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

NCT ID: NCT01799408

Last Updated: 2013-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Adrenal Suppression

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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betamethasone

Patients who had intra-articular injection of betamethasone

No interventions assigned to this group

Hyaluronic acid

Patients who had intra-articular injection of hyaluronic acid

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis of the knee

Exclusion Criteria

* Had steroids in the last 3 months. Allergic to steroids
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Nazareth Hospital, Israel

OTHER

Sponsor Role lead

Responsible Party

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George Habib

Head rheunatology clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George Habib, M.D.

Role: PRINCIPAL_INVESTIGATOR

Nazareth Hospital

Other Identifiers

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HPA-2012

Identifier Type: -

Identifier Source: org_study_id

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