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OpenTrials
Completed

NCT Number: NCT01799408

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

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

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Key information

Conditions

Adrenal Suppression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Osteoarthritis of the knee

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Adrenal Suppression

    Time frame: 2 months

    Adrenal gland suupresion and inability to adequately secrete cortisol in response to stress

Secondary outcomes

  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 outcomes

  1. Nadir serum cortisol level

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

The Nazareth Hospital, Israel

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 26, 2013
Registry last updated
Feb 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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