Do oral steroids help in controlling pain and swelling of joints in spondylo-arthritis?
- Conditions
- Health Condition 1: M469- Unspecified inflammatory spondylopathy
- Registration Number
- CTRI/2021/08/035887
- Lead Sponsor
- Post Graduate Institute of Medical education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Age =18 years and <60 years presence of axial SpA or peripheral SpA as per ASAS 2009 criteria.
2.Peripheral joint involvement= 2 swollen and tender both (currently) of 68 joint count.
3.Has received one NSAIDS for a total duration of 4 weeks with inadequate response.
4.Patient not affording biologicals recommended for the treatment for peripheral SpA.
1.Presence of poorly controlled diabetes defined by HbA1c >7%.
2.Presence of active infection/recurrent infection in the past or malignancy.
3.Recent fracture (within 6 months) or hip fracture(ever).
4.Pregnancy.
5. Intramuscular steroids less than 2 weeks before.
6.Uncontrolled hypertension, defined as more than 140/90 mm Hg on more than or equal to 3 drugs.
7. Patients with current psoriasis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving ACR 50 criteria at week 24.Timepoint: 0,12 and 24 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method Ankylosing Spondylitis Disease Activity Score(ASDAS)Timepoint: At 0,12 and 24 weeks;ASDAS NSAID indexTimepoint: At 0,12 and 24 weeks;Bath ankylosing spondylitis disease activity index(BASDAI)- a score which is calculated on the basis of 6 questions which the patient answers. We use the hindi validated version and numerical rating score 0-10 for this.Timepoint: At 0,12 and 24 weeks;Change in Dactylitis severity score -score ranging from 0-20 is the number of digits on hands and feet with dactylitis present. If dactylitis is present severity of pain due to dactylitis using NRS is also recordedTimepoint: At 0,12 and 24 weeks;Change in MASES score -The number of painful entheses out of 13 entheses.Timepoint: At 0,12 and 24 weeks;Safety analysis for screening of side effect profile of oral steroids over a period of 6 monthsTimepoint: At 12 and 24 weeks