Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder

NCT ID: NCT02060734

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Whiplash Injuries Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type PROCEDURE

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).

Saline

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

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type OTHER

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

Interventions

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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).

Intervention Type PROCEDURE

Saline

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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Maggie Qiyun Shi

Graduate student, Western University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joy MacDermid, Ph.D.

Role: STUDY_DIRECTOR

McMaster University

Locations

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Department of physical medicine and rehabilitation, McMaster University

Hamilton, Ontario, Canada

Site Status

HHS (Juravinski Hospital Site)

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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HHSCTRIGGERINJ1402

Identifier Type: -

Identifier Source: org_study_id

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