Specific Neck Rehabilitation for Unilateral Headache and Neck Pain, and Structural and Functional Changes in the Brain

NCT ID: NCT02908984

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Cervicogenic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Specific neck rehabilitation

The intervention includes specific neck rehabilitation as described by Jull and Falla over a period of 4 weeks and recommendations for further training.

Group Type: EXPERIMENTAL

Specific neck rehabilitation

Intervention Type: BEHAVIORAL

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 care

This represents individualized therapy administered by the primary physician.

Group Type: ACTIVE_COMPARATOR

Standard primary health care

Intervention Type: OTHER

The treatment may include pharmacological medication, chiropractic and physiotherapy or no active treatment

Interventions

Specific neck rehabilitation

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

Intervention Type: BEHAVIORAL

Standard primary health care

The treatment may include pharmacological medication, chiropractic and physiotherapy or no active treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Royal Norwegian Ministry of Health

OTHER

Sponsor Role: collaborator

University of Tromso

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunnvald Kvarstein, PhD

Role: PRINCIPAL_INVESTIGATOR

UiT The Arctic University of Tromsø

Locations

University Hospital of North Norway

Tromsø, , Norway

Countries

Norway

Other Identifiers

2014/1652

Identifier Type: -

Identifier Source: org_study_id