Whiplash InjuriesPhase 4NCT02060734
Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder
A Phase 4 study testing Lidocaine and Saline in people with Whiplash Injuries and Neck Pain, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
To determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Whiplash Injuries, Neck Pain
- What is being tested?
- Lidocaine and Saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2015to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Department of physical medicine and rehabilitation, McMaster University
Hamilton, Ontario, L8V 1C3
HHS (Juravinski Hospital Site)
Hamilton, Ontario, L8V 1C3
About this study
Official title: 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.
Read the 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.
- Conditions
- Whiplash Injuries, Neck Pain
- Being tested
- Lidocaine, Saline
- Keywords
- Whiplash,, injection,, lidocaine,, sham needling
- Medical subject headings
- Whiplash Injuries, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineProcedure or surgery
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).
SalineOther
The control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis.
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Experimental | 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. Receives: Procedure: Lidocaine |
| Saline | Active comparator | The control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
10 cm Visual Analog Scale
Measured: 2 weeks following injection
Secondary outcomes (6)
cervical range of motion
Measured: Immediately, 2 and 6 weeks after injection
self-report neck disability
Measured: Immediately, 2 and 6 weeks after injection
globe perceived effects
The Short Form-12
Measured: Immediately, 2 and 6 weeks after injection
work performance
questionnaire
Measured: Immediately, 2 and 6 weeks after injection
pain
10 cm Visual Analog Scale
Measured: 5 minutes following injection
pain
10 cm Visual Analog Scale
Measured: 6 weeks following injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startOct 2015
- Primary completionJan 2016 (estimated)
- Study completionSep 2016 (estimated)
Why it stopped: no participant recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maggie Qiyun Shi, Hamilton Health Sciences Corporation
- Investigators
- Joy MacDermid, Ph.D., Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060734
- Sponsor's protocol ID
- HHSCTRIGGERINJ1402
- Status last verified
- Aug 2015
- First submitted
- 7 Feb 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated disorder-a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02060734
- Acronym / sponsor ID
- HHSCTRIGGERINJ1402
- Conditions
- Whiplash Injuries, Neck Pain
- Keywords
- Whiplash,, injection,, lidocaine,, sham needling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participant recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Experimental | Procedure: LidocaineThe 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. |
| Saline | Active comparator | Other: SalineThe control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineLidocaine 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). | Procedure or surgery | lidocaine |
| SalineThe control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis. | Other | Saline |
Primary outcome
pain
Time frame: 2 weeks following injection
10 cm Visual Analog Scale
6 secondary outcomes
cervical range of motion
Time frame: Immediately, 2 and 6 weeks after injection
self-report neck disability
Time frame: Immediately, 2 and 6 weeks after injection
globe perceived effects
Time frame: Immediately, 2 and 6 weeks after injection
work performance
Time frame: Immediately, 2 and 6 weeks after injection
pain
Time frame: 5 minutes following injection
pain
Time frame: 6 weeks following injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Whiplash Injuries
Active, not recruiting
Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.
Whiplash-associated Disorders
Not yet recruiting
StressModex for Post-Traumatic Neck Pain
Post-Traumatic Neck Pain, Whiplash-associated Disorders
Recruiting
Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
Whiplash Associated Disorder (WAD)
Recruiting
Virtual Reality Rehabilitation in Neck Pain Subjects
Neck Pain, Chronic Pain
Not yet recruiting
Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome
Whiplash Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy MacDermid, Ph.D. study director
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and Saline in people with Whiplash Injuries and Neck Pain, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 2 weeks following injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.