Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Corticosteroids
Hyaluronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
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.
Sites / Locations
- University Hospitals Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hyaluronic acid
Corticosteroids
Arm Description
Injectable hyaluronic acid.
Injectable corticosteroids.
Outcomes
Primary Outcome Measures
VAS for pain
Secondary Outcome Measures
Harris Hip Score
VAS for pain
Full Information
NCT ID
NCT02039804
First Posted
July 24, 2013
Last Updated
March 25, 2014
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT02039804
Brief Title
Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.
Official Title
Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyaluronic acid
Arm Type
Experimental
Arm Description
Injectable hyaluronic acid.
Arm Title
Corticosteroids
Arm Type
Active Comparator
Arm Description
Injectable corticosteroids.
Intervention Type
Drug
Intervention Name(s)
Corticosteroids
Other Intervention Name(s)
Depo-Medrol 40mg
Intervention Description
Intra-bursal injection
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid
Other Intervention Name(s)
SportVis
Intervention Description
Intra-bursal injection
Primary Outcome Measure Information:
Title
VAS for pain
Time Frame
26 weeks after administration
Secondary Outcome Measure Information:
Title
Harris Hip Score
Time Frame
6, 12, 26 weeks
Title
VAS for pain
Time Frame
6 and 12 weeks after administration
Other Pre-specified Outcome Measures:
Title
Patient's Global Assessment of Normal Function/Activity
Time Frame
6, 12, 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sascha Colen, MD
Phone
0032-497180798
Email
sascolen@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sascha Colen, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3212
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sascha Colen, MD
Phone
00497-180798
Email
sascolen@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.
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