Epidural Block in Axial Spondyloarthritis
Conditions
Brief summary
Study Design: A randomized, prospective, pilot, controlled trial. Setting: Rheumatology and rehabilitation department Minia University and Sohag University Objectives: To evaluate the effectiveness of caudal epidural injections with triamcinolone and lidocaine in managing limited spine mobility in axial SPA. Methods: Patients were randomly assigned to one of 2 groups, Group I patients received caudal epidural injections with 1% lidocaine hydrochloride (xylocaine AstraZeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip), whereas Group II patients did not receive. Both groups were age and sex matched and both were under treatment with anti TNF and NSAIDs with or without sDMARDs.
Interventions
DRUGEpidural block with lidocaine and triamcinilone
caudal epidural injections with 1% lidocaine hydrochloride (xylocaine AstraZeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip)
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* all participants fulfilled the ASAS criteria for axial SPA * all participants under treatment including bDMARDS and sDMARDs beside NSAIDs
Exclusion criteria
* Naive patients not under treatment * limitation of spine flexion due to non inflammatory causes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in pain | Baseline, after 2 weeks and after 8 weeks | visual analogue scale for pain minimum score 0 maximum score 10 |
| Change in functional ability of the patient | Baseline, after 2 weeks and after 8 weeks | Bath Ankylosing Spondylitis Functional Index (BASFI) minimum score 0 maximum 100, Oswestry Disability Index (ODI) minimum 0 no disability, maximum 100 means complete disability |
| Change in spinal mobility | Baseline, after 2 weeks and after 8 weeks | Bath AS Metrology Index (BASMI) minimum score 0 maximum 50, modified Schober test less than 5 cm yield means limited mobility, Lateral lumbar flexion more than 55 cm yield means limited lateral flexion |
| Change in ASDAS- CRP score | Baseline, after 2 weeks and after 8 weeks | ≥ 1.1 reduction in the initial score, less than 1.3 inactive disease, between 1.3 and 2.1 moderate, between 2.1-3.5 high disease activity, \> 3.5 very high disease activty |
Countries
Egypt
Outcome results
None listed