Last updated on March 2019

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


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT02908984

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