Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.
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|ClinicalTrials.gov Identifier: NCT02039804|
Recruitment Status : Unknown
Verified March 2014 by Dr. Sascha Colen, Universitaire Ziekenhuizen Leuven.
Recruitment status was: Not yet recruiting
First Posted : January 20, 2014
Last Update Posted : March 26, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Drug: Corticosteroids Device: Hyaluronic acid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2015|
Experimental: Hyaluronic acid
Injectable hyaluronic acid.
Device: Hyaluronic acid
Other Name: SportVis
Active Comparator: Corticosteroids
Other Name: Depo-Medrol 40mg
- VAS for pain [ Time Frame: 26 weeks after administration ]
- Harris Hip Score [ Time Frame: 6, 12, 26 weeks ]
- VAS for pain [ Time Frame: 6 and 12 weeks after administration ]
- Patient's Global Assessment of Normal Function/Activity [ Time Frame: 6, 12, 26 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039804
|Contact: Sascha Colen, MDfirstname.lastname@example.org|
|University Hospitals Leuven|
|Leuven, Belgium, 3212|
|Contact: Sascha Colen, MD 00497-180798 email@example.com|
|Principal Investigator:||Sascha Colen, MD||Universitaire Ziekenhuizen Leuven|