MigraineNCT01980927
Changes in Intracranial Compliance in Migraine Subjects Following a National Upper Cervical Chiropractic Association Atlas Correction
A study testing NUCCA atlas correction in people with Migraine, run by University of Calgary at 1 site in Canada.
Trial summary
A small number of chiropractors, who align only the atlas C-1, or "top" vertebra in the spine, practice the National Upper Cervical Chiropractic Association (NUCCA) atlas correction procedure. This procedure uses a precise, non-invasive, gentle touch technique to correct misalignment of the atlas. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- NUCCA atlas correction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Nov 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18-65 years of age.
- Be naive to Upper Cervical Chiropractic care. Other forms of chiropractic care in the past are permitted.
- Have migraine with or without aura.
- Have between 10-26 headache days per month over the last 4 months.
- Have at least 4 separate headache episodes per month, with episodes separated by at least 4 hours of painfree time.
- Have at least 8 days per month with pain of levels greater than or equal to 4/10 for part of the day, or have attacks successfully treated with migraine specific medication.
- Be candidates suitable for NUCCA therapeutic intervention because of atlas displacement as assessed by NUCCA investigator.
- Subjects on acceptable pharmacological prophylaxis must either remain on a stable dose throughout the study, or stop the prophylactic medication one month before entering the baseline period.
Who cannot join
- Any medical or psychiatric condition which in the opinion of the investigator would make the subject unsuitable for enrolment, because of inability to comply with study requirements or possible confounding of the results.
- Headache on more than 26 days per month.
- Acute medication overuse as defined by the International Classification of Headache Disorders.
- Pregnancy or lactation
- Severe cervical spine degeneration as assessed by cervical spine x-ray.
- Claustrophobia or any condition that contraindicates an MRI scan
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- A history of cardiovascular disease, cerebrovascular disease, brain surgery, or other central nervous system disorder.
- Other chronic pain disorder which might interfere with headache assessment or study procedures.
- A history of significant hypo- or hypertension as determined by the investigator.
- Subject on a beta-blocker, calcium channel blocker, or other medication which the investigator considers might alter cerebral vascular regulation. Triptans are allowed, but must not be taken within 24 hours (48 hours for frovatriptan) before an MRI study.
- A history of substance abuse or dependence within 1 year.
- Current participation in a research study or within the last 30 days.
- Any spinal chiropractic care outside of the study protocol is prohibited during the baseline and treatment period.
- Use of botulinum A within 4 months of study entry.
- A history of significant head or neck trauma (as judged by the investigator) within the year prior to study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Intracranial Compliance in Migraine Subjects Following a National Upper Cervical Chiropractic Association (NUCCA)Atlas Correction Intervention - a Pilot Study
A small number of chiropractors, who align only the atlas C-1, or "top" vertebra in the spine, practice the National Upper Cervical Chiropractic Association (NUCCA) atlas correction procedure. This procedure uses a precise, non-invasive, gentle touch technique to correct misalignment of the atlas. Although NUCCA practitioners have long used this procedure in the treatment of headache, it has not been formally studied using clinical trials. There is some data indicating that NUCCA correction can increase intracranial compliance. This intracranial compliance can be measured by a magnetic resonance imaging (MRI) study before and then after a NUCCA procedure. In this study, the investigators hope to show that the correction of an atlas misalignment will increase intracranial compliance in subjects with migraine.
- Conditions
- Migraine
- Being tested
- NUCCA atlas correction
- Keywords
- Migraine, National Upper Cervical Chiropractic Association atlas correction
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUCCA atlas correctionProcedure or surgery
A chiropractic procedure involving correcting a misalignment of the atlas or "top" vertebra in the spine.
| Study group | Role | What they receive |
|---|---|---|
| NUCCA atlas correction | Experimental | NUCCA atlas correction for migraine patients Receives: Procedure: NUCCA atlas correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intracranial compliance; comparing the baseline period to one month post treatment, 4 weeks after initiation of NUCCA care and maintained correction of atlas misalignment, as measured by phase contrast magnetic resonance imaging.
Measured: At baseline, at 4 weeks, at 8 weeks
Secondary outcomes (2)
Days with headache per month
Patients use headache diaries to track the number of days with headaches.
Measured: At baseline, at 4 weeks, at 8 weeks
Average headache intensity on headache days
Patients rate headache pain from 0-10 on 3 segments of the day (morning, afternoon, evening) using headache diaries. These numbers are used to calculate the average intensity of the headache on headache days.
