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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01799408
Enrollment
40
Registered
2013-02-26
Start date
2012-10-31
Completion date
2013-02-28
Last updated
2013-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Suppression

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

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.

Interventions

None listed

Sponsors

The Nazareth Hospital, Israel
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Osteoarthritis of the knee

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Adrenal Suppression2 monthsAdrenal gland suupresion and inability to adequately secrete cortisol in response to stress

Secondary

MeasureTime frameDescription
favorable clinical response2 months
Favorable clinical response2 months following the steroid injectionImprovement of knee pain by more than 30 points according to visual analogue scale

Other

MeasureTime frame
Nadir serum cortisol level2 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026