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Trial registered on ANZCTR


Registration number
ACTRN12624000717550
Ethics application status
Approved
Date submitted
24/05/2024
Date registered
11/06/2024
Date last updated
11/06/2024
Date data sharing statement initially provided
11/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Individualised physiotherapy management of persons with migraine and neck pain: a feasibility study.
Scientific title
Individualised physiotherapy management of persons with migraine and neck pain: a feasibility study.
Secondary ID [1] 311708 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 333181 0
Musculoskeletal neck disorder 333182 0
Condition category
Condition code
Neurological 329870 329870 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 329871 329871 0 0
Physiotherapy
Musculoskeletal 329872 329872 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be assessed for any cervical musculoskeletal disorder and heightened pain sensitivity (generalized or in the neck) at the start of the trial to guide physiotherapy treatment. All participants will be provided with individualised physiotherapy treatments over six weeks, in 6 to 8 physiotherapy sessions of 45 minutes duration each, by a musculoskeletal physiotherapist experienced in treating patients with headaches and heightened pain sensitivity.

Treatments will be personalised according to the individual’s condition (with or without cervical musculoskeletal disorder and/or pain hypersensitivity). The time spent performing manual therapy, exercise, or pain science education will be adapted for each patient at each session, according to the physiotherapist’s evaluation, patient’s preference, and headache phase.

All participants will be offered pain science education and aerobic exercise prescription (e.g., walking, cycling or running program). Additional treatments will be provided to some subgroups:
a) Participants with cervical musculoskeletal dysfunction will be offered specific neck treatments including manual therapy (e.g., joint mobilisations), motor control and strength exercises for cervical and axioscapular muscles and proprioceptive exercises as indicated aimed at addressing pain and the identified cervical impairments.
b) If pain hypersensitivity is also detected, the type of treatment, dosage and frequency, will be tailored on each occasion by the treating physiotherapist with input from the participant. For example, if the individual is treated during an ictal phase, manual therapy techniques may be applied more gently, in an altered direction that feels most comfortable for the participant (i.e. aiming at decreasing headache).
c) If only pain hypersensitivity and no cervical musculoskeletal dysfunction is detected in the participant, physiotherapy treatment will focus mainly on pain science education and aerobic exercise prescription, with manual therapy intervention aimed at improving the tolerance of the pain system.
d) If neither cervical musculoskeletal dysfunction nor pain hypersensitivity is detected in the participant, physiotherapy treatment will only consist of pain science education and aerobic exercise prescription.

Pain science education will be delivered face-to-face with the physiotherapist with the help of visual aids in interactive discussions with each participant to allow questions. It will be tailored to the individual participant’s needs and beliefs about pain to include explanations about pain, factors influencing pain perception such as the cognitive aspects, and how to use the information to better manage migraine.

At each treatment session, the physiotherapist will assess for changes in clinical condition and progress or modify interventions as indicated. Individualised self-management plans will also be provided at the end of the intervention period. Attendance rate and participant self-reports of compliance to home exercises will be used to assess adherence to intervention.
Intervention code [1] 328170 0
Rehabilitation
Intervention code [2] 328710 0
Treatment: Other
Comparator / control treatment
Participants with neither cervical musculoskeletal dysfunction nor pain hypersensitivity will be treated with only pain science education and aerobic exercise prescription. No manual therapy or neck exercises will be provided.
Control group
Active

Outcomes
Primary outcome [1] 338327 0
Consumer acceptability. Findings from our previous qualitative study indicated that individuals with migraine and neck pain had different goals when seeking neck treatments. For example, some individuals want temporary neck pain relief whereas some want long term neck pain improvements and others expect reductions in migraine attack frequency. Therefore, treatment outcomes cannot be generalised across the population. As such, the primary outcome of this feasibility case series is to examine what aspects and to what extent participants’ expectations are met by the individualised neck treatment program. Semi-structured interviews will be conducted before the intervention to establish each individual participant’s expectations of the intervention and effects on their condition. Following the intervention, semi-structured interviews will be conducted again to understand participants’ experiences of the intervention, the aspects and extent of which their expectations were or were not met.
Timepoint [1] 338327 0
Baseline, within 1 month post-intervention
Primary outcome [2] 338328 0
Physiotherapist acceptability: composite outcome based on interview and questionnaire responses.
Timepoint [2] 338328 0
Within 1 month post-intervention.
Primary outcome [3] 338329 0
Feasibility of treatment program will be assessed as a composite outcome, including success rate and barriers to implementation of individualised management, compliance with interventions and participant acceptance of the study process.
Timepoint [3] 338329 0
Interview to be held within 1 month post intervention. Other data after final data collection 6 months post intervention
Secondary outcome [1] 435439 0
Safety
Timepoint [1] 435439 0
Throughout the intervention period (0-6 weeks) Interview of participants within 1 month post intervention
Secondary outcome [2] 435440 0
Description of individualised treatment programs for the four subgroups of individuals with migraine and neck pain
Timepoint [2] 435440 0
Within 1 month post-intervention
Secondary outcome [3] 435441 0
The Global Rating of Change (GRoC) Scale will also be applied to neck pain and or migraine as identified by each participant.
Timepoint [3] 435441 0
Post-intervention (6 weeks), 3-month follow up (18 weeks), 6-month follow up
Secondary outcome [4] 435442 0
Headache frequency
Timepoint [4] 435442 0
Baseline, Post-intervention (6 weeks), 3-month follow up (18 weeks)
Secondary outcome [5] 435443 0
Headache Disability
Timepoint [5] 435443 0
Baseline, Post-intervention (6 weeks), 3-month follow up (18 weeks), 6-month follow up
Secondary outcome [6] 435444 0
Headache Intensity
Timepoint [6] 435444 0
Baseline, Post-intervention (6 weeks), 3-month follow up (18 weeks), 6-month follow up
Secondary outcome [7] 435445 0
Neck Pain Disability
Timepoint [7] 435445 0
Baseline, Post-intervention (6 weeks), 3-month follow up (18 weeks), 6-month follow up
Secondary outcome [8] 435446 0
Cervical range of motion
Timepoint [8] 435446 0
Baseline, Post-intervention (6 weeks)
Secondary outcome [9] 435447 0
Cervical flexor muscle endurance
Timepoint [9] 435447 0
Baseline, Post-intervention (6 weeks)
Secondary outcome [10] 435448 0
Symptomatic joint signs
Timepoint [10] 435448 0
Baseline, Post-intervention (6 weeks)
Secondary outcome [11] 435449 0
Pressure pain thresholds
Timepoint [11] 435449 0
Baseline, Post-intervention (6 weeks)
Secondary outcome [12] 435450 0
Wind-up ratio
Timepoint [12] 435450 0
Baseline, Post-intervention (6 weeks)

Eligibility
Key inclusion criteria
- Adults 18-60 years old
- Classified with Migraine (ICHD-3 criteria) as main headache if more than 1 type of headache
- At least 2 migraine attacks per month over the past 3 months
- Neck pain present (in any phase of the migraine cycle)
- No change to preventative management over the past month and no plans to change in the next 3 months
- Willing to undergo baseline and post-intervention assessments, have treatment as allocated, and attend follow-ups and complete headache diaries and questionnaires
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current or recent (within last 3 months) physiotherapy/osteopathic/chiropractic management
- Conditions with general hypersensitisation such as Fibromyalgia, Chronic Fatigue Syndrome, Long Covid Syndrome

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
22/07/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 316592 0
Charities/Societies/Foundations
Name [1] 316592 0
International Headache Society
Country [1] 316592 0
United Kingdom
Funding source category [2] 316593 0
University
Name [2] 316593 0
University of Queensland
Country [2] 316593 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 318773 0
None
Name [1] 318773 0
Address [1] 318773 0
Country [1] 318773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314859 0
The University of Queensland HABS LNR
Ethics committee address [1] 314859 0
https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics
Ethics committee country [1] 314859 0
Australia
Date submitted for ethics approval [1] 314859 0
Approval date [1] 314859 0
13/10/2022
Ethics approval number [1] 314859 0
2021/HE002638

Summary
Brief summary
Previous trials have treated individuals with migraine associated neck pain as homogenous. However our research identified cervical musculoskeletal dysfunction in about 40% and pain hypersensitivity in about 50% of participants with migraine. This indicates the presence of four subgroups in this population: i) with cervical musculoskeletal dysfunction and pain hypersensitivity, ii) only cervical musculoskeletal dysfunction, iii) only pain hypersensitivity, iv) neither. We hypothesise that physiotherapy intervention should therefore be individualised according to these subgroups but such individualisation of management is novel in this population. Therefore the primary aim of this study is to establish the feasibility of conducting an efficacy trial on individualised physiotherapy management of patients with migraine and neck pain, including patient perspectives on preferred primary outcomes and meaningful effect sizes. The secondary aims are to describe this novel individualised treatment program and explore the effects and possible underlying mechanisms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132958 0
Dr Zhiqi Liang
Address 132958 0
Level 3, Therapies Annexe (84A) The University of Queensland St Lucia QLD 4072, Australia
Country 132958 0
Australia
Phone 132958 0
+61 0733654568
Fax 132958 0
Email 132958 0
[email protected]
Contact person for public queries
Name 132959 0
Zhiqi Liang
Address 132959 0
Level 3, Therapies Annexe (84A) The University of Queensland St Lucia QLD 4072, Australia
Country 132959 0
Australia
Phone 132959 0
+61 0733654568
Fax 132959 0
Email 132959 0
[email protected]
Contact person for scientific queries
Name 132960 0
Zhiqi Liang
Address 132960 0
Level 3, Therapies Annexe (84A) The University of Queensland St Lucia QLD 4072, Australia
Country 132960 0
Australia
Phone 132960 0
+61 0733654568
Fax 132960 0
Email 132960 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23775Ethical approval    387475-(Uploaded-24-05-2024-07-52-10)-Ethics approval.pdf



Results publications and other study-related documents

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

Documents added automatically
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