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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Dr. Sascha Colen, Universitaire Ziekenhuizen Leuven

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Corticosteroids Device: Hyaluronic acid Phase 3

Detailed Description:
See brief summary

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bursitis Steroids

Arm Intervention/treatment
Experimental: Hyaluronic acid
Injectable hyaluronic acid.
Device: Hyaluronic acid
Intra-bursal injection
Other Name: SportVis

Active Comparator: Corticosteroids
Injectable corticosteroids.
Drug: Corticosteroids
Intra-bursal injection
Other Name: Depo-Medrol 40mg




Primary Outcome Measures :
  1. VAS for pain [ Time Frame: 26 weeks after administration ]

Secondary Outcome Measures :
  1. Harris Hip Score [ Time Frame: 6, 12, 26 weeks ]
  2. VAS for pain [ Time Frame: 6 and 12 weeks after administration ]

Other Outcome Measures:
  1. Patient's Global Assessment of Normal Function/Activity [ Time Frame: 6, 12, 26 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Sascha Colen, MD 0032-497180798 sascolen@hotmail.com

Locations
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Belgium
University Hospitals Leuven
Leuven, Belgium, 3212
Contact: Sascha Colen, MD    00497-180798    sascolen@hotmail.com   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Sascha Colen, MD Universitaire Ziekenhuizen Leuven
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Responsible Party: Dr. Sascha Colen, MD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02039804    
Other Study ID Numbers: Trochanter Bursitis
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Methylprednisolone Acetate
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Anti-Inflammatory Agents