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

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

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

Study Overview

• Status: Completed
• Conditions: Adrenal Suppression

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 Type: Observational
• Enrollment (Actual): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with osteoarthritis of the knee and had not been onsteroids for at least 3 months

Description

Inclusion Criteria:

• Osteoarthritis of the knee

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
betamethasone; Patients who had intra-articular injection of betamethasone
Hyaluronic acid; Patients who had intra-articular injection of hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adrenal Suppression	Adrenal gland suupresion and inability to adequately secrete cortisol in response to stress	2 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Nadir serum cortisol level	2 months

Collaborators and Investigators

• Sponsor: The Nazareth Hospital, Israel
• Investigators: Principal Investigator: George Habib, M.D., Nazareth Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: February 21, 2013
• First Submitted That Met QC Criteria: February 23, 2013
• First Posted (Estimate): February 26, 2013

Study Record Updates

• Last Update Posted (Estimate): February 26, 2013
• Last Update Submitted That Met QC Criteria: February 23, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: HPA-2012