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Specific Neck Rehabilitation for Unilateral Neck Related Headache and Structural Changes in the Brain

This study is currently recruiting participants.
Verified October 2016 by University of Tromso
Sponsor:
ClinicalTrials.gov Identifier:
NCT02908984
First Posted: September 21, 2016
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
The Royal Norwegian Ministry of Health
Information provided by (Responsible Party):
University of Tromso
  Purpose
In part 1 of the project clinical efficacy of specific neck rehabilitation will be compared with standard primary health care among patients with cervicogenic headache and 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 changes in cerebral grey and white matter and in connectivity of the resting state state network, whether these are reversed after effective neck rehabilitation, and correlate to symptom severity and degree of disability.

Condition Intervention
Cervicogenic Headache Behavioral: Specific neck rehabilitation Other: Standard primary health care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Specific Neck Rehabilitation on Unilateral Neck Related Headache, and Structural Changes of Cerebral Gray and White Matter

Resource links provided by NLM:


Further study details as provided by University of Tromso:

Primary Outcome Measures:
  • Difference of days with headache pr week after specific neck rehabilitation vs standard primary health care [ Time Frame: 6 months after baseline ]
    Two independent group comparison with a numeric variable (scale 0-7)

  • Differences in cerebral grey matter volume in patients with unilateral headache and neck pain vs. healthy controls [ Time Frame: Baseline ]
    Voxel based volumetric analyses of cerebral grey matter


Secondary Outcome Measures:
  • Difference in pain intensity after specific neck rehabilitation vs. standard primary health care [ Time Frame: 6 months after baseline ]
    Two independent group comparison with a numeric variable (scale 0-10)

  • Improved neck function after specific neck rehabilitation vs. standard primary health care [ Time Frame: 6 months after baseline ]
    Two independent group comparison with a numeric variable (scale 0-100)

  • Differences in white matter integrity in patients with unilateral headache and neck pain vs. healthy controls [ Time Frame: Baseline ]
    Diffusion tensor imaging with tract based spatial statistics analyses

  • Difference in white matter integrity after specific neck rehabilitation vs standard primary health care [ Time Frame: 6 months after baseline ]
    Diffusion tensor imaging with tract based spatial statistics analyses

  • How four week baseline headache intensity reported by a numeric rating scale is associated with regional cerebral grey matter volume measured by voxel based morphometry in patients with unilateral headache and neck pain. [ Time Frame: Baseline ]
    A linear regression analysis will be performed where the voxel based volumetric measure of cerebral grey matter (VBM) 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.

  • How baseline perceived cognitive function predicts volumetric differences of cerebral grey matter in patients with unilateral headache and neck pain [ Time Frame: Baseline ]
    Linear regression analysis of voxel based volumetric measures of grey matter (continuous data) and scores of Everyday Memory Questionnaire (scale 0-8).

  • How baseline active range of neck movement predicts neck function [ Time Frame: 12 months after baseline ]
    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, sick-leave.

  • How baseline active range of neck movement predicts headache frequency [ Time Frame: 12 months after baseline ]
    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, sick-leave.

  • How baseline self efficacy predicts neck function [ Time Frame: 12 months after baseline ]
    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, sick-leave.

  • How baseline self efficacy predicts headache frequency [ Time Frame: 12 months after baseline ]
    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, sick-leave.

  • How baseline fear avoidance beliefs for physical activity predict neck function [ Time Frame: 12 months after baseline ]
    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, sick-leave.

  • How baseline fear avoidance beliefs for physical activity predict headache frequency [ Time Frame: 12 months after baseline ]
    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.

  • Difference in intra-network connectivity of the DMN in patients with unilateral headache and neck pain vs. healthy controls. [ Time Frame: Baseline ]
    Baseline RS-fMRI data will be used 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.

  • Change of DMN connectivity in patients who report reduction in headache attacks. [ Time Frame: 6 months after baseline ]
    Whether DMN connectivity change from baseline to 6 months after baseline will be tested in the patient group. This will be statistically tested in a repeated measure GLM in the GIFT with DMN connectivity as the dependent variable, and the number of headache attacks as the main predictor variable.

  • Changes of DMN connectivity related to pain relief after specific neck rehabilitation. [ Time Frame: 6 months ]
    DMN connectivity and other major networks will be used as dependent variables in a multivariate GLM with pain reports as the main covariate.

