Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Hamilton Health Sciences Corporation
Sponsor:
Information provided by (Responsible Party):
Maggie Qiyun Shi, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT02060734
First received: February 7, 2014
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Whiplash Injuries,
Neck Pain,
Procedure: Lidocaine
Device: Sham needling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated disorder-a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • pain [ Time Frame: 2 weeks following injection ] [ Designated as safety issue: No ]
    10 cm Visual Analog Scale


Secondary Outcome Measures:
  • cervical range of motion [ Time Frame: Immediately, 2 and 6 weeks after injection ] [ Designated as safety issue: No ]
  • self-report neck disability [ Time Frame: Immediately, 2 and 6 weeks after injection ] [ Designated as safety issue: No ]
  • globe perceived effects [ Time Frame: Immediately, 2 and 6 weeks after injection ] [ Designated as safety issue: No ]
    The Short Form-12

  • work performance [ Time Frame: Immediately, 2 and 6 weeks after injection ] [ Designated as safety issue: No ]
    questionnaire

  • pain [ Time Frame: 5 minutes following injection ] [ Designated as safety issue: No ]
    10 cm Visual Analog Scale

  • pain [ Time Frame: 6 weeks following injection ] [ Designated as safety issue: No ]
    10 cm Visual Analog Scale


Estimated Enrollment: 52
Study Start Date: March 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lidocaine
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
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).
Sham Comparator: Sham needling
Sham needle is a modification of the acupuncture needle. The tips of needles are blunted and applied to the skin over the trigger point without penetrating skin.
Device: Sham needling
Blunted acupuncture needle ( sham needle ) applies to trigger point without penetrating skin

Detailed Description:

This is a double-blind, randomized controlled trial to determine the efficacy of lidocaine injection of trigger points versus placebo 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060734

Contacts
Contact: David Harvey, MD 9055748515 dharvey@hhsc.ca

Locations
Canada, Ontario
HHS (Juravinski Hospital Site) Not yet recruiting
Hamilton, Ontario, Canada, L8V 1C3
Contact: David Harvey       dharvey@hhsc.ca   
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Study Director: Joy MacDermid, Ph.D. McMaster University
  More Information

No publications provided

Responsible Party: Maggie Qiyun Shi, Graduate student, Western University, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02060734     History of Changes
Other Study ID Numbers: HHSCTRIGGERINJ1402
Study First Received: February 7, 2014
Last Updated: February 10, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Hamilton Health Sciences Corporation:
Whiplash,
injection,
lidocaine,
sham needling

Additional relevant MeSH terms:
Whiplash Injuries
Neck Pain
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neck Injuries
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014