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Intra-articular Betamethasone and the Hypothalamic-pituitary-adrenal Axis

Sponsor
The Nazareth Hospital, Israel (Other)
Overall Status
Completed
CT.gov ID
NCT01799408
Collaborator
(none)
40
Enrollment
4
Duration (Months)

Study Details

Study Description

Brief Summary

To evaluate the effect of intra-articular corticosteroid injection (IACI) of depot preparation of betamethasone on the hypothalamic-pituitary-adrenal (HPA) axis, in patients with osteoarthritis of the knee

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Consecutive patients attending the rheumatology or orthopedic clinic with osteoarthritic knee pain, not responding satisfactorily to medical or physical therapy were allocated to group-1 after consent and given IACI of 6 mg of betamethasone acetate/betamethasone sodium phosphate. Following completion of this part, consecutive age- and sex-matched patients were allocated to group-2 and given intra-articular injection of 60 mg of sodium hyaluronate. Just prior to the knee injection and 1, 2, 3, 4 and 8 weeks later, patients had 1 µg adrenocorticotropin hormone (ACTH) stimulation test. Secondary adrenal insufficiency (SAI) was defined as levels of less than 18 ng/ml or a rise of < than 7 ng/ml of serum cortisol, 30 minutes following the ACTH stimulation test.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Intra-articular Injection of Betamethasone Acetate/Betamethasone Sodium Phosphate at the Knee Joint on the Hypothalamic-pituitary-adrenal Axis: a Case Controlled Study
    Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Feb 1, 2013
    Actual Study Completion Date :
    Feb 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    betamethasone

    Patients who had intra-articular injection of betamethasone
    Hyaluronic acid

    Patients who had intra-articular injection of hyaluronic acid

    Outcome Measures

    Primary Outcome Measures

    1. Adrenal Suppression [2 months]

      Adrenal gland suupresion and inability to adequately secrete cortisol in response to stress

    Secondary Outcome Measures

    1. favorable clinical response [2 months]

    2. Favorable clinical response [2 months following the steroid injection]

      Improvement of knee pain by more than 30 points according to visual analogue scale

    Other Outcome Measures

    1. Nadir serum cortisol level [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Osteoarthritis of the knee
    Exclusion Criteria:
    • Had steroids in the last 3 months. Allergic to steroids

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The Nazareth Hospital, Israel

    Investigators

    • Principal Investigator: George Habib, M.D., Nazareth Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    George Habib, Head rheunatology clinic, The Nazareth Hospital, Israel
    ClinicalTrials.gov Identifier:
    NCT01799408
    Other Study ID Numbers:
    • HPA-2012
    First Posted:
    Feb 26, 2013
    Last Update Posted:
    Feb 26, 2013
    Last Verified:
    Feb 1, 2013

    Study Results

    No Results Posted as of Feb 26, 2013