Clinical Trial: Intra-articular Betamethasone and the Hypothalamic-pituitary-adrenal Axis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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

Detailed Summary: 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.
Sponsor: The Nazareth Hospital, Israel

Current Primary Outcome: Adrenal Suppression [ Time Frame: 2 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • favorable clinical response [ Time Frame: 2 months ]
  • Favorable clinical response [ Time Frame: 2 months following the steroid injection ]
    Improvement of knee pain by more than 30 points according to visual analogue scale


Original Secondary Outcome: Same as current

Information By: The Nazareth Hospital, Israel

Dates:
Date Received: February 21, 2013
Date Started: October 2012
Date Completion:
Last Updated: February 23, 2013
Last Verified: February 2013