Chronic Neck PainNCT00978094
Validation of a Novel Sham Cervical Spinal Manipulation Procedure
An observational study of Chronic Neck Pain, run by Canadian Memorial Chiropractic College at 1 site in Canada.
Trial summary
Primary hypotheses: Ho1: In chronic neck pain patients, randomly treated with either a "sham" or "real" cervical manipulation procedure, the probability of perceiving a Real Manipulation Procedure is equal to the probability of obtaining a Real Manipulation Procedure, AND, Ho2: Spinal tenderness will remain unchanged… Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Chronic Neck Pain
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Oct 2010
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants in this study will be consenting adults, 21-55 years of age, male or female who have chronic mechanical neck pain (NP) rated as between 30 and 65 on an NRS-101 scale [74]. For the purposes of this study NP is defined as;
Who may be able to join
- 21-55 years old with chronic neck pain, Males/Females
- Between 30-60 NRS 101 Scale
- ≥ 4 weeks mechanical neck pain
Who cannot join
- Cervical Spine Surgery
- Medically uncontrolled High Blood Pressure
- Past History of Stroke
- Upper Respiratory Infection within 4 weeks
- Current Symptoms of Dizziness
- Tinnitus, Blurred Vision, Vertigo, Sensory Motor Disturbance
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- Current use of anticoagulant therapy
- Connective Tissue Disorder
- Primary Fibromyalgia or myofascial pain
- Metabolic/Neoplastic Bone Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Novel Sham Cervical Spinal Manipulation Procedure.
Primary hypotheses:
Ho1: In chronic neck pain patients, randomly treated with either a "sham" or "real" cervical manipulation procedure, the probability of perceiving a Real Manipulation Procedure is equal to the probability of obtaining a Real Manipulation Procedure, AND, Ho2: Spinal tenderness will remain unchanged following the treatment procedure for both groups.
Secondary (null) hypotheses:
- Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will remain unchanged in both groups;
- there will be no differences between groups with respect to 2a) neck joint cavitations and 2b) forces across the cervical spine measured during the manoeuvres.
Read the detailed description
- Develop a randomized controlled clinical trial design to optimize the testing of the effects of a sham vs real cervical manipulation.
- Use novel modifications of both a sham a real manipulation to create "procedures" designed to optimize group equivalence in the RCT design. Then, evaluate the accuracy of 'patient post-treatment perception of treatment type' versus actual administered treatment (primary outcome #1).
- Quantitatively evaluate group differences in local soft-tissue tenderness by algometry (primary outcome #2), as well as changes in self-reported neck pain, ranges of motion, myoelectric responses in selected neck muscles and forces imparted during the procedures.
- Evaluate the occurrence of neck joint cavitation during the manoeuvres comprising these procedures.
- Conditions
- Chronic Neck Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
The perception by subjects as to whether they received a real treatment (YES/NO)
Measured: 10 mins
Change scores of the pressure algometry
Measured: 10 mins
Secondary outcomes (1)
Current Neck Pain, Ranges of Motion, MES Response will be analysed by comparing baseline, 15-and 120-minute score
Measured: approximately 1 hours +
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Memorial Chiropractic College
- Sponsor type
- University, hospital or other
- Investigators
- Howard Vernon, BA, DC, PhD, FCCS, FCCRS, Principal investigator, CMCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978094
- Sponsor's protocol ID
- 072155
- Other IDs
- 1R21AT004396-01A1
- Status last verified
- Nov 2010
- First submitted
- 15 Sep 2009
- Last updated
- 17 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Sham Cervical Spinal Manipulation Procedure.
- ClinicalTrials.gov ID
- NCT00978094
- Acronym / sponsor ID
- 072155
- Conditions
- Chronic Neck Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Canadian Memorial Chiropractic CollegeUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Sep 2009 (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.
Primary hypotheses:
Ho1: In chronic neck pain patients, randomly treated with either a "sham" or "real" cervical manipulation procedure, the probability of perceiving a Real Manipulation Procedure is equal to the probability of obtaining a Real Manipulation Procedure, AND, Ho2: Spinal tenderness will remain unchanged following the treatment procedure for both groups.
Secondary (null) hypotheses:
- Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will remain unchanged in both groups;
- there will be no differences between groups with respect to 2a) neck joint cavitations and 2b) forces across the cervical spine measured during the manoeuvres.
Detailed description
- Develop a randomized controlled clinical trial design to optimize the testing of the effects of a sham vs real cervical manipulation.
- Use novel modifications of both a sham a real manipulation to create "procedures" designed to optimize group equivalence in the RCT design. Then, evaluate the accuracy of 'patient post-treatment perception of treatment type' versus actual administered treatment (primary outcome #1).
- Quantitatively evaluate group differences in local soft-tissue tenderness by algometry (primary outcome #2), as well as changes in self-reported neck pain, ranges of motion, myoelectric responses in selected neck muscles and forces imparted during the procedures.
- Evaluate the occurrence of neck joint cavitation during the manoeuvres comprising these procedures.
Study design
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants in this study will be consenting adults, 21-55 years of age, male or female who have chronic mechanical neck pain (NP) rated as between 30 and 65 on an NRS-101 scale [74]. For the purposes of this study NP is defined as;
Key inclusion criteria (3 listed)
- 21-55 years old with chronic neck pain, Males/Females
- Between 30-60 NRS 101 Scale
- ≥ 4 weeks mechanical neck pain
Key exclusion criteria (10 listed)
- Cervical Spine Surgery
- Medically uncontrolled High Blood Pressure
- Past History of Stroke
- Upper Respiratory Infection within 4 weeks
- Current Symptoms of Dizziness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The perception by subjects as to whether they received a real treatment (YES/NO)
Time frame: 10 mins
Change scores of the pressure algometry
Time frame: 10 mins
1 secondary outcome
Current Neck Pain, Ranges of Motion, MES Response will be analysed by comparing baseline, 15-and 120-minute score
Time frame: approximately 1 hours +
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 17 Nov 2010.
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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 Vernon, BA, DC, PhD, FCCS, FCCRS principal investigator
CMCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic 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 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 17 Nov 2010. 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.
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?
The perception by subjects as to whether they received a real treatment (YES/NO) (time frame: 10 mins). The study lists 2 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 17 Nov 2010.