWT for GTPS.
• Acute low back pain
• Implanted pacemaker
• Vascular, neurologic, rheumatic diseases.
• Any neoplastic disorders
• Blood coagulation disorders or use of antiplatelet or anticoagulant drugs
• Pregnancy.

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Bahcelievler, 34180, Turkey (Türkiye)

Location

Study Officials

• Mustafa Corum, MD

  Istanbul Physical Medicine Rehabilitation Training & Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: September 3, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: January 5, 2021
• Last Updated: February 10, 2021

Record last verified: 2020-09

Locations

TU (1)