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Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder

This study has been withdrawn prior to enrollment.
(no participant recruited)
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 22, 2017
Last verified: August 2015
  Purpose
To determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury.

Condition Intervention Phase
Whiplash Injuries
Neck Pain
Procedure: Lidocaine
Other: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 Maggie Qiyun Shi, Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • pain [ Time Frame: 2 weeks following injection ]
    10 cm Visual Analog Scale


Secondary Outcome Measures:
  • cervical range of motion [ Time Frame: Immediately, 2 and 6 weeks after injection ]
  • self-report neck disability [ Time Frame: Immediately, 2 and 6 weeks after injection ]
  • globe perceived effects [ Time Frame: Immediately, 2 and 6 weeks after injection ]
    The Short Form-12

  • work performance [ Time Frame: Immediately, 2 and 6 weeks after injection ]
    questionnaire

  • pain [ Time Frame: 5 minutes following injection ]
    10 cm Visual Analog Scale

  • pain [ Time Frame: 6 weeks following injection ]
    10 cm Visual Analog Scale


Enrollment: 0
Study Start Date: October 2015
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: January 2016 (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).
Active Comparator: Saline
The control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis.
Other: Saline
The control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Canada, Ontario
Department of physical medicine and rehabilitation, McMaster University
Hamilton, Ontario, Canada, L8V 1C3
HHS (Juravinski Hospital Site)
Hamilton, Ontario, Canada, L8V 1C3
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Study Director: Joy MacDermid, Ph.D. McMaster University
  More Information

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 22, 2017
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on May 25, 2017