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

Completed

• Conditions: Adrenal Suppression

• Registration Number: NCT01799408
• Lead Sponsor: The Nazareth Hospital, Israel

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 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 Timeline

• Study Start: 2012-10
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-23
• Last Update Submitted: 2013-02-23
• Study First Posted: 2013-02-26
• Last Update Posted: 2013-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Osteoarthritis of the knee

Exclusion Criteria

• Had steroids in the last 3 months. Allergic to steroids

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adrenal Suppression	2 months	Adrenal gland suupresion and inability to adequately secrete cortisol in response to stress

Secondary Outcome Measures

Name	Time	Method
favorable clinical response	2 months
Favorable clinical response	2 months following the steroid injection	Improvement of knee pain by more than 30 points according to visual analogue scale