Chronic Mechanical Neck PainNCT01772966
Chiropractic Manual Therapy and Neck Pain
A study testing Spinal manipulation in people with Chronic Mechanical Neck Pain, run by Canadian Memorial Chiropractic College at 1 site in Canada.
Trial summary
Eligible subjects with chronic neck pain will be randomly allocated to one of two intervention groups: real vs control spinal manipulation. They will receive three intervention sessions. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Chronic Mechanical Neck Pain
- What is being tested?
- Spinal manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Aug 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or Female
- 21 to 60 years of age
- Chronic neck pain
- Neck pain duration greater than 6 weeks
- Numeric Rating Scale greater than 30, less than 65
- Pain distribution between nuchal ridge and spine of the scapula
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- Pain aggravated by local provocation maneuvers at single motion segment
- Antero-posterior glide
- Paraspinal tenderness
- Negative provocative maneuvers at adjacent segment
- Able to tolerate neck movement to 50 percent normal in all directions
Who cannot join
- Worker's compensation or other medico-legal claim
- Cervical spine surgery or fracture or dislocation
- Uncontrolled hypertension (Blood Pressure over 140 over 90)
- Stroke or Transient Ischemic Attack
- Upper respiratory infection within 4 weeks
- Severe degenerative disease of the cervical spine
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- New or significantly altered pattern of headache complaint
- Connective tissue disease
- Primary fibromyalgia
- Metabolic or metaplastic bone disease
- Whiplash injury within 12 months
- High cholesterol levels not well-managed medically
- Cardiovascular surgery in the past 6 months or planned
- Use of narcotic analgesic, prescription anti-inflammatory, or muscle relaxants, anti-convulsants
- Angina pectoris
- Dizziness
- Tinnitus
- Blurred vision, vertigo, undiagnosed sensory and motor disturbances
- Radicular symptoms and signs
- Current use of anticoagulant therapy
- Upper respiratory infection
- Neck pain on provocation greater than 7 out of 10
- Provocation of radicular pain or sensory disturbance
- Hypermobility of multiple peripheral joints,
- Physical or mental impairment precluding following instructions or participating -in supine recumbent postures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain
Eligible subjects with chronic neck pain will be randomly allocated to one of two intervention groups: real vs control spinal manipulation. They will receive three intervention sessions.
H1: Chronic neck pain patients treated longitudinally over a series of three encounters in one week by random assignment to treatment group with either of the dual delivery procedures (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error rate of self-report of group allocation at exit interview.
Read more
H2: Patients treated by the typical-control dual procedure over a typical sequence of encounters (3 times in one week) will show statistically significant improvement in clinical outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index (NDI), range of motion and pressure algometry; compared to those treated by the control-control dual procedure.
H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no significant difference in self-report of group allocation or clinical outcome measures.
A total of 372 subjects will be recruited.
- Conditions
- Chronic Mechanical Neck Pain
- Being tested
- Spinal manipulation
- Keywords
- neck, pain, chronic, manipulation, control, randomized trial
- Medical subject headings
- Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal manipulationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Spinal manipulation | Experimental | Participants will receive spinal manipulation delivered as segmental thrust to a specific site in the neck. They will receive three intervention sessions over 7-10 days. Receives: Procedure: Spinal manipulation |
| Control manipulation | Sham comparator | Participants will receive spinal manipulation delivered as non-segmental thrust to the neck. They will receive three intervention sessions over 7-10 days. Receives: Procedure: Spinal manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group registration
Participants will be asked to identify which of the two interventions they feel they received.
Measured: At exit assessment following the third intervention session
Secondary outcomes (4)
Pain severity
Pain scores on the PROMIS pain severity instrument.
Measured: 1. at baseline, and 2. At exit assessment following the third intervention session
Improvement
Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument.
Measured: At exit assessment following the third intervention session
Disability
Participants will score the The Neck Disability Index (score out of 50).
Measured: 1. at baseline, and 2. At exit assessment following the third intervention session
Tenderness
Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm.
Measured: 1. at baseline, and 2. At exit assessment following the third intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Mechanical Neck PainStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Memorial Chiropractic College
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Howard T Vernon, DC, PhD, Principal investigator, Canadian Memorial Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772966
- Sponsor's protocol ID
- 122008
- Other IDs
- R01AT007311-01
- Status last verified
- Oct 2016
- First submitted
- 21 Sep 2012
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vernon H, MacAdam K, Marshall V, Pion M, Sadowska M. Validation of a sham manipulative procedure for the cervical spine for use in clinical trials. J Manipulative Physiol Ther. 2005 Nov-Dec;28(9):662-6. doi: 10.1016/j.jmpt.2005.07.020.
PubMed 16326235
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT01772966
- Acronym / sponsor ID
- 122008
- Conditions
- Chronic Mechanical Neck Pain
- Keywords
- neck, pain, chronic, manipulation, control, randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Canadian Memorial Chiropractic CollegeUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Feb 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Jan 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.
Eligible subjects with chronic neck pain will be randomly allocated to one of two intervention groups: real vs control spinal manipulation. They will receive three intervention sessions.
H1: Chronic neck pain patients treated longitudinally over a series of three encounters in one week by random assignment to treatment group with either of the dual delivery procedures (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error rate of self-report of group allocation at exit interview.
H2: Patients treated by the typical-control dual procedure over a typical sequence of encounters (3 times in one week) will show statistically significant improvement in clinical outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index (NDI), range of motion and pressure algometry; compared to those treated by the control-control dual procedure.
H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no significant difference in self-report of group allocation or clinical outcome measures.
A total of 372 subjects will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal manipulation | Experimental | Procedure: Spinal manipulationParticipants will receive spinal manipulation delivered as segmental thrust to a specific site in the neck. They will receive three intervention sessions over 7-10 days. |
| Control manipulation | Sham comparator | Procedure: Spinal manipulationParticipants will receive spinal manipulation delivered as non-segmental thrust to the neck. They will receive three intervention sessions over 7-10 days. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or Female
- 21 to 60 years of age
- Chronic neck pain
- Neck pain duration greater than 6 weeks
- Numeric Rating Scale greater than 30, less than 65
Key exclusion criteria (25 listed)
- Worker's compensation or other medico-legal claim
- Cervical spine surgery or fracture or dislocation
- Uncontrolled hypertension (Blood Pressure over 140 over 90)
- Stroke or Transient Ischemic Attack
- Upper respiratory infection within 4 weeks
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 |
|---|---|---|
| Spinal manipulation | Procedure or surgery | Control manipulation, Spinal manipulation |
Primary outcome
Group registration
Time frame: At exit assessment following the third intervention session
Participants will be asked to identify which of the two interventions they feel they received.
4 secondary outcomes
Pain severity
Time frame: 1. at baseline, and 2. At exit assessment following the third intervention session
Improvement
Time frame: At exit assessment following the third intervention session
Disability
Time frame: 1. at baseline, and 2. At exit assessment following the third intervention session
Tenderness
Time frame: 1. at baseline, and 2. At exit assessment following the third intervention session
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 31 Oct 2016.
- Results publication: PubMed 16326235Vernon H, MacAdam K, Marshall V, Pion M, Sadowska M. Validation of a sham manipulative procedure for the cervical spine for use in clinical trials. J Manipulative Physiol Ther. 2005 Nov-Dec;28(9):662-6. doi: 10.1016/j.jmpt.2005.07.020.
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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.
Howard T Vernon, DC, PhD principal investigator
Canadian Memorial Chiropractic College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal manipulation in people with Chronic Mechanical Neck Pain, run by Canadian Memorial Chiropractic College 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 11 inclusion and 25 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 31 Oct 2016. 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. Some participants in this study may receive a placebo. 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?
Group registration (time frame: At exit assessment following the third intervention session). 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 NCT01772966, which also lists 1 linked publication.
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 31 Oct 2016; AzTrials last refreshed its copy on 31 Oct 2026.