Measured: At baseline, at 4 weeks, at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startNov 2011
- Primary completionJan 2013
- Study completionNov 2014
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 MigraineStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Werner Becker, University of Calgary
- Investigators
- Werner Becker, MD, FRCPC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980927
- Sponsor's protocol ID
- 24116
- Status last verified
- Dec 2014
- First submitted
- 4 Nov 2013
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Woodfield HC 3rd, Hasick DG, Becker WJ, Rose MS, Scott JN. Effect of Atlas Vertebrae Realignment in Subjects with Migraine: An Observational Pilot Study. Biomed Res Int. 2015;2015:630472. doi: 10.1155/2015/630472. Epub 2015 Dec 10.
PubMed 26783523
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Intracranial Compliance in Migraine Subjects Following a National Upper Cervical Chiropractic Association (NUCCA)Atlas Correction Intervention - a Pilot Study
- ClinicalTrials.gov ID
- NCT01980927
- Acronym / sponsor ID
- 24116
- Conditions
- Migraine
- Keywords
- Migraine, National Upper Cervical Chiropractic Association atlas correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Nov 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.
A small number of chiropractors, who align only the atlas C-1, or "top" vertebra in the spine, practice the National Upper Cervical Chiropractic Association (NUCCA) atlas correction procedure. This procedure uses a precise, non-invasive, gentle touch technique to correct misalignment of the atlas. Although NUCCA practitioners have long used this procedure in the treatment of headache, it has not been formally studied using clinical trials. There is some data indicating that NUCCA correction can increase intracranial compliance. This intracranial compliance can be measured by a magnetic resonance imaging (MRI) study before and then after a NUCCA procedure. In this study, the investigators hope to show that the correction of an atlas misalignment will increase intracranial compliance in subjects with migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NUCCA atlas correction | Experimental | Procedure: NUCCA atlas correctionNUCCA atlas correction for migraine patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must be 18-65 years of age.
- Be naive to Upper Cervical Chiropractic care. Other forms of chiropractic care in the past are permitted.
- Have migraine with or without aura.
- Have between 10-26 headache days per month over the last 4 months.
- Have at least 4 separate headache episodes per month, with episodes separated by at least 4 hours of painfree time.
Key exclusion criteria (15 listed)
- Any medical or psychiatric condition which in the opinion of the investigator would make the subject unsuitable for enrolment, because of inability to comply with study requirements or possible confounding of the results.
- Headache on more than 26 days per month.
- Acute medication overuse as defined by the International Classification of Headache Disorders.
- Pregnancy or lactation
- Severe cervical spine degeneration as assessed by cervical spine x-ray.
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 |
|---|---|---|
| NUCCA atlas correctionA chiropractic procedure involving correcting a misalignment of the atlas or "top" vertebra in the spine. | Procedure or surgery | NUCCA atlas correction |
Primary outcome
Change in intracranial compliance; comparing the baseline period to one month post treatment, 4 weeks after initiation of NUCCA care and maintained correction of atlas misalignment, as measured by phase contrast magnetic resonance imaging.
Time frame: At baseline, at 4 weeks, at 8 weeks
2 secondary outcomes
Days with headache per month
Time frame: At baseline, at 4 weeks, at 8 weeks
Average headache intensity on headache days
Time frame: At baseline, at 4 weeks, at 8 weeks
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 12 Dec 2014.
- Derived from this study: PubMed 26783523Woodfield HC 3rd, Hasick DG, Becker WJ, Rose MS, Scott JN. Effect of Atlas Vertebrae Realignment in Subjects with Migraine: An Observational Pilot Study. Biomed Res Int. 2015;2015:630472. doi: 10.1155/2015/630472. Epub 2015 Dec 10.
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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.
Werner Becker, MD, FRCPC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUCCA atlas correction in people with Migraine, run by University of Calgary 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 8 inclusion and 15 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 12 Dec 2014. 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?
Change in intracranial compliance; comparing the baseline period to one month post treatment, 4 weeks after initiation of NUCCA care and maintained correction of atlas misalignment, as measured by phase contrast magnetic resonance imaging. (time frame: At baseline, at 4 weeks, at 8 weeks). 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 NCT01980927, 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 12 Dec 2014.