Cervicogenic HeadacheNCT02908984
Specific Neck Rehabilitation for Unilateral Headache and Neck Pain, and Structural and Functional Changes in the Brain
A study testing Specific neck rehabilitation and Standard primary health care in people with Cervicogenic Headache, run by University of Tromso at 1 site in Norway.
Trial summary
In part 1 of the project clinical effect of specific neck rehabilitation for unilateral headache and neck pain (also termed cervicogenic headache) will be compared with standard primary health care. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Specific neck rehabilitation and Standard primary health care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2016to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unilateral headache and neck pain for 2 years or more
- Minimum one headache attack pr week (numeric rating scale ≥4)
- Five or more of Antonaci's seven diagnostic criteria
- Neck Disability Index score ≥8 Points (≥16 percent points).
- For healthy controls:
- Same age distribution
Who cannot join
- Progressive diseases (rheumatoid arthritis, cancer)
- Ongoing cervical infection
- Neurological disease (syringomyelia, radiculopathy, multiple sclerosis, Parkinson's disease, ischemic stroke )
- Other headache (>1 tension type headache or migraine attack every month)
- Other pain conditions (including primary temporomandibular disorder and generalized pain (fibromyalgia with pain intensity >6 to digital palpation)
- Previous or ongoing drug abuse
Show all 17Show fewer
- Serious psychiatric disorder.
- Hopkins Symptom Checklist-25 score for depressive symptoms > 2.2
- Ongoing litigation process
- Intolerance to MRI
- Pregnancy and lactation
- For the subsample undergoing MR analyses: Other systemic diseases (Hypertension, hyperlipidemia, diabetes mellitus, heart disease, cerebrovascular, epilepsy or other vascular diseases) and dysmenorrhea requiring analgesics
- For healthy controls:
- Chronic pain
- Chronic dizziness
- Intolerance to MRI
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Specific Neck Rehabilitation on Patients With Unilateral Headache and Neck Pain (Cervicogenic Headache), and Relation to Structural and Functional Changes in the Brain
In part 1 of the project clinical effect of specific neck rehabilitation for unilateral headache and neck pain (also termed cervicogenic headache) will be compared with standard primary health care. The researchers will further study whether fear avoidance beliefs and self-efficacy predict long term neck function and headache frequency superior to active range of neck movement. Part 2 will investigate whether patients with cervicogenic headache have structural changes in cerebral grey and white matter and in connectivity of the resting state state network, and whether these are reversed after effective neck rehabilitation and correlate to symptom severity and degree of disability.
Read the detailed description
The project includes two parts:
Part 1: With a longitudinal semicross-over, randomized control design the investigators will compare the clinical efficacy of a 6 month specific neck rehabilitation with standard primary health care on patients with unilateral headache and neck pain ( also termed cervicogenic headache) and study whether self-efficacy and fear avoidance beliefs predict 12 month self-reported neck function and headache frequency superior to the active range of neck movement The patients will either receive a specific neck rehabilitation program or 6 month standard primary health care before they cross over to neck rehabilitation. Sociodemographic and clinical characteristics will be collected before each treatment session and 6 and 12 months later.
Part 2: With a non-randomized comparative design including a subsample of the patients (n: 36) and healthy controls (n: 36) the investigators will explore whether there are structural changes in the cerebral grey and white matter, and whether cerebral connectivity within the default mode network (DMN and other major cerebral networks) are significantly different and whether the changes correlate to symptom severity and degree of disability.
Structural (cortical volume and thickness) changes will measured by volumetric magnetic resonance imaging (MRi) and diffusion tensor imaging (DTI), while cerebral connectivity by resting state fMRI (rs-fMRI). Whether the anticipated cerebral changes in volume, structure and connectivity are reversed after specific neck rehabilitation will be tested by repeated measurements. Analyses of MRI scans and clinical characteristics will be performed before each treatment session and 6 months later.
