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

Greater Trochanteric Pain Syndrome Clinical Trial

Official title:

Radial Extracorporeal Shock Wave Therapy Versus Platelet-rich Plasma Injection for the Treatment of Greater Trochanteric Pain Syndrome With Gluteal Tendinopathy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04537091
• Other study ID #: 2020-309
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: January 5, 2021

Study information

• Verified date: September 2020
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 5, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gluteal Tendinopathy
• Greater Trochanteric Pain Syndrome
• Somatoform Disorders
• Syndrome
• Tendinopathy

Intervention

Procedure:
• 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
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine and Rehabilitation Training and Research Hospital	Istanbul	Bahcelievler

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analog Scale (VAS)	The self-evaluation of pain severity during rest and activity in the previous week was calculated using a 10-cm VAS scale, where 0 in the left corner of the scale represented 'no pain' and 10 in the right corner represented 'the worst pain that could be imagined'	Changes from baseline in Visual Analog Scale score to 1 month and 6 months.
Secondary	The Roles and maudsley (RM)	RM score was used to evaluate pain and activity limitation as classified in four categories: 1 point = excellent, 2 points = good, 3 points = fair, and 4 points = poor.	Changes from baseline in Roles and maudsley score to 1 month and 6 months.
Secondary	EuroQol five-dimensional questionnaire (EQ-5D-3L)	The EQ-5D-3L scale, which scores five health conditions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) through evaluation at 3 levels (no problems, some problems, or extreme problems), was used to evaluate the quality of life.	Changes from baseline in EuroQol five-dimensional questionnaire score to 1 month and 6 months.