Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder

Phase 4

Withdrawn

• Conditions: Whiplash Injuries; Neck Pain
• Interventions: Other: Saline; Procedure: Lidocaine

• Registration Number: NCT02060734
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Study Timeline

• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-12
• Status Verified: 2015-08
• Study Start: 2015-10
• Primary Completion: 2016-01
• Study Completion: 2016-09
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
pain	2 weeks following injection	10 cm Visual Analog Scale

Secondary Outcome Measures

Name	Time	Method
work performance	Immediately, 2 and 6 weeks after injection	questionnaire
pain	6 weeks following injection	10 cm Visual Analog Scale
globe perceived effects	Immediately, 2 and 6 weeks after injection	The Short Form-12
cervical range of motion	Immediately, 2 and 6 weeks after injection
self-report neck disability	Immediately, 2 and 6 weeks after injection

Trial Locations

Locations (2)

Department of physical medicine and rehabilitation, McMaster University; 🇨🇦 Hamilton, Ontario, Canada

HHS (Juravinski Hospital Site); 🇨🇦 Hamilton, Ontario, Canada