Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder

Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated disorder-a 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.

Study Overview

• Status: Withdrawn
• Conditions: Neck Pain; Whiplash Injuries
• Intervention / Treatment: Procedure: Lidocaine; Other: Saline

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Department of physical medicine and rehabilitation, McMaster University
    • Hamilton, Ontario, Canada, L8V 1C3
      • HHS (Juravinski Hospital Site)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	10 cm Visual Analog Scale	2 weeks following injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The Short Form-12	Immediately, 2 and 6 weeks after injection
work performance	questionnaire	Immediately, 2 and 6 weeks after injection
pain	10 cm Visual Analog Scale	5 minutes following injection
pain	10 cm Visual Analog Scale	6 weeks following injection

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Study Director: Joy MacDermid, Ph.D., McMaster University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: February 10, 2014
• First Posted (Estimate): February 12, 2014

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: lidocaine,; Whiplash,; injection,; sham needling
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Neck Injuries; Neck Pain; Whiplash Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: HHSCTRIGGERINJ1402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO