Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000069459
Ethics application status
Approved
Date submitted
20/12/2024
Date registered
23/01/2025
Date last updated
23/01/2025
Date data sharing statement initially provided
23/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of upper cervical musculoskeletal management on migraine headache in adults
Scientific title
The effect of targeted upper cervical musculoskeletal management on the frequency and burden of migraine headache in adults
Secondary ID [1] 313594 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 336295 0
Primary headache 336138 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332687 332687 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilot study / Clinical trial of a combination of physiotherapy musculoskeletal management strategies focussed on upper cervical rotation on the frequency of migraine. Intervention will include:
-Manual therapy (mobilisation only) to the upper cervical and thoracic region joints .
-Frequency of the intervention- 1 x 1 hour sessions per week for 4 weeks face to face. -Administered by a physiotherapist with over 30 years experience of managing neck pain and headache.
Adherence to the intervention will be monitored by a session attendance checklist and documentation of adherence to self-management strategies at each session.
Intervention code [1] 330192 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340211 0
Global perceived effect
Timepoint [1] 340211 0
T1 immediately post completion of the intervention program T2 3 months post completion of the final treatment session
Primary outcome [2] 340212 0
Craniocervical flexion test
Timepoint [2] 340212 0
T0 baseline T1 immediately post intervention program (final treatment session)
Primary outcome [3] 340210 0
Headache frequency (weekly)
Timepoint [3] 340210 0
T0 baseline (headache frequency over preceding week to study commencement) T1 immediately post intervention program (following final treatment session) T2 3 months from the date of the final treatment
Secondary outcome [1] 443309 0
Headache Impact
Timepoint [1] 443309 0
T0 Baseline T1 immediately post completion of the intervention program T2 3 months from the date of the final treatment
Secondary outcome [2] 443308 0
Weekly headache frequency
Timepoint [2] 443308 0
At each treatment session
Secondary outcome [3] 443310 0
Neck disability
Timepoint [3] 443310 0
T0 Baseline T1 immediately post completion of the intervention program T2 3 months from the date of the final treatment

Eligibility
Key inclusion criteria
Primary headache is migraine, can have other headaches but migraine is main headache
Unilateral headache
At least 8 headaches over the previous 12 weeks
Headache associated with neck pain
Neck symptoms associated with subjective tightness in neck rotation
Migraine can be triggered by neck positioning and or movement
Participant aged 18-65
Need to be available to attend for 4 one hour physiotherapy sessions and a pre- & post- treatment musculoskeletal assessment over the study period: a 4-6 week period. Likely March-April 2025.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
More than 15 headaches (HA) per month
Specific disorders and congenital conditions of the cervical spine (e.g., past cervical spine surgery, infection, tumour, fracture, diffuse idiopathic skeletal hyperostosis, degenerative joint disease, stenosis)
Receiving any manual therapy treatment to neck or head 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 arthropathies, cervical instability, severe osteoporosis, vertigo, dizziness)
Surgery in temporomandibular joint (TMJ) area
Any history of neurological disorders eg. multiple sclerosis, amyotrophic lateral sclerosis (ALS), Parkinson’s, myelopathy, seizures, cervical radiculopathy, herniated disc, thoracic outlet syndrome, brachial plexus neuropathy) and cardiovascular disorders (history of stroke, transient ischemic attacks, stage 2 hypertension, taking anticoagulant medication, syncope, myocardial infarction, haemophilia)
Pregnancy, trying to get pregnant, 3 months post-partum
Active or pending medical litigation, personal injury, workers compensation; disability compensation related to a head or neck injury
Relevant cancer in the past five years.

EXCLUSION CRITERIA PHYSICAL ASSESSMENT
Excluded if no joint signs OR if joint signs at > 3 levels
Excluded if normal range of motion (ROM) on cervical flexion rotation tests (CFRT).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size = 10 participants as this is is a pilot study.
Pre=post change with t- tests if normal distributed and correlations or non-parametric equivalent statistics if non- normalised data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318064 0
University
Name [1] 318064 0
The University of Queensland
Country [1] 318064 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 320417 0
None
Name [1] 320417 0
Address [1] 320417 0
Country [1] 320417 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316714 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 316714 0
Ethics committee country [1] 316714 0
Australia
Date submitted for ethics approval [1] 316714 0
31/01/2022
Approval date [1] 316714 0
27/09/2022
Ethics approval number [1] 316714 0
2021/HE002638

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138762 0
Dr Lucy Thomas
Address 138762 0
School of Health and Rehabilitation Sciences, The University of Queensland, 84a Services Rd, St Lucia, QLD 4072
Country 138762 0
Australia
Phone 138762 0
+61 7 33651644
Fax 138762 0
Email 138762 0
[email protected]
Contact person for public queries
Name 138763 0
Peter Farmer
Address 138763 0
Brisbane Physiotherapy & Rehabilitation 51 Mollison St, West End 4101 Qld
Country 138763 0
Australia
Phone 138763 0
+61 7 377864444
Fax 138763 0
Email 138763 0
[email protected]
Contact person for scientific queries
Name 138764 0
Peter Farmer
Address 138764 0
Brisbane Physiotherapy & Rehabilitation 51 Mollison St, West End 4101 Qld
Country 138764 0
Australia
Phone 138764 0
+61 7 3778 6444
Fax 138764 0
Email 138764 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Pilot trial only



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.