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

NCT02908984 | Active Not Recruiting

• 1 other identifier: 2014/1652
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervicogenic Headache

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

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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

  Baseline

Secondary Outcomes (18)

• Difference in pain intensity after specific neck rehabilitation vs. standard primary health care

  6 months after baseline

• Improved neck function after specific neck rehabilitation vs. standard primary health care

  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

  6 months

• Change in cortical thickness of the brain between patients with unilateral headache and neck pain after specific neck rehabilitation

  6 months

• Differences in white matter integrity in patients with unilateral headache and neck pain vs. healthy controls

  Baseline

Study Arms (2)

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.

Behavioral: Specific neck rehabilitation

Standard primary health care

ACTIVE COMPARATOR

This represents individualized therapy administered by the primary physician.

Other: Standard primary health care

Interventions

Specific neck rehabilitation 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

Specific neck rehabilitation

Standard primary health care OTHER

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

Standard primary health care

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tromso: lead
• The Royal Norwegian Ministry of Health: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, 9019, Norway

Location

MeSH Terms

Conditions

Post-Traumatic Headache; Headache; Neck Pain

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gunnvald Kvarstein, PhD

  UiT The Arctic University of Tromsø

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: September 21, 2016
• Study Start: October 1, 2016
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)