Statistics: A parallel design power calculations based on previous studies indicated that for the clinical part a number of 21 patients within each treatment group (a total of 42 patients) and for the MR analyses a subsample of 34 patients and 34 health controls will be sufficient to obtain a statistical power of 80% with a p-value of 5%. Given a 2:1 ratio following a semi-cross over design, normal distributed data, α = 0.05, different standard deviations for each group (SD 1,38 and 1,71), and a statistical power of 0,8, a calculation indicated a sample size of 36 patients for the RCT. With a dropout rate up to 35%, 54 participants would be satisfactory.
Changes between baseline and the 6 month follow up will be used for "between and within group" comparisons while 12 months data will be included for in "within-group" comparisons. Statistical predictor analyses will be performed by regression analyses. The statistician who are performing the primary end point analysis, are blinded to group assignment.
- Conditions
- Cervicogenic Headache
- Being tested
- Specific neck rehabilitation, Standard primary health care
- Keywords
- unilateral headache, cervical pain, neck pain, rehabilitation, structural brain changes, surface based volumetry, diffusion tensor imaging, functional brain changes, sensorimotor control, craniocervical flexion, vestibular rehabilitation, cortical thickness
- Medical subject headings
- Post-Traumatic Headache, Headache, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific neck rehabilitationBehavioural
Guided craniocervical, axioscapular and proprioceptive training that includes education, postural exercises, as well as training of cervical and shoulder muscles, and vestibular rehabilitation, included oculomotor function if indicated, and general exercises
Standard primary health careOther
The treatment may include pharmacological medication, chiropractic and physiotherapy or no active treatment
| Study group | Role | What they receive |
|---|---|---|
| Specific neck rehabilitation | Experimental | The intervention includes specific neck rehabilitation as described by Jull and Falla over a period of 4 weeks and recommendations for further training. Receives: Behavioral: Specific neck rehabilitation |
| Standard primary health care | Active comparator | This represents individualized therapy administered by the primary physician. Receives: Other: Standard primary health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of days with headache pr week after specific neck rehabilitation vs standard primary health care
Between group comparison with a numeric variable (scale 0-7)
Measured: 6 months after baseline
Differences in grey matter volume of the brain and brain stem between patients with unilateral headache and neck pain vs. healthy controls
Two independent group comparison based on volumetric analysis of cerebral grey matter also including surface based measurements (continuous variable)
Measured: Baseline
Differences in cortical thickness between patients with unilateral headache and neck pain vs. healthy controls
Two independent group comparison based on surface based analyses of cerebral grey matter carried out with FreeSurfer version 6.0
Measured: Baseline
Secondary outcomes (18)
Difference in pain intensity after specific neck rehabilitation vs. standard primary health care
Between group comparison with a numeric variable (scale 0-10)
Measured: 6 months after baseline
Improved neck function after specific neck rehabilitation vs. standard primary health care
Between group comparison with a numeric variable (scale 0-50)
Measured: 6 months after baseline
Change in grey matter volume of the brain and brain stem in patients with unilateral headache and neck pain after specific neck rehabilitation
Within group comparison based on volumetric analysis of cerebral grey matter also including surface based measurements (continuous variable)
Measured: 6 months
Change in cortical thickness of the brain between patients with unilateral headache and neck pain after specific neck rehabilitation
Within group comparison based on surface based volumetric analysis of cerebral grey matter (continous variable)
Measured: 6 months
Differences in white matter integrity in patients with unilateral headache and neck pain vs. healthy controls
Two independent group comparison based on diffusion tensor imaging with tract based spatial statistics analyses
Measured: Baseline
Difference in white matter integrity after specific neck rehabilitation vs standard primary health care
Between group comparison based on diffusion tensor imaging with tract based spatial statistics analyses
Measured: 6 months after baseline
How four week baseline headache intensity reported by a numeric rating scale is associated with regional grey matter volumes measured by surface based volumetry in patients with unilateral headache and neck pain.
