Specific Neck Rehabilitation for Unilateral Neck Related Headache and Structural Changes in the Brain
Summary
In part 1 of the project we will compare the clinical efficacy of specific neck rehabilitation with standard primary health care on patients with cervicogenic headache and study whether fear avoidance beliefs and self-efficacy predict long term neck function and headache frequency superior to the active range of neck movement.
In part 2 we will investigate whether patients with cervicogenic headache have changes in cerebral grey and white matter and in connectivity of the resting state network, whether these are reversed after effective neck rehabilitation, and correlate to symptom severity and degree of disability.
Description
The project includes two parts:
Part 1: With a longitudinal semicross-over randomized control design (n: 42) we will compare the clinical efficacy of 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. We will further 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.
Part 2: With a non-randomized comparative design we will investigate 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). Furthermore, we will test whether the anticipated cerebral changes in volume, structure and cerebral connectivity are reversed after specific neck rehabilitation, and whether they correlate to symptoms and 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.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Conditions
Cervicogenic Headache
Intervention
Specific neck rehabilitation, Standard primary health care
Status
Not yet recruiting
Source
University of Tromso
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT02908984
- ClinicalTrials.gov processed this data on September 21, 2016
Published on BioPortfolio: 2016-09-21T20:23:22-0400
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Medical and Biotech [MESH] Definitions
Primary Health Care
Care which provides integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. (JAMA 1995;273(3):192)
Episode Of Care
An interval of care by a health care facility or provider for a specific medical problem or condition. It may be continuous or it may consist of a series of intervals marked by one or more brief separations from care, and can also identify the sequence of care (e.g., emergency, inpatient, outpatient), thus serving as one measure of health care provided.
Nurses, Community Health
Nurses whose work combines elements of both primary care nursing and public health practice and takes place primarily outside the therapeutic institution. Primary nursing care is directed to individuals, families, or groups in their natural settings within communities.
Comprehensive Health Care
Providing for the full range of personal health services for diagnosis, treatment, follow-up and rehabilitation of patients.
Managed Care Programs
Health insurance plans intended to reduce unnecessary health care costs through a variety of mechanisms, including: economic incentives for physicians and patients to select less costly forms of care; programs for reviewing the medical necessity of specific services; increased beneficiary cost sharing; controls on inpatient admissions and lengths of stay; the establishment of cost-sharing incentives for outpatient surgery; selective contracting with health care providers; and the intensive management of high-cost health care cases. The programs may be provided in a variety of settings, such as HEALTH MAINTENANCE ORGANIZATIONS and PREFERRED PROVIDER ORGANIZATIONS.
