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

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ClinicalTrials.gov Identifier: NCT01799408
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
Sponsor:
Information provided by (Responsible Party):
George Habib, The Nazareth Hospital, Israel

Study Description
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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.
Study Design
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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

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Groups and Cohorts
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Group/Cohort
betamethasone
Patients who had intra-articular injection of betamethasone
Hyaluronic acid
Patients who had intra-articular injection of hyaluronic acid


Outcome Measures
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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 ]

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Osteoarthritis of the knee

Exclusion Criteria:

  • Had steroids in the last 3 months. Allergic to steroids
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01799408


Sponsors and Collaborators
The Nazareth Hospital, Israel
Investigators
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Principal Investigator: George Habib, M.D. Nazareth Hospital
More Information
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Responsible Party: George Habib, Head rheunatology clinic, The Nazareth Hospital, Israel
ClinicalTrials.gov 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