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Clinical Trials/CTRI/2024/04/065591
CTRI/2024/04/065591RecruitingPhase 2/3

Effect of 10% dextrose as an adjuvant in lumbar epidural adhesiolysis : a prospective randomized controlled study

AIIMS, New Delhi1 site in 1 country40 target enrollmentStarted: April 29, 2024Last updated:
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Trial Snapshot

Phase
Phase 2/3
Status
Recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
NRS for pain (on scale of 0-10)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Low back pain is a debilitating condition with a lifetime prevalence of 50-80% and results in severe biopsychosocial impact. Compression of nerves is common in low back pain leading to severe radicular pain and can be due to disc degeneration, spinal stenosis, inflammation and epidural adhesions. Post lumbar laminectomy syndrome or failed back surgery syndrome can affect up to 40% of patients and epidural fibrosis is thought to contribute to 60% of such cases . Adhesiolysis is a commonly performed procedure for such conditions which releases the nerve from entrapment. It is performed by a specialized spring coiled catheter (Racz catheter) which breaks the fibrous tissue my mechanical means and use of hyaluronidase. Epidural steroids are given afterwards to reduce inflammation, but may cause side effects like increases blood sugar levels, hypertension, water retention, lowering of immunity and infections. Dextrose is now being commonly employed for chronic pain conditions. The postulated mechanisms of dextrose in managing chronic pain include tissue regeneration, sensorineural effect, reduction of sensitization and hydrodissection All these factors may help in adhesiolysis procedure and attenuation of pain. We hypothesize that epidural administration of 10% dextrose would result in better pain relief than steroid after epidural adhesiolysis in patients with chronic lumbar radicular pain

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Low back with radicular pain more than 6 months with pain of 6 or more on 11 point NRS scale
  • •Radicular pain present post lumbar spine surgery evident by MRI imaging and clinical examination
  • •Failure to respond to conservative therapy and fluoroscopic guided epidural injections
  • •Filling defects observed on contrast injection during previous epidural steroid injections.

Exclusion Criteria

  • •Pain due to facet joint, sacroiliac joint or myofascial pain
  • •Sequestered disc
  • •Foraminal stenosis
  • •Allergy to contrast or local anesthetics
  • •Pregnant patients
  • •Bleeding or coagulation disorders
  • •Uncontrolled systemic disorders
  • •Opioid addiction of psychiatric disorders.

Outcomes

Primary Outcomes

NRS for pain (on scale of 0-10)

Time Frame: Preprocedure | 15 days, 1, 3 and 6 months post procedure

Secondary Outcomes

  • Oswestry Disability Index score(Preprocedure)
  • Successful outcome(Preprocedure)
  • Reduction in medication usage(Preprocedure)

Investigators

Sponsor
AIIMS, New Delhi
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dhruv Jain

All India Institute of Medical Sciences, New Delhi

Study Sites (1)

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