Clinical trial NCT04537091: Radial Extracorporeal Shock Wave Therapy Versus Platelet-rich Plasma Injection for Greater Trochanteric Pain Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gluteal Tendinopathy
Greater Trochanteric Pain Syndrome
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-09-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: Changes from baseline in Harris Hip Score to 1 month and 6 months.
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Changes from baseline in Visual Analog Scale score to 1 month and 6 months.
measure: The Roles and maudsley (RM)
timeFrame: Changes from baseline in Roles and maudsley score to 1 month and 6 months.
measure: EuroQol five-dimensional questionnaire (EQ-5D-3L)
timeFrame: Changes from baseline in EuroQol five-dimensional questionnaire score to 1 month and 6 months.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
state: Bahcelievler
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
name: Mustafa Corum, MD
role: STUDY_CHAIR
References: