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

NCT ID: NCT04537091

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-01-05

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

Detailed Description

The pain and activities of daily living, referring to the previous week, and assessments of hip function (limping) and range of motion were evaluted by Harris Hip Score (HHS). The pain severity during rest and activity in the previous week was evaluted by Visual Analog Scale (VAS). The pain and activity limitation was evaluted by The Roles and maudsley (RM). The quality of life was evaluted by The EQ-5D-3L scale.

Conditions

Gluteal Tendinopathy; Greater Trochanteric Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

ESWT group: rESWT

rESWT treatment was applied to patients

Group Type: EXPERIMENTAL

rESWT

Intervention Type: 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

PRP group: PRP injection

PRP treatment was applied to patients

Group Type: EXPERIMENTAL

PRP injection

Intervention Type: 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.

Interventions

rESWT

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

Intervention Type: PROCEDURE

PRP injection

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• > 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mustafa Corum

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa Corum, MD

Role: STUDY_CHAIR

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Locations

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Bahcelievler, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2020-309

Identifier Type: -

Identifier Source: org_study_id