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

NCT ID: NCT02039804

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-12-31

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

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Hyaluronic acid

Injectable hyaluronic acid.

Group Type: EXPERIMENTAL

Hyaluronic acid

Intervention Type: DEVICE

Intra-bursal injection

Corticosteroids

Injectable corticosteroids.

Group Type: ACTIVE_COMPARATOR

Corticosteroids

Intervention Type: DRUG

Intra-bursal injection

Interventions

Corticosteroids

Intra-bursal injection

Intervention Type: DRUG

Hyaluronic acid

Intra-bursal injection

Intervention Type: DEVICE

Other Intervention Names

Depo-Medrol 40mg; SportVis

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sascha Colen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sascha Colen, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

University Hospitals Leuven

Leuven, , Belgium

Countries

Belgium

Central Contacts

Sascha Colen, MD

Role: CONTACT

sascolen@hotmail.com

0032-497180798

Facility Contacts

Sascha Colen, MD

Role: primary

sascolen@hotmail.com

00497-180798

Other Identifiers

Trochanter Bursitis

Identifier Type: -

Identifier Source: org_study_id