Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02060734

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Whiplash Injuries Neck Pain	Procedure: Lidocaine Other: Saline	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Sep 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

pain [2 weeks following injection]
10 cm Visual Analog Scale

Secondary Outcome Measures

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 [Immediately, 2 and 6 weeks after injection]
The Short Form-12
work performance [Immediately, 2 and 6 weeks after injection]
questionnaire
pain [5 minutes following injection]
10 cm Visual Analog Scale
pain [6 weeks following injection]
10 cm Visual Analog Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of physical medicine and rehabilitation, McMaster University	Hamilton	Ontario	Canada	L8V 1C3
2	HHS (Juravinski Hospital Site)	Hamilton	Ontario	Canada	L8V 1C3