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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.
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Scientific title
Individualised physiotherapy management of persons with migraine and neck pain: a feasibility study.
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Secondary ID [1]
311708
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Migraine
333181
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Musculoskeletal neck disorder
333182
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Condition category
Condition code
Neurological
329870
329870
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0
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Other neurological disorders
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Physical Medicine / Rehabilitation
329871
329871
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0
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Physiotherapy
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Musculoskeletal
329872
329872
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328170
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Rehabilitation
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Intervention code [2]
328710
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
338327
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Semi-structured interviews conducted one-on-one, in person or via teleconferencing, with a member of the research team not involved in provision of intervention.
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Timepoint [1]
338327
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Baseline, within 1 month post-intervention
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Primary outcome [2]
338328
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Physiotherapist acceptability: composite outcome based on interview and questionnaire responses.
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Assessment method [2]
338328
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The physiotherapist will complete the validated AIM-IAM-FIM questionnaire on acceptability, appropriateness and feasibility of the treatment program. The treating physiotherapist will be one-on-one, in person or via teleconferencing, interviewed for their perspective on acceptability of the treatment program, guided by and exploring the reasons underlying their responses to the questionnaire.
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Timepoint [2]
338328
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Within 1 month post-intervention.
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Primary outcome [3]
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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.
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Assessment method [3]
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Recruitment rate (number of registrants and percentage of eligible participants who enrol over recruitment period), proportions of eligible participants in each subgroup (percentage number of participants in each subgroup), attendance rate (from session and re-bookings records), data completion rate (from collation of complete and incomplete survey entries) will be collected. Detailed records of recruitment and session bookings will be kept and audited at the end of the study to obtain this data. Participants will also be interviewed on their experience in participation.
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Timepoint [3]
338329
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Interview to be held within 1 month post intervention. Other data after final data collection 6 months post intervention
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Secondary outcome [1]
435439
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Safety
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Assessment method [1]
435439
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Safety will be assessed through adverse events: extent and duration of symptoms and or decrease in functional ability during the intervention period. Day to day fluctuations in any symptoms and functional levels will be recorded on the electronic diary. Adverse events will be recorded and rated on severity using the