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

March 25, 2014 updated by: Dr. Sascha Colen, Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

See brief summary

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3212
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic acid
Injectable hyaluronic acid.
Device: Hyaluronic acid
Intra-bursal injection
Other Names:
  • SportVis
Active Comparator: Corticosteroids
Injectable corticosteroids.
Drug: Corticosteroids
Intra-bursal injection
Other Names:
  • Depo-Medrol 40mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS for pain
Time Frame: 26 weeks after administration
26 weeks after administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Harris Hip Score
Time Frame: 6, 12, 26 weeks
6, 12, 26 weeks
VAS for pain
Time Frame: 6 and 12 weeks after administration
6 and 12 weeks after administration

Other Outcome Measures

Outcome Measure
Time Frame
Patient's Global Assessment of Normal Function/Activity
Time Frame: 6, 12, 26 weeks
6, 12, 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Sascha Colen, MD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 24, 2013

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trochanter Bursitis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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