NCT02060734

Brief Summary

To determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 23, 2017

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

February 7, 2014

Last Update Submit

February 22, 2017

Conditions

Whiplash InjuriesNeck Pain

Keywords

Whiplash,injection,lidocaine,sham needling

Outcome Measures

Primary Outcomes (1)

  • pain

    10 cm Visual Analog Scale

    2 weeks following injection

Secondary Outcomes (6)

  • cervical range of motion

    Immediately, 2 and 6 weeks after injection

  • self-report neck disability

    Immediately, 2 and 6 weeks after injection

  • globe perceived effects

    Immediately, 2 and 6 weeks after injection

  • work performance

    Immediately, 2 and 6 weeks after injection

  • pain

    5 minutes following injection

  • +1 more secondary outcomes

Study Arms (2)

lidocaine

EXPERIMENTAL

The treatment group will receive a 25 gauge, 40mm long needle, pre-filled with 1% lidocaine inserting into the site of the trigger point. Three to five points injection.

Procedure: Lidocaine

Saline

ACTIVE COMPARATOR

The control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis.

Other: Saline

Interventions

LidocainePROCEDURE

Lidocaine injection 3-5 points in experimental group( using 25 gauge, 40mm long needle, pre-filled with 1% lidocaine inserting into the site of the trigger point).

lidocaine
SalineOTHER

The control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis.

Saline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fulfill the Grade II Quebec Task Force classification of WAD,
  • with identifiable myofascial trigger points ( which occur with or without a taut band),
  • reproduction of recognizable pain with sustained pressure ( up to 10 seconds) on trigger points
  • aged 18 to 70
  • a good understanding of informed consent and willing to attend this trial.

You may not qualify if:

  • have serious injury such as fracture and internal bleeding
  • suspicion of upper cervical instability or neurological deficits
  • clinical evidence of radiculopathy
  • a history of active cancer, central nerve disorder, blood clotting disorders, needle phobia
  • anticoagulant medication user
  • previous experience with any type of needling for myofascial pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of physical medicine and rehabilitation, McMaster University

Hamilton, Ontario, L8V 1C3, Canada

Location

HHS (Juravinski Hospital Site)

Hamilton, Ontario, L8V 1C3, Canada

Location

MeSH Terms

Conditions

Whiplash InjuriesNeck Pain

Interventions

LidocaineSodium Chloride

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Joy MacDermid, Ph.D.

    McMaster University

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate student, Western University

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 12, 2014

Study Start

October 1, 2015

Primary Completion

January 1, 2016

Study Completion

September 1, 2016

Last Updated

February 23, 2017

Record last verified: 2015-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)