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Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder

Primary Purpose

Whiplash Injuries, Neck Pain

Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Lidocaine
Saline
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whiplash Injuries focused on measuring Whiplash,, injection,, lidocaine,, sham needling

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of physical medicine and rehabilitation, McMaster University
  • HHS (Juravinski Hospital Site)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lidocaine

Saline

Arm Description

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.

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

Outcomes

Primary Outcome Measures

pain
10 cm Visual Analog Scale

Secondary Outcome Measures

cervical range of motion
self-report neck disability
globe perceived effects
The Short Form-12
work performance
questionnaire
pain
10 cm Visual Analog Scale
pain
10 cm Visual Analog Scale

Full Information

First Posted
February 7, 2014
Last Updated
February 22, 2017
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02060734
Brief Title
Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder
Official Title
Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated disorder-a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
no participant recruited
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury.
Detailed Description
This is a double-blind, randomized controlled trial to determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury. Outcomes include pain, objective assessment, self-report function recovery, impact on work performance and globe perceived effects which will be assessed 5 minutes, 2 and 6 weeks following injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injuries, Neck Pain
Keywords
Whiplash,, injection,, lidocaine,, sham needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lidocaine
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
The control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis.
Intervention Type
Procedure
Intervention Name(s)
Lidocaine
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
The control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis.
Primary Outcome Measure Information:
Title
pain
Description
10 cm Visual Analog Scale
Time Frame
2 weeks following injection
Secondary Outcome Measure Information:
Title
cervical range of motion
Time Frame
Immediately, 2 and 6 weeks after injection
Title
self-report neck disability
Time Frame
Immediately, 2 and 6 weeks after injection
Title
globe perceived effects
Description
The Short Form-12
Time Frame
Immediately, 2 and 6 weeks after injection
Title
work performance
Description
questionnaire
Time Frame
Immediately, 2 and 6 weeks after injection
Title
pain
Description
10 cm Visual Analog Scale
Time Frame
5 minutes following injection
Title
pain
Description
10 cm Visual Analog Scale
Time Frame
6 weeks following injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy MacDermid, Ph.D.
Organizational Affiliation
McMaster University
Official's Role
Study Director
Facility Information:
Facility Name
Department of physical medicine and rehabilitation, McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
HHS (Juravinski Hospital Site)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder

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