NCT04215757

Brief Summary

Low back pain is one of the most common ailments that plagues patients, with nearly 80% of the population developing some form of back pain in their lifetime. Up regulated sodium channels in the nerve root or dorsal root ganglion are the basic cause for the mechano-sensitization and injecting the drug in the peripheral end of the nerve will block these sodium channels, since functionally both ends of the pseudo unipolar neuron are the same.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

12 months

First QC Date

December 30, 2019

Last Update Submit

December 30, 2019

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

  • ≥50% or ≥4 point reduction in an 10-point numeric scale (NRS) at, 1 month, 2 months and 3 months.

    change in pain intensity measured with numeric scale.Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an ten-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Patient received one or two peripheral nerve blocks at a maximum according to their involvement in the operation theatre, with full ASA monitoring under all aseptic precautions. For L4 radiculopathy Saphenous nerve block with 1.5ml of 2% lignocaine diluted to 10ml (0.3%) For L5 radiculopathy Deep peroneal nerve block/posterior tibial nerve block with 1.5ml of 2% lignocaine diluted to 10ml (0.3%) For S1 radiculopathy Sural nerve block with 1.5ml of 2% lignocaine diluted to 10ml (0.3%)

Procedure: peripheral nerve block

Control group

PLACEBO COMPARATOR

Patients received one or two peripheral nerve blocks at a maximum according to their involvement in the operation theatre, with full ASA monitoring under all aseptic precautions. For L4 radiculopathy Saphenous nerve block with 10ml distilled water For L5 radiculopathy Deep peroneal nerve block/posterior tibial nerve block with 10ml distilled water For S1 radiculopathy Sural nerve block with10ml distilled water

Procedure: peripheral nerve block

Interventions

peripheral nerve blockPROCEDURE

peripheral nerve blocks with low dose lignocaine in acute radiculopathy

Control groupIntervention group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 years to 60 years
  • Pain involving up to two segmental levels (L4, L5 and S1).
  • Average pain score of ≥5 on an 11-point NRS.
  • Tenderness over the concordant peripheral nerves (Gore sign +)
  • Computed tomography/Magnetic resonance imaging evidence of nerve root pain concordant with the side and level of clinical features.

You may not qualify if:

  • Coagulopathy and/or patients on anticoagulants.
  • Infection at the site of injection.
  • Hypersensitivity to a local anaesthetic agent.
  • Evidence of significant sensory or progressive motor deficit.
  • Presence of cancer as a cause of back pain.
  • History of previous backs surgery/epidural steroid injection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIIMS

Rishikesh, Uttarakhand, 249203, India

RECRUITING

Related Publications (1)

  • Levinson SR, Luo S, Henry MA. The role of sodium channels in chronic pain. Muscle Nerve. 2012 Aug;46(2):155-65. doi: 10.1002/mus.23314.

    PMID: 22806363RESULT

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vijay Adabala, MD

    AIIMS Rishikesh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AJIT KUMAR, MD

CONTACT

9910789377ajitdr.ajit@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 2, 2020

Study Start

January 20, 2019

Primary Completion

January 15, 2020

Study Completion

January 30, 2020

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

once the study is finished

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
6 months
Access Criteria
on web

Locations

IN(1)