Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder

Neck Pain Clinical Trial

Official title:

Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated disorder-a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02060734
• Other study ID #: HHSCTRIGGERINJ1402
• Status: Withdrawn
• Phase: Phase 4
• First received: February 7, 2014
• Last updated: February 22, 2017
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2015
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain
• Whiplash Injuries

Intervention

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).

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

Locations

Country	Name	City	State
Canada	Department of physical medicine and rehabilitation, McMaster University	Hamilton	Ontario
Canada	HHS (Juravinski Hospital Site)	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	10 cm Visual Analog Scale	2 weeks following injection
Secondary	cervical range of motion		Immediately, 2 and 6 weeks after injection
Secondary	self-report neck disability		Immediately, 2 and 6 weeks after injection
Secondary	globe perceived effects	The Short Form-12	Immediately, 2 and 6 weeks after injection
Secondary	work performance	questionnaire	Immediately, 2 and 6 weeks after injection
Secondary	pain	10 cm Visual Analog Scale	5 minutes following injection
Secondary	pain	10 cm Visual Analog Scale	6 weeks following injection