Whiplash InjuriesNCT01957033

Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study

A study testing Exercise and education once/week for 6 weeks, Exercise and education twice/week for 6 weeks and Exercise and education 3 times/week for 6 weeks in people with Whiplash Injuries, run by Jordan Miller, Graduate Student at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Whiplash Injuries
What is being tested?: Exercise and education once/week for 6 weeks, Exercise and education twice/week for 6 weeks and Exercise and education 3 times/week for 6 weeks
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 3 sitesCanada
Study dates: Oct 2013to Sep 2016
Phase: Interventional
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adults ≥ 21 years
main complaint must be neck pain, but we expect some patients will also report symptoms that radiate to the shoulder and arm regions or have an associated headache.
pain intensity must be ≥ 12/40 on the 4-item pain scale (P4).

Who cannot join

non-mechanical sources of neck pain or over-riding comorbidity listed below:
rheumatoid arthritis
neurological diseases
fractures
dislocation
rheumatoid arthritis

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upper motor neuron dysfunction or malignancy
pregnant women
closed head injury
on steroid-based medications within the past 6 months.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

McMaster Univervisty
Hamilton, Ontario, L8S 1C7
Lifemark Health, Hamilton
Hamilton, Ontario, L8S 4P9
Western University
London, Ontario, N6A 4L6

Other trials in Canada

About this study

Official title: Clinical and Biological Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study

The purpose of this pilot project is to determine the feasibility of a study design to investigate how many sessions of manual therapy and exercise produce the best results for people with whiplash injuries. Also, this study will help us determine the best way to measure the effect of treatment. Finally, the investigators will study how closely the physiotherapists follow the treatment instruction provided in the study protocol and training. In order to achieve these objectives, 12 people will receive manual therapy and exercise at one of twelve different doses. the investigators will have each of these people fill out questionnaires, measure sensation changes, and measure changes in the way people move their necks while walking. This study will help us determine if the study protocol can be carried out as planned. This includes: the training of all people involved in carrying out the assessments and treatments, the willingness and ability of participants to take part in all of the treatment and measures involved. This will provide us with important information to help us plan a larger study with 226 people with whiplash injuries.

Conditions: Whiplash Injuries
Being tested: Exercise and education once/week for 6 weeks, Exercise and education twice/week for 6 weeks, Exercise and education 3 times/week for 6 weeks, Manual therapy once/week for 3 weeks, Manual therapy twice/week for 3 weeks
Keywords: whiplash, neck pain, manual therapy, exercise, dosage
Medical subject headings: Whiplash Injuries, Neck Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exercise and education once/week for 6 weeksBehavioural
Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book
Exercise and education twice/week for 6 weeksBehavioural
Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.
Exercise and education 3 times/week for 6 weeksBehavioural
Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.
Manual therapy once/week for 3 weeksOther
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Manual therapy twice/week for 3 weeksOther
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Manual therapy 3 times/week for 3 weeksOther
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Manual therapy once/week for 6 weeksOther
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Manual therapy twice/week for 6 weeksOther
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Manual therapy 3 times/week for 6 weeksOther
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Study groups in NCT01957033
Study group	Role	What they receive
Duration 6 weeks, frequency 3/week	Experimental	Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for 6 weeks Receives: Behavioral: Exercise and education 3 times/week for 6 weeks; Other: Manual therapy 3 times/week for 6 weeks
Duration 6 weeks, Frequency twice/week	Experimental	Exercise and education twice/week for 6 weeks Manual therapy twice/week for 6 weeks Receives: Behavioral: Exercise and education twice/week for 6 weeks; Other: Manual therapy twice/week for 6 weeks
Duration 6 weeks, Frequency once/week	Experimental	Exercise and education once/week for 6 weeks Manual therapy once/week for first 6 weeks Receives: Behavioral: Exercise and education once/week for 6 weeks; Other: Manual therapy once/week for 6 weeks
Duration 3 weeks, Frequency 3 times/week	Experimental	Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for first 3 weeks Receives: Behavioral: Exercise and education 3 times/week for 6 weeks; Other: Manual therapy 3 times/week for 3 weeks
Duration 3 weeks, Frequency twice/week	Experimental	Exercise and education twice/week for 6 weeks Manual therapy twice/week for first 3 weeks Receives: Behavioral: Exercise and education twice/week for 6 weeks; Other: Manual therapy twice/week for 3 weeks
Duration 3 weeks, frequency once/week	Experimental	Exercise and education once/week for 6 weeks Manual therapy once/week for first 3 weeks Receives: Behavioral: Exercise and education once/week for 6 weeks; Other: Manual therapy once/week for 3 weeks
Duration 0 weeks, Frequency 3 times/week	Experimental	Exercise and education 3 times/week for 6 weeks No manual therapy Receives: Behavioral: Exercise and education 3 times/week for 6 weeks
Duration 0 weeks, Frequency twice/week	Experimental	Exercise and education twice/week for 6 weeks. No manual therapy Receives: Behavioral: Exercise and education twice/week for 6 weeks
Duration 0 weeks, Frequency once/week	Experimental	Exercise and education once/week for 6 weeks No manual therapy Receives: Behavioral: Exercise and education once/week for 6 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility
As a pilot study, the main outcome of interest is feasibility. This includes: ability to train assessors and health care providers, time it takes to complete all assessments, ability to recruit 12 patients within 1 year, and completeness of data collected.
Measured: 1 year
Pain
Measured by the 4-item pain questionnaire (P4). This will be a primary outcome of the full trial.
Measured: 12 weeks (end of treatment) and 6- and 12- month follow-ups
Function
Measured by the Neck Disability Index (NDI). This will be a primary outcome measure of the full powered study.
Measured: 12 weeks (end of treatment) and 6- and 12- month follow-up

Secondary outcomes (7)

Fidelity
As a pilot study, the secondary outcome of interest is treatment fidelity. We will measure this through ability of health care providers to provide treatment at the dosage described in the protocol.
Measured: 1 year
Psychological measures
Catastrophic thinking measured by Pain Catastrophizing Scale (PCS) Anxiety and Depression measured by Hospital Anxiety and Depression Scale (HADS) Psychological distress measured by Trauma Anxiety and Distress Scale (TADS)
Measured: 12 weeks (end of treatment)
Psychophysical measures
Vibration Pain Threshold (VPT), Current Perception Threshold (CPT), Pressure Pain Threshold (PPT), Response to Cold Provocation(RCP)
Measured: 12 weeks (end of treatment)
Motor coordination
Neck Walk Index (NWI)
Measured: 12 weeks (end of treatment)
Health Status
Measured by SF-36
Measured: 12 weeks (end of study) and 6- and 12- month follow-ups
Global perceived effect
Global perceived effect will be measured on a 7 point scale (-3 to +3)
Measured: 12 weeks (end of treatment) and 6- and 12-month follow-ups
Upper extremity function
As measured by the shortened version of the Disability of the Arm, Shoulder, Hand (qDASH).
Measured: 12 weeks (end of treatment) and 6- and 12-month follow-ups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Sep 2016

First posted8 Oct 2013 (estimated)
Study startOct 2013
Primary completionAug 2015
Study completionSep 2016

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01957033
Sponsor's protocol ID: 13-569
Status last verified: Sep 2016
First submitted: 29 Sep 2013
Last updated: 14 Sep 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Whiplash Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical and Biological Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study
ClinicalTrials.gov ID: NCT01957033
Acronym / sponsor ID: 13-569
Conditions: Whiplash Injuries
Keywords: whiplash, neck pain, manual therapy, exercise, dosage
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Jordan Miller, Graduate StudentUniversity, hospital or other
Collaborators: Physiotherapy Foundation of Canada
Study start: Oct 2013
Primary completion: Aug 2015 (actual)
Study completion: Sep 2016 (actual)
First posted: 8 Oct 2013 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 9

Arm	Type	Receives
Duration 6 weeks, frequency 3/week	Experimental	Behavioral: Exercise and education 3 times/week for 6 weeks, Other: Manual therapy 3 times/week for 6 weeksExercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for 6 weeks
Duration 6 weeks, Frequency twice/week	Experimental	Behavioral: Exercise and education twice/week for 6 weeks, Other: Manual therapy twice/week for 6 weeksExercise and education twice/week for 6 weeks Manual therapy twice/week for 6 weeks
Duration 6 weeks, Frequency once/week	Experimental	Behavioral: Exercise and education once/week for 6 weeks, Other: Manual therapy once/week for 6 weeksExercise and education once/week for 6 weeks Manual therapy once/week for first 6 weeks
Duration 3 weeks, Frequency 3 times/week	Experimental	Behavioral: Exercise and education 3 times/week for 6 weeks, Other: Manual therapy 3 times/week for 3 weeksExercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for first 3 weeks
Duration 3 weeks, Frequency twice/week	Experimental	Behavioral: Exercise and education twice/week for 6 weeks, Other: Manual therapy twice/week for 3 weeksExercise and education twice/week for 6 weeks Manual therapy twice/week for first 3 weeks
Duration 3 weeks, frequency once/week	Experimental	Behavioral: Exercise and education once/week for 6 weeks, Other: Manual therapy once/week for 3 weeksExercise and education once/week for 6 weeks Manual therapy once/week for first 3 weeks
Duration 0 weeks, Frequency 3 times/week	Experimental	Behavioral: Exercise and education 3 times/week for 6 weeksExercise and education 3 times/week for 6 weeks No manual therapy
Duration 0 weeks, Frequency twice/week	Experimental	Behavioral: Exercise and education twice/week for 6 weeksExercise and education twice/week for 6 weeks. No manual therapy
Duration 0 weeks, Frequency once/week	Experimental	Behavioral: Exercise and education once/week for 6 weeksExercise and education once/week for 6 weeks No manual therapy

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

adults ≥ 21 years
main complaint must be neck pain, but we expect some patients will also report symptoms that radiate to the shoulder and arm regions or have an associated headache.
pain intensity must be ≥ 12/40 on the 4-item pain scale (P4).

Key exclusion criteria (10 listed)

non-mechanical sources of neck pain or over-riding comorbidity listed below:
rheumatoid arthritis
neurological diseases
fractures
dislocation

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
Exercise and education once/week for 6 weeksExercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book	Behavioural	Duration 0 weeks, Frequency once/week, Duration 3 weeks, frequency once/week, Duration 6 weeks, Frequency once/week
Exercise and education twice/week for 6 weeksExercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.	Behavioural	Duration 0 weeks, Frequency twice/week, Duration 3 weeks, Frequency twice/week, Duration 6 weeks, Frequency twice/week
Exercise and education 3 times/week for 6 weeksExercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.	Behavioural	Duration 0 weeks, Frequency 3 times/week, Duration 3 weeks, Frequency 3 times/week, Duration 6 weeks, frequency 3/week
Manual therapy once/week for 3 weeksManual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.	Other	Duration 3 weeks, frequency once/week
Manual therapy twice/week for 3 weeksManual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.	Other	Duration 3 weeks, Frequency twice/week
Manual therapy 3 times/week for 3 weeksManual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.	Other	Duration 3 weeks, Frequency 3 times/week
Manual therapy once/week for 6 weeksManual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.	Other	Duration 6 weeks, Frequency once/week
Manual therapy twice/week for 6 weeksManual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.	Other	Duration 6 weeks, Frequency twice/week
Manual therapy 3 times/week for 6 weeksManual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.	Other	Duration 6 weeks, frequency 3/week

Primary outcome

Feasibility
Time frame: 1 year
As a pilot study, the main outcome of interest is feasibility. This includes: ability to train assessors and health care providers, time it takes to complete all assessments, ability to recruit 12 patients within 1 year, and completeness of data collected.
Pain
Time frame: 12 weeks (end of treatment) and 6- and 12- month follow-ups
Measured by the 4-item pain questionnaire (P4). This will be a primary outcome of the full trial.
Function
Time frame: 12 weeks (end of treatment) and 6- and 12- month follow-up
Measured by the Neck Disability Index (NDI). This will be a primary outcome measure of the full powered study.

7 secondary outcomes

Fidelity
Time frame: 1 year
Psychological measures
Time frame: 12 weeks (end of treatment)
Psychophysical measures
Time frame: 12 weeks (end of treatment)
Motor coordination
Time frame: 12 weeks (end of treatment)
Health Status
Time frame: 12 weeks (end of study) and 6- and 12- month follow-ups
Global perceived effect
Time frame: 12 weeks (end of treatment) and 6- and 12-month follow-ups
Upper extremity function
Time frame: 12 weeks (end of treatment) and 6- and 12-month follow-ups

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.

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.

Jordan D Miller, MSc principal investigator

McMaster University

Joy C MacDermid, PhD principal investigator

McMaster University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 10 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: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Feasibility (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01957033.

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 14 Sep 2016.