Effects of Ultrasound and Fluoroscopy guided injection in Ankylosing Spondylitis and related diseases.

Phase 1

Not yet recruiting

Brief Summary: This study is a randomized, double blinded, parallel group, single centered interventional trial comparing the clinical effect of ultrasound and fluoroscopy guided injection ofcorticosteroid in sacroiliac joint in terms of pain reduction and improvement ofdisability arising from lower back pain in patients of spondyloarthropathy. This study will be conducted in only one center (in India). The primary outcome measurements are change of severity of pain measured by using the NRS score (0-10) and disability due to lower back pain by Oswestrydisability index in baseline (visit 0), at 1 week (visit 1), 4 weeks (visit 2), 12 weeks (visit3).

Recruitment & Eligibility

Inclusion Criteria

Diagnosed case of seronegative Spondyloarthropathy by ASAS criteria.
Pain primarily experienced between the upper level of the iliac crests and the gluteal fold.
Active sacroilitis clinically (positive finding of at least 3 of 6 following tests for SIJ pain) i.
Distraction or â€œGappingâ€ ii.
FABER/Patrickâ€™s Test iii.
Thigh Thrust or Posterior Pelvic Pain Provocational Test iv.
Gaenslenâ€™s Test v.
Sacroiliac Joint Compression Test vi.
Sacral Thrust or Yeomanâ€™s Test.
Poorly controlled by conservative treatment for 1 month by means of both pharmacological and non-pharmacological therapy.
Age between 18-45 years.
Oswestry disability index > 40% 7.
Reduction of pain intensity by > 75% following a diagnostic injection.
Unilateral sacroilitis.

Exclusion Criteria

Severe peripheral arthritis with hip involvement.
Clinical findings and imaging studies suggest other obvious cause of the pain (e.g., central spinal stenosis with neurogenic claudication/myelopathy, foraminal stenosis or disc herniation with concordant radicular pain/radiculopathy, pyriformis syndrome, infection, tumour, fracture, pain related to spinal instrumentation).
Degenerative sacroiliac joint or complete ankylosis of sacroiliac joint (Grade IV).
Patient assume prone lying position to be difficult.
Allergy to lignocaine, contrast dye.
Presence of coagulation disorder or receiving anti-coagulant therapy.
With other systemic disorders or active infection or other contraindications for corticosteroid injection.
Unwilling patient.
Patient unable to come to hospital for subsequent visits for follow-up.
Has psychiatric disorder.
H/o prior injection in SIJ within 2 months.

Primary Outcome Measures

Name	Time	Method
1.Severity of sacroiliac joint pain - measured by NRS (Numeric Rating Scale) [0-10]	Baseline \| 1 Week \| 4 Weeks \| 12 Weeks

Secondary Outcome Measures

Name	Time	Method
Disability due to low back pain - measured by Oswestry disability index	Baseline

Locations (1): R. G. Kar Medical College and Hospital
🇮🇳
Kolkata, WEST BENGAL, India
R. G. Kar Medical College and Hospital
🇮🇳Kolkata, WEST BENGAL, India
Dr Debajyoti Ghosh
Principal investigator
9153093649
ghosh.debajyoti2010@gmail.com