NCT02387567

Brief Summary

The purpose of this study is to investigate the effects of a treatment involving the application of lidocaine injected on the low back area for pain control. The study will compare this form of treatment with other options such as physical exercises or pain killer medication, different measurements are going to be used to quantify the response to each of these treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
378

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2007

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

6 years

First QC Date

May 22, 2014

Last Update Submit

March 12, 2015

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in pain on the visual analog scale (VAS) score for pain at week 1

    Baseline, week 1

Secondary Outcomes (3)

  • Change from baseline in pain on the Brazilian Roland-Morris tool at week 1

    Baseline, week 1

  • Change from baseline in pain on the Brazilian Roland-Morris tool at week 12

    baseline, week 12

  • Change from baseline in pain on the visual analog scale (VAS) score for pain

    Baseline, week 12

Other Outcomes (1)

  • Adverse effects questionnaire

    Immediately after intervention and 3 months post application

Study Arms (3)

Lidocaine

EXPERIMENTAL

Paraspinal infusion of 3ml lidocaine at 1%, once a week for three weeks, combined with standard treatment.

Drug: LidocaineOther: Standard treatment

Sham lidocaine

SHAM COMPARATOR

Sham Injection, without lidocaine, combined with standard treatment.

Drug: Sham LidocaineOther: Standard treatment

Standard treatment only

ACTIVE COMPARATOR

The only intervention is the standard treatment. No lidocaine or shame injection was used.

Other: Standard treatment

Interventions

LidocaineDRUG

Paraspinal block with 3ml lidocaine injection at 1%.

Also known as: 3ml lidocaine 1% Injection
Lidocaine
Sham LidocaineDRUG

Sham injection, without lidocaine.

Also known as: 3ml sham injection
Sham lidocaine
Standard treatmentOTHER

Standard treatment only, without lidocaine or sham injection.

Also known as: Lowback pain standard treatment
LidocaineSham lidocaineStandard treatment only

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 to 60 years;
  • Clinical symptoms of vertebral pain that is unresponsive to symptomatic treatment with anti-inflammatory drugs for 3 months;
  • Moderate to severe pain: visual analog scale (VAS) \> 4;
  • Diagnosis of chronic nonspecific low back pain;
  • MiniMental test (MEEM) between 24 and 30;
  • Availability to comply with the visits;
  • Agree with signing the Informed Consent Form

You may not qualify if:

  • Severe psychiatric disease that requires psychiatric care;
  • Neurological disorders (lumbosciatic pain);
  • Concurrent fibromyalgia, per the 1990 diagnostic criteria of the American Academy of Rheumatology
  • Concurrent rheumatic disease
  • History of allergy to lidocaine (used for paraspinal blocks)
  • Labor problems
  • History of surgery on the lumbar spine
  • No availability to visit the clinic for treatment and evaluations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Imamura M, Imamura ST, Targino RA, Morales-Quezada L, Onoda Tomikawa LC, Onoda Tomikawa LG, Alfieri FM, Filippo TR, da Rocha ID, Neto RB, Fregni F, Battistella LR. Paraspinous Lidocaine Injection for Chronic Nonspecific Low Back Pain: A Randomized Controlled Clinical Trial. J Pain. 2016 May;17(5):569-76. doi: 10.1016/j.jpain.2016.01.469. Epub 2016 Jan 30.

    PMID: 26828801DERIVED

MeSH Terms

Interventions

LidocaineInjectionssalicylhydroxamic acid

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Marta Imamura, MD

    Instituto de Medicina Física e Reabilitação HCFMUSP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
1. Head of Technical Section of Physical and Rehabilitation Medicine of the Orthopedics and Traumatology Institute of HC FMUSP, Coordinator of the Center for Physical and Rehabilitation Medicine of HC FMUSP

Study Record Dates

First Submitted

May 22, 2014

First Posted

March 13, 2015

Study Start

January 1, 2007

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations

BR(1)