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

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. Identifier: NCT01799408
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
Information provided by (Responsible Party):
George Habib, 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

Condition or disease
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.

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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 : October 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Patients who had intra-articular injection of betamethasone
Hyaluronic acid
Patients who had intra-articular injection of hyaluronic acid

Primary Outcome Measures :
  1. Adrenal Suppression [ Time Frame: 2 months ]
    Adrenal gland suupresion and inability to adequately secrete cortisol in response to stress

Secondary Outcome Measures :
  1. favorable clinical response [ Time Frame: 2 months ]
  2. 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

Other Outcome Measures:
  1. Nadir serum cortisol level [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with osteoarthritis of the knee and had not been onsteroids for at least 3 months

Inclusion Criteria:

  • Osteoarthritis of the knee

Exclusion Criteria:

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

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 identifier (NCT number): NCT01799408

Sponsors and Collaborators
The Nazareth Hospital, Israel
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Principal Investigator: George Habib, M.D. Nazareth Hospital
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Responsible Party: George Habib, Head rheunatology clinic, The Nazareth Hospital, Israel Identifier: NCT01799408    
Other Study ID Numbers: HPA-2012
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013