  • Changes of DMN connectivity related to improved craniocervical flexion endurance capacity after specific neck rehabilitation. [ Time Frame: 6 months ]
    DMN connectivity and other major networks will be used as dependent variables in a multivariate GLM with craniocervical flexion endurance capacity as the main covariate.


Estimated Enrollment: 42
Study Start Date: October 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Specific neck rehabilitation
The intervention includes specific neck rehabilitation as described by Jull and Falla over a 4 period of weeks and recommendations for further training.
Behavioral: Specific neck rehabilitation
Guided craniocervical, axioscapular and proprioceptive training that includes education, postural exercises, as well as training of cervical and shoulder muscles, and of oculomotor function if indicated, and general exercises
Active Comparator: Standard primary health care
This represents individualized therapy administered by the primary physician.
Other: Standard primary health care
The treatment includes individualized based pharmacological medication and physiotherapy or no active treatment

Detailed Description:

The project includes two parts:

Part 1: With a longitudinal semicross-over randomized control design (n: 42) the investigators will compare the clinical efficacy of a 6 month specific neck rehabilitation with standard primary health care on patients with cervicogenic headache. 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. 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 will further be studied.

Part 2: With a non-randomized comparative design the investigators will explore whether there are changes in the cerebral grey and white matter volume and structure measured by volumetric MRi and diffusion tensor imaging (DTI), and whether cerebral connectivity within the default mode network (DMN) are significantly different between patients with cervicogenic headache and healthy controls. Cerebral connectivity will be measured 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, and whether these changes correlate to symptom severity and degree of disability

Analyses of MRI scans and clinical characteristics will be performed before each treatment session and 6 months later. Baseline data will be compared with corresponding data from 25 healthy controls not receiving any treatment.

Those who are performing the analyses are blinded to group assignment.

Statistics: Power calculations based on a previous studies and pilot data indicate that a number of 21 patients within each treatment group and 25 health controls would be sufficient to obtain a statistical power of 80% with a p-value of 5% for both part 1 and 2. Baseline and 6 month data will be used for "between group" comparisons while 12 months data wil also be included for for "within-group" comparisons. Statistical predictor analyses will be performed by regression analyses.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Unilateral headache and neck pain for 2 or more
  • Minimum one headache attack pr week (numeric rating scale ≥4)
  • Five of Antonaci's seven diagnostic criteria
  • Neck Disability Index score >8 Points (16 percent points).

For healthy controls:

• Same age distribution

Exclusion Criteria:

  • Progressive diseases (rheumatoid arthritis, cancer)
  • Ongoing cervical infection
  • Neurological disease (syringomyelia, radiculopathy, multiple sclerosis, Parkinson's disease)
  • Other systemic diseases (Hypertension, hyperlipidemia, diabetes mellitus, heart disease, cerebrovascular or other vascular diseases)
  • Other headache (>1 tension type headache or migraine attack every month)
  • Other pain conditions (including temporomandibular disorder and generalized pain (fibromyalgia with pain intensity >6 to digital palpation)
  • Dysmenorrhea requiring analgesics or other pain conditions.
  • Previous or ongoing drug abuse
  • Serious psychiatric disorder.
  • Hopkins Symptom Checklist-25 score for depressive symptoms > 2.2
  • Ongoing litigation process
  • Intolerance to MRI
  • Pregnancy and lactation

For healthy controls:

  • Exclusion criteria as above
  • Chronic pain
  • Chronic dizziness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908984


Contacts
Contact: Gunnvald Kvarstein, PhD +4792295309 gunnvald.kvarstein@uit.no
Contact: Sissel Roland, Cand. med. +4747397941 sisselro@gmail.com

Locations
Norway
University Hospital of North Norway Recruiting
Tromso, Norway, 9019
Contact: Gunnvald Kvarstein, PhD    +4792295309    gunnvald.kvarstein@uit.no   
Contact: Sissel Roland, Cand. Med    +4747397941    sisselro@gmail.com   
Sponsors and Collaborators
University of Tromso
The Royal Norwegian Ministry of Health
Investigators
Principal Investigator: Gunnvald Kvarstein, PhD UiT The Arctic University of Tromsø
  More Information

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT02908984     History of Changes
Other Study ID Numbers: 2014/1652
First Submitted: January 14, 2016
First Posted: September 21, 2016
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Tromso:
unilateral headache
cervical pain
neck pain
voxel based morphometry
diffusion tensor imaging
structural brain changes
rehabilitation

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases