A study to compare effectiveness of two approaches of the treatment named Transforaminal Epidural Steroid Injection (injection given in back) prescribed for patients of low back pain associated or not associated with leg pain and arising due to nerve compression between lower back bones.

Not Applicable

Completed

• Conditions: Health Condition 1: M997- Connective tissue and disc stenosis of intervertebral foraminaHealth Condition 2: null- Lumbar Radicular Pain radiating or non-radiating to lower limbs

• Registration Number: CTRI/2017/09/009711
• Lead Sponsor: Sir Sunderlal Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-06-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. The presence of lumbar radiculopathy

2. Nerve root compression in paracentral region at the level of supra-adjacent intervertebral disc

3. Single level TFESI from L1 to S1

4. No prior therapeutic TFESI

5. No prior surgery

6. Clear identification of the nerve root compression by using a cross sectional imaging study

Exclusion Criteria

1. Generalized inflammatory diseases

2. Previous use of anticoagulant agents

3. Uncontrollable diabetes that could lead to adverse effects from the steroid injections

4. Previous adverse effects from lidocaine and/or contrast Agents

5. Current suspected or diagnosed infection/sepsis

6. Poor general health, which would make it difficult for patient to visit hospital regularly

7. Injection site pathology

8. Cognitive limitations that would prevent the patient from completing the questionnaires

9. Cauda equina syndrome

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Verbal Numerical Rating Scale (VNRS). <br/ ><br>2. Oswestry Disability Index (ODI). <br/ ><br>3. Patient Satisfation Scale (PSS).Timepoint: 1 month and 3 months

Secondary Outcome Measures

Name	Time	Method
1. Verbal Numerical Rating Scale (VNRS). <br/ ><br>2. Oswestry Disability Index (ODI). <br/ ><br>3. Patient Satisfation Scale (PSS).Timepoint: 6 months