comparison of ultrasound and fluoroscopic guided facet joint injection in low back pain patients due to facet joint involvement

Not yet recruiting

Conditions: Primary osteoarthritis of other joints,

Registration Number: CTRI/2022/09/046007

Lead Sponsor: All India institute of medical sciences Rishikesh

Brief Summary: | |

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|Lumbar facet joints have been implicated in the cause of chronic low back pain in 15% to 45% of patients, which was based upon their responses toward controlled, diagnostic blocks according to the criteria set by the International Association for the Study of Pain. Treatment effects for facet join pain in 3 types of intervention, including intraarticular injection, medial branch nerve block, and neurolysis using radiofrequency, have been reported. These treatment options have been implicated in refractory cases of facet joint pain who are not responsive to conservative management. Appropriate management methods for the facet joint pain are still in argument. Facet joint intra-articular (IA) injection are conventionally and preferably performed under fluoroscopy (FL) or computed tomography (CT)-guided. Both guidance modalities deliver significant radiation doses and require, at least in part, expensive equipment. However, an ultrasound (US)-guided approach can be safe and reliable without radiation exposures. Recently, many studies have demonstrated the reliability of ultrasound (US) guidance for different spinal injections. Ultrasound provides real-time monitoring, is a relatively inexpensive image guidance modality, does not produce ionizing radiation, and is broadly available.

We hypothesized that US-guided facet IA injection provides non-inferior analgesic efficacy and functional outcome as compared to conventional FL-guided injection without any risk of radiation exposure with added advantages of cost-effective, feasible, easily accessible, portable, and real time visualization of needle and surrounding structure.

Very few trials have been conducted till date. Therefore,we planned this trial with the aim to evaluate the comparative efficacy of thetwo different image-guided (US-guided and FL-guided) modalities in performingfacet joint intra-articular (IA) injections in patients with chronic lumbar facetjoint syndrome in terms of pain relief and quality of life improvement

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 94

Inclusion Criteria

Chronic LBP with or without proximal non-radicular extremity pain 2.
Duration of pain at least more than 3 months 3.
Pain unresponsive to conservative treatment including medical management, physical therapy, and previous interventions.
Average pain score of â‰¥4 on an 11-point NRS.

Exclusion Criteria

Patient refusal 2.
more than one facet joint or bilateral facet joint involvement 3.
Pain for less than 3 months 4.
Coagulopathy and/or patients on anticoagulants.
Infection at the site of injection.
Hypersensitivity to local anesthetic agent.
Evidence of significant progressive sensory or motor deficit, cauda-equina syndrome, H/O trauma, infection and cancer (Red flag signs).
Evidence of severe psychiatric illness.
History of spinal tumor, spinal cord injury or previous backs surgery 10.History of any major comorbid medical conditions, those interfere with recording of study outcomes (neurological disorders, auto-immune diseases), multiple sclerosis, and pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score [11-point numeric rating scale (NRS 11) score] in both the groups	1 week, 1 month, 3 months

Secondary Outcome Measures

Name	Time	Method
1. GPE (Global Perceived Effect) as measured by Likert scale 7-point scoring system to assess patient satisfaction and improvement.	2. Improvement in functional status as measured by Ronald Morris Questionnaire at respective time intervals.

Trial Locations

Locations (1): Room no 16, pain division, Anaesthesiology department
🇮🇳
Dehradun, UTTARANCHAL, India
Room no 16, pain division, Anaesthesiology department
🇮🇳Dehradun, UTTARANCHAL, India
Dr Ajit Kumar
Principal investigator
9910789377
ajitdr.ajit@gmail.com