- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02039804
Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Sascha Colen, MD
- Phone Number: 0032-497180798
- Email: sascolen@hotmail.com
Study Locations
-
-
-
Leuven, Belgium, 3212
- University Hospitals Leuven
-
Contact:
- Sascha Colen, MD
- Phone Number: 00497-180798
- Email: sascolen@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Intra-bursal injection
Other Names:
|
Active Comparator: Corticosteroids
Injectable corticosteroids.
|
Intra-bursal injection
Other Names:
|
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
Investigators
- Principal Investigator: Sascha Colen, MD, Universitaire Ziekenhuizen KU Leuven
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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