None listed
Conditions
Brief summary
Neck pain is an important issue in primary headache with recent research suggests up to 40% of patients demonstrate signs of cervical musculoskeletal dysfunction. The clinical trial will use assessments prior to 4 weeks of treatment as usual, Day 1 of the 4 week treatment period, Day 1 post treatment and 3 / 6* and 12* months post treatment (*= 6 and 12 month post treatment assessments will only be completed if results at earlier timepoints indicate continued analysis is warranted) to examine whether multimodal physiotherapy targeted (manual therapy, exercises and education) influences frequency, severity, functional impact and characteristics of migraine events with neck pain and identified upper cervical rotation impairment. A second study will be an embedded pilot study with a minimum of 10 additional participants in individuals with no identified cervical upper cervical rotation impairment. We hypothesise that cervical treatment is more relevant and effective in the participants with identified cervical dysfunction. A third study involves interviews to explore patient experiences and opinions on the interventions 3 months following the completion of the treatment period.
Interventions
Mixed methods (Interventional study and interviews)
The interventional component is a clinical trial with a within-subject repeated measures design investigating physiotherapy musculoskeletal management strategies focussed on upper cervical rotation on the frequency and burden of migraine.
Participants in the interventional trial will be stratified into two cohorts based on the presence or absence of identifiable cervical musculoskeletal dysfunction:
• Cohort A (main study group): Participants w
Mixed methods (Interventional study and interviews) The interventional component is a clinical trial with a within-subject repeated measures design investigating physiotherapy musculoskeletal management strategies focussed on upper cervical rotation on the frequency and burden of migraine. Participants in the interventional trial will be stratified into two cohorts based on the presence or absence of identifiable cervical musculoskeletal dysfunction: • Cohort A (main study group): Participants with identified cervical musculoskeletal dysfunction • Cohort B (embedded pilot study): Participants without identifiable cervical musculoskeletal dysfunction will receive the same interventions as Cohort A to provide preliminary evidence regarding the relevance of the physical assessment process in patient screening The intervention will be multimodal physiotherapy management (manual therapy mobilisation techniques, related home exercises and education). The same treatment process will be provided by a physiotherapist with over 30 years experience to each participant who will receive 4 x 1 hour individual physiotherapy sessions (1 per week for 4 weeks) at a private physiotherapy practice. Due to variability in participants initial status, symptoms and irritability the dosage of manual therapy and exercises, and pace of progression, will be determined by the treating physiotherapy. The manual therapy will take 30-40 minutes with 10 minutes each of exercise and education. The exercises involve range of movement and self 'mobilisation with movement' techniques for the neck and cervicothoracic area combined with postural exercises. The clinic appointments will be scheduled to suit the participants availability and there are reminders for home exercises as part of a daily diary that will be used to collect data. • An embedded qualitative sub-study will be conducted using interviews at approximately 3 months post-treatment of participants from both Cohort A & B.
Sponsors
The University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Unilateral migraine as the dominant headache consistent with the ICHD-3 migraine criteria • Headache frequency of at least 4 days per month (but not more than 15) • A history of regular neck pain Physical examination inclusion criteria: • Arm 1 (Cohort A) require unilateral C1/2 segmental movement dysfunction identified on physical assessment with abnormal Cervical Flexion Rotation Test (CFRT) and C1/2 positive joint palpation Arm 2 (Cohort B) need to have no identified cervical segmental movement dysfunction with a normal CFRT.
Exclusion criteria
• A maximum number of 15 headache days per month • Specific disorders and congenital conditions of the cervical spine (e.g., past cervical spine surgery, infection, tumour, fracture, diffuse idiopathic skeletal hyperostosis, cervical degenerative joint disease, stenosis) • Receiving any manual therapy treatment to the neck or head in the past 3 months • A change in migraine medication in the past 3 months • Neck and head trauma requiring medical care/hospitalisation in the past 3 months • Contraindications to study treatments (e.g., inflammatory cervical arthropathies, cervical instability, severe osteoporosis, vertigo, dizziness) • Surgery in Temporomandibular joint (TMJ) area in past 6 months • A neurological history with current symptoms (multiple sclerosis, Amyotrophic lateral sclerosis (ALS), Parkinson’s, myelopathy, seizures, cervical radiculopathy, herniated disc, thoracic outlet syndrome, brachial plexus neuropathy) • A cardiovascular history with current symptoms (history of stroke, transient ischaemic attacks, stage 2 hypertension, taking anticoagulant medication, syncope, myocardial infarction, haemophilia) • Pregnancy, trying to get pregnant, or within 3 months postpartum • Active or pending medical litigation, personal injury, workers compensation, or disability compensation related to a head or neck injury • Cancer in the past five years On physical examination: • hyperalgesia at > 3 cervical levels on a passive accessory manual examination (as this could indicate central sensitisation processes were a dominant component). • Test positive to Vertebrobasilar insufficiency (VBI) screening which is a safety concern for the vertebral artery during upper cervical rotation to ensure end of range positions do not provoke symptoms of cerebral ischaemia.
Outcome results
None listed