Linear regression analysis will be performed where the surface based volumetric measure of cerebral grey matter is the dependent variable, and four week baseline headache intensity is independent variable. Baseline headache intensity is based on daily measures during the last 4 weeks and is reported by an electronic diary and numeric rating scale where 0 is no pain and 10 is worst imaginable pain. It is thus considered a continuous measure. Age and gender are included as covariates.
Measured: Baseline
How baseline perceived cognitive function predicts volumetric differences of cerebral grey matter in patients with unilateral headache and neck pain
Linear regression analysis of surface based volumetric measures of grey matter (continuous data) and scores of Everyday Memory Questionnaire (scale 0-8).
Measured: Baseline
How baseline active range of neck movement predicts neck function
A logistic regression analysis on how baseline active range of neck movement (continuous data, degrees of rotation) predicts a 30% reduction in Neck Disability Index Score (0-50). Co-factors are age, gender, education, sick-leave.
Measured: 12 months after baseline
How baseline active range of neck movement predicts headache frequency
A logistic regression analysis on how baseline active range of neck movement (continuous data, degrees of rotation) predicts a 30% reduction in headache frequency (0-7). Co-factors are age, gender, education, sick-leave.
Measured: 12 months after baseline
How baseline self efficacy predicts neck function
A logistic regression analysis on how baseline General self efficacy scale score (scale 10-40) predicts a 30% reduction in Neck Disability Index Score (0-50). Co-factors are age, gender, education, sick-leave.
Measured: 12 months after baseline
How baseline self efficacy predicts headache frequency
A logistic regression analysis on how baseline General self efficacy scale score (scale 10-40) predicts a 30% reduction in headache frequency (0-7). Co-factors are age, gender, education, sick-leave.
Measured: 12 months after baseline
How baseline fear avoidance beliefs for physical activity predict neck function
A logistic regression analysis on how baseline fear avoidance beliefs score predict a 30% reduction in Neck Disability Index Score (0-50). Co-factors are age, gender, education, sick-leave.
Measured: 12 months after baseline
How baseline fear avoidance beliefs for physical activity predict headache frequency
A logistic regression analysis on how baseline fear avoidance beliefs for physical activity score predict a 30% reduction in headache frequency (0-7). Co-factors are age, gender, education, sick-leave.
Measured: 12 months after baseline
Difference in intra-network connectivity of resting state networks in patients with unilateral headache and neck pain vs. healthy controls.
Two independent comparison based on baseline rs-fMRI data to compare patients and controls. In multivariate general linear models, the investigators will use DMN and other major cerebral networks, identified by independent component analysis (ICA), as dependent variables and test whether there are differences in cerebral connectivity between patients and controls. All rs-fMRI analyses will be performed with the GIFT software http://mialab.mrn.org/software/gift/index.html. An ICA procedure in GIFT will be used to identify functional networks. GIFT that has a MatLab based statistical module for general linear modelling (GLM) of rs-fMRI data that will be used for all rs-fMRI analyses.
Measured: Baseline
Change of resting state connectivity in patients who report reduction in headache attacks.
Within group comparison of resting state networks between baseline and 6 months follow up in a repeated measure GLM in the GIFT. Connectivity of DMN and other major networks is dependent variable and change in number of headache attacks main predictor variable.
Measured: 6 months after baseline
Changes of resting state connectivity related to pain relief after specific neck rehabilitation.
Within group comparison of resting state networks between baseline and 6 months follow up in a multivariate GLM. Change of connectiviy in DMN and other major networks is dependent variables and pain reports main covariate.
Measured: 6 months
Changes in connectivity of resting state networks related to improved craniocervical flexion endurance capacity after specific neck rehabilitation.
Within group comparison of resting state networks between baseline and 6 months follow in a multivariate GLM. Connectivity of DMN and other major networks is dependent variables and craniocervical flexion endurance capacity main covariate.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startOct 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Responsible party
- Sponsor
- Investigators
- Gunnvald Kvarstein, PhD, Principal investigator, UiT The Arctic University of Tromsø
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908984
- Sponsor's protocol ID
- 2014/1652
- Status last verified
- Apr 2025
- First submitted
- 14 Jan 2016
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Specific Neck Rehabilitation on Patients With Unilateral Headache and Neck Pain (Cervicogenic Headache), and Relation to Structural and Functional Changes in the Brain
- ClinicalTrials.gov ID
- NCT02908984
- Acronym / sponsor ID
- 2014/1652
- Conditions
- Cervicogenic Headache
- Keywords
- unilateral headache, cervical pain, neck pain, rehabilitation, structural brain changes, surface based volumetry, diffusion tensor imaging, functional brain changes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Study start
- Oct 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Sep 2016 (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.
In part 1 of the project clinical effect of specific neck rehabilitation for unilateral headache and neck pain (also termed cervicogenic headache) will be compared with standard primary health care. The researchers will further study whether fear avoidance beliefs and self-efficacy predict long term neck function and headache frequency superior to active range of neck movement. Part 2 will investigate whether patients with cervicogenic headache have structural changes in cerebral grey and white matter and in connectivity of the resting state state network, and whether these are reversed after effective neck rehabilitation and correlate to symptom severity and degree of disability.
Detailed description
The project includes two parts:
Part 1: With a longitudinal semicross-over, randomized control design the investigators will compare the clinical efficacy of a 6 month specific neck rehabilitation with standard primary health care on patients with unilateral headache and neck pain ( also termed cervicogenic headache) and study whether self-efficacy and fear avoidance beliefs predict 12 month self-reported neck function and headache frequency superior to the active range of neck movement The patients will either receive a specific neck rehabilitation program or 6 month standard primary health care before they cross over to neck rehabilitation. Sociodemographic and clinical characteristics will be collected before each treatment session and 6 and 12 months later.
Part 2: With a non-randomized comparative design including a subsample of the patients (n: 36) and healthy controls (n: 36) the investigators will explore whether there are structural changes in the cerebral grey and white matter, and whether cerebral connectivity within the default mode network (DMN and other major cerebral networks) are significantly different and whether the changes correlate to symptom severity and degree of disability.
Structural (cortical volume and thickness) changes will measured by volumetric magnetic resonance imaging (MRi) and diffusion tensor imaging (DTI), while cerebral connectivity by resting state fMRI (rs-fMRI). Whether the anticipated cerebral changes in volume, structure and connectivity are reversed after specific neck rehabilitation will be tested by repeated measurements. Analyses of MRI scans and clinical characteristics will be performed before each treatment session and 6 months later.
Statistics: A parallel design power calculations based on previous studies indicated that for the clinical part a number of 21 patients within each treatment group (a total of 42 patients) and for the MR analyses a subsample of 34 patients and 34 health controls will be sufficient to obtain a statistical power of 80% with a p-value of 5%. Given a 2:1 ratio following a semi-cross over design, normal distributed data, α = 0.05, different standard deviations for each group (SD 1,38 and 1,71), and a statistical power of 0,8, a calculation indicated a sample size of 36 patients for the RCT. With a dropout rate up to 35%, 54 participants would be satisfactory.
Changes between baseline and the 6 month follow up will be used for "between and within group" comparisons while 12 months data will be included for in "within-group" comparisons. Statistical predictor analyses will be performed by regression analyses. The statistician who are performing the primary end point analysis, are blinded to group assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific neck rehabilitation | Experimental | Behavioral: Specific neck rehabilitationThe intervention includes specific neck rehabilitation as described by Jull and Falla over a period of 4 weeks and recommendations for further training. |
| Standard primary health care | Active comparator | Other: Standard primary health careThis represents individualized therapy administered by the primary physician. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Unilateral headache and neck pain for 2 years or more
- Minimum one headache attack pr week (numeric rating scale ≥4)
- Five or more of Antonaci's seven diagnostic criteria
- Neck Disability Index score ≥8 Points (≥16 percent points).
- Same age distribution
Key exclusion criteria (17 listed)
- Progressive diseases (rheumatoid arthritis, cancer)
- Ongoing cervical infection
- Neurological disease (syringomyelia, radiculopathy, multiple sclerosis, Parkinson's disease, ischemic stroke )
- Other headache (>1 tension type headache or migraine attack every month)
- Other pain conditions (including primary temporomandibular disorder and generalized pain (fibromyalgia with pain intensity >6 to digital palpation)
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 |
|---|---|---|
| Specific neck rehabilitationGuided craniocervical, axioscapular and proprioceptive training that includes education, postural exercises, as well as training of cervical and shoulder muscles, and vestibular rehabilitation, included oculomotor function if indicated, and general exercises | Behavioural | Specific neck rehabilitation |
| Standard primary health careThe treatment may include pharmacological medication, chiropractic and physiotherapy or no active treatment | Other | Standard primary health care |
Primary outcome
Difference of days with headache pr week after specific neck rehabilitation vs standard primary health care
Time frame: 6 months after baseline
Between group comparison with a numeric variable (scale 0-7)
Differences in grey matter volume of the brain and brain stem between patients with unilateral headache and neck pain vs. healthy controls
Time frame: Baseline
Two independent group comparison based on volumetric analysis of cerebral grey matter also including surface based measurements (continuous variable)
Differences in cortical thickness between patients with unilateral headache and neck pain vs. healthy controls
Time frame: Baseline
Two independent group comparison based on surface based analyses of cerebral grey matter carried out with FreeSurfer version 6.0
18 secondary outcomes
Difference in pain intensity after specific neck rehabilitation vs. standard primary health care
Time frame: 6 months after baseline
Improved neck function after specific neck rehabilitation vs. standard primary health care
Time frame: 6 months after baseline
Change in grey matter volume of the brain and brain stem in patients with unilateral headache and neck pain after specific neck rehabilitation
Time frame: 6 months
Change in cortical thickness of the brain between patients with unilateral headache and neck pain after specific neck rehabilitation
Time frame: 6 months
Differences in white matter integrity in patients with unilateral headache and neck pain vs. healthy controls
Time frame: Baseline
Difference in white matter integrity after specific neck rehabilitation vs standard primary health care
Time frame: 6 months after baseline
How four week baseline headache intensity reported by a numeric rating scale is associated with regional grey matter volumes measured by surface based volumetry in patients with unilateral headache and neck pain.
Time frame: Baseline
How baseline perceived cognitive function predicts volumetric differences of cerebral grey matter in patients with unilateral headache and neck pain
Time frame: Baseline
How baseline active range of neck movement predicts neck function
Time frame: 12 months after baseline
How baseline active range of neck movement predicts headache frequency
Time frame: 12 months after baseline
How baseline self efficacy predicts neck function
Time frame: 12 months after baseline
How baseline self efficacy predicts headache frequency
Time frame: 12 months after baseline
How baseline fear avoidance beliefs for physical activity predict neck function
Time frame: 12 months after baseline
How baseline fear avoidance beliefs for physical activity predict headache frequency
Time frame: 12 months after baseline
Difference in intra-network connectivity of resting state networks in patients with unilateral headache and neck pain vs. healthy controls.
Time frame: Baseline
Change of resting state connectivity in patients who report reduction in headache attacks.
Time frame: 6 months after baseline
Changes of resting state connectivity related to pain relief after specific neck rehabilitation.
Time frame: 6 months
Changes in connectivity of resting state networks related to improved craniocervical flexion endurance capacity after specific neck rehabilitation.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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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.
Gunnvald Kvarstein, PhD principal investigator
UiT The Arctic University of Tromsø
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific neck rehabilitation and Standard primary health care in people with Cervicogenic Headache, run by University of Tromso at 1 site in Norway.
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 6 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2025. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Difference of days with headache pr week after specific neck rehabilitation vs standard primary health care (time frame: 6 months after baseline). 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?
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 4 May 2025.