Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.

Phase 3

• Conditions: Osteoarthritis
• Interventions: Device: Hyaluronic acid; Drug: Corticosteroids

• Registration Number: NCT02039804
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Trochanteric pain can be caused by osteoarthritis of the hip, fracture, tendinitis, nerve pathology and trochanteric bursitis. Trochanteric bursitis is often seen at the outpatient clinic and is characterized by chronic lateral hip pain in the vicinity of the trochanter major, overlying the lateral aspect of the hip. When pain is persistent after conventional therapies, anesthetic and corticosteroid (CS) injections can provide short term to intermediate relief of pain, but relapse is common. Only one retrospective study showed the efficacy of intra-bursal trochanteric injections with HA and CS. They concluded that the pain release is significant with large effect sizes for both treatment. However, the efficacy of CS appeared to be short lived and it was shown that the efficacy of HA at 6 and 12 months is significant compared to CS (p\<0.05).

In this study we want to compare the efficacy of corticosteroids and hyaluronic acid in the treatment of trochanteric bursitis.

Detailed Description

See brief summary

Study Timeline

• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-20
• Status Verified: 2014-03
• Study Start: 2014-03
• Last Update Submitted: 2014-03-25
• Last Update Posted: 2014-03-26
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male or female, 18 years and older, but <75 years;
• VAS for pain > 30mm;
• Diagnosis of trochanteric bursitis as suggested by Brinks et al with symptoms for more than 3 months (3);
• Failure of conservative therapy of more than one month;
• Written informed consent;
• Available for the duration of the investigation.

Exclusion Criteria

• Previous surgery in the same region;
• Current other problem(s) in the affected extremity;
• Diabetes mellitus;
• Patient who received a local (CS) injection within 3 months from the baseline visit;
• Allergic or hypersensitive to CS or HA;
• Patients suffering (chronic) low back pain with or without sciatic pain;
• Patients with radiographic signs of moderate or severe hip osteoarthritis (Kellgren and Lawrence >1);
• Pregnant or lactating, or woman of childbearing potential not willing to use an acceptable method of contraception during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid	Hyaluronic acid	Injectable hyaluronic acid.
Corticosteroids	Corticosteroids	Injectable corticosteroids.

Primary Outcome Measures

Name	Time	Method
VAS for pain	26 weeks after administration

Secondary Outcome Measures

Name	Time	Method
VAS for pain	6 and 12 weeks after administration
Harris Hip Score	6, 12, 26 weeks

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium