Whiplash InjuriesPhase 2/3NCT00560807
Manual Therapy Dosage Factorial Study
A Phase 2/3 study testing Mobilization in people with Whiplash Injuries, run by McMaster University at 1 site in Canada.
Trial summary
This study will determine biological responses to different dosages of neck mobilization intervention in patients, providing opportunities to identify the optimal dosage, predictors of response, outcome measures as well as the longitudinal changes in biology. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Whiplash Injuries
- What is being tested?
- Mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days or subacute (30 to 90 days)
- pain in the neck but may radiate to the shoulder region or upper extremities or have an associated headache
- pain intensity must be at or above 30 mm on a 100 mm visual analogue scale
- must be a new episode of pain with ,no other occurrences of neck pain requiring treatment in the previous 4 months.
Who cannot join
- arthritis, neurological diseases, fractures, dislocation, rheumatoid arthritis, long tract signs and malignancy
- conditions that make the provision of neck exercise unsafe
Trial locations and contacts
1 site in 1 country.
About this study
This study will determine biological responses to different dosages of neck mobilization intervention in patients, providing opportunities to identify the optimal dosage, predictors of response, outcome measures as well as the longitudinal changes in biology.
Subjects with acute whiplash associated disorders (WAD) II and III with a symptom duration of less than 30 days (acute) or 30 to 90 days (subacute) will be randomly assigned to receive different doses of mobilization. The dosage treatment groups will differ in the number of sessions (1, 2 or 3 times per week) and the duration of treatment (duration of treatment intervention will be 3, 6, or 12 weeks). A zero treatment/week option is included to insure that the impact of any mobilization is included and because previous studies suggest a single mobilization may have a treatment effect.
Read more
All patient participants will receive a core standard treatment of education, advice to stay active, and neck/postural stretching and strengthening exercise. All patient participants will receive supervised exercise and advice for the full 12 weeks. All patients will be provided with an instructional CD and exercise brochure to reinforce the whole program.
Follow-up assessments will consist of quantitative sensory testing (vibration threshold; current perception threshold), the Neck Walk Index (NWI), the Upper Cyclical Reach and Grasp Task, muscle biology analyses (cytokine analyses), central breathing control tests (capnography), range of motion, head flexion endurance, and self-report symptoms and disability (Visual Analogue Scale; Neck Disability Index; Disabilities of the Arm, Shoulder, Hand; pain threshold and tolerance algometry; and perceived self-efficacy; SF-36).
Hypothesis: During recovery, patient are expected to transition from an acute painful state to one where they can resume normal activity and add intensive strengthening exercises.
- Conditions
- Whiplash Injuries
- Being tested
- Mobilization
- Keywords
- WAD II, WAD III, mobilization, dosage, acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days, neck pain
- Medical subject headings
- Whiplash Injuries, Weyers acrofacial dysostosis, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobilizationProcedure or surgery
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Zero treatment/3 weeks |
| B | Active comparator | Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks Receives: Procedure: Mobilization |
| C | Active comparator | Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks Receives: Procedure: Mobilization |
| D | Active comparator | Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks Receives: Procedure: Mobilization |
| F | Active comparator | Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks Receives: Procedure: Mobilization |
| G | Active comparator | Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks Receives: Procedure: Mobilization |
| H | Active comparator | Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks Receives: Procedure: Mobilization |
| J | Active comparator | Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks Receives: Procedure: Mobilization |
| K | Active comparator | Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks Receives: Procedure: Mobilization |
| L | Active comparator | Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks Receives: Procedure: Mobilization |
| E | No intervention | Zero treatment/6 weeks |
| I | No intervention | Zero treatment/12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Sensory Testing (QST)
Measured: Within 24 weeks
Current Perception Threshold (CPT)
Measured: Within 24 weeks
Neck Walk Index (NWI)
Measured: Within 24 weeks
Cyclical Reach and Grasp Test (CRGT)
Measured: Within 24 weeks
Muscle Biology (cytokine analyses)
Measured: Within 24 weeks
Central Breathing Control Test
Measured: Within 24 weeks
Neck Disability Index
Measured: Within 24 weeks
Pain Intensity - Visual Analogue Scale (VAS)
Measured: Within 24 weeks
Secondary outcomes (6)
Global Perceived Effect (GPE)
Measured: Within 24 weeks
Disabilities of the Arm, Shoulder, and Hand (DASH)
Measured: Within 24 weeks
Pain Threshold and Pain Tolerance Algometry
Measured: Within 24 weeks
Head Flexion Endurance
Measured: Within 24 weeks
Range of Motion
Measured: Within 24 weeks
Quality of Life (SF-36v2)
Measured: within 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
Why it stopped: The study was stopped because the study never received funding
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), National Institutes of Health (NIH), University of Western Ontario, Canada
- Investigators
- Joy C MacDermid, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560807
- Sponsor's protocol ID
- 1 R21 AT004263
- Status last verified
- Sep 2015
- First submitted
- 19 Nov 2007
- Last updated
- 23 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy Dosage Factorial Study
- ClinicalTrials.gov ID
- NCT00560807
- Acronym / sponsor ID
- 1 R21 AT004263
- Conditions
- Whiplash Injuries
- Keywords
- WAD II, WAD III, mobilization, dosage, acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days, neck pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped because the study never received funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), National Institutes of Health (NIH), University of Western Ontario, Canada
- First posted
- 20 Nov 2007 (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.
This study will determine biological responses to different dosages of neck mobilization intervention in patients, providing opportunities to identify the optimal dosage, predictors of response, outcome measures as well as the longitudinal changes in biology.
Subjects with acute whiplash associated disorders (WAD) II and III with a symptom duration of less than 30 days (acute) or 30 to 90 days (subacute) will be randomly assigned to receive different doses of mobilization. The dosage treatment groups will differ in the number of sessions (1, 2 or 3 times per week) and the duration of treatment (duration of treatment intervention will be 3, 6, or 12 weeks). A zero treatment/week option is included to insure that the impact of any mobilization is included and because previous studies suggest a single mobilization may have a treatment effect.
All patient participants will receive a core standard treatment of education, advice to stay active, and neck/postural stretching and strengthening exercise. All patient participants will receive supervised exercise and advice for the full 12 weeks. All patients will be provided with an instructional CD and exercise brochure to reinforce the whole program.
Follow-up assessments will consist of quantitative sensory testing (vibration threshold; current perception threshold), the Neck Walk Index (NWI), the Upper Cyclical Reach and Grasp Task, muscle biology analyses (cytokine analyses), central breathing control tests (capnography), range of motion, head flexion endurance, and self-report symptoms and disability (Visual Analogue Scale; Neck Disability Index; Disabilities of the Arm, Shoulder, Hand; pain threshold and tolerance algometry; and perceived self-efficacy; SF-36).
Hypothesis: During recovery, patient are expected to transition from an acute painful state to one where they can resume normal activity and add intensive strengthening exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Zero treatment/3 weeks |
| B | Active comparator | Procedure: MobilizationFrequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks |
| C | Active comparator | Procedure: MobilizationFrequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks |
| D | Active comparator | Procedure: MobilizationFrequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks |
| F | Active comparator | Procedure: MobilizationFrequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks |
| G | Active comparator | Procedure: MobilizationFrequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks |
| H | Active comparator | Procedure: MobilizationFrequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks |
| J | Active comparator | Procedure: MobilizationFrequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks |
| K | Active comparator | Procedure: MobilizationFrequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks |
| L | Active comparator | Procedure: MobilizationFrequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks |
| E | No intervention | –Zero treatment/6 weeks |
| I | No intervention | –Zero treatment/12 weeks |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days or subacute (30 to 90 days)
- pain in the neck but may radiate to the shoulder region or upper extremities or have an associated headache
- pain intensity must be at or above 30 mm on a 100 mm visual analogue scale
- must be a new episode of pain with ,no other occurrences of neck pain requiring treatment in the previous 4 months.
Key exclusion criteria (2 listed)
- arthritis, neurological diseases, fractures, dislocation, rheumatoid arthritis, long tract signs and malignancy
- conditions that make the provision of neck exercise unsafe
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 |
|---|---|---|
| MobilizationMobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range. | Procedure or surgery | B, C, D, F, G, H, J, K, L |
Primary outcome
Quantitative Sensory Testing (QST)
Time frame: Within 24 weeks
Current Perception Threshold (CPT)
Time frame: Within 24 weeks
Neck Walk Index (NWI)
Time frame: Within 24 weeks
Cyclical Reach and Grasp Test (CRGT)
Time frame: Within 24 weeks
Muscle Biology (cytokine analyses)
Time frame: Within 24 weeks
Central Breathing Control Test
Time frame: Within 24 weeks
Neck Disability Index
Time frame: Within 24 weeks
Pain Intensity - Visual Analogue Scale (VAS)
Time frame: Within 24 weeks
6 secondary outcomes
Global Perceived Effect (GPE)
Time frame: Within 24 weeks
Disabilities of the Arm, Shoulder, and Hand (DASH)
Time frame: Within 24 weeks
Pain Threshold and Pain Tolerance Algometry
Time frame: Within 24 weeks
Head Flexion Endurance
Time frame: Within 24 weeks
Range of Motion
Time frame: Within 24 weeks
Quality of Life (SF-36v2)
Time frame: within 24 weeks
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 Sep 2015.
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 C MacDermid, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mobilization in people with Whiplash Injuries, run by McMaster University at 1 site 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 4 inclusion and 2 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 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Quantitative Sensory Testing (QST) (time frame: Within 24 weeks). The study lists 8 primary outcomes in all. 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 Sep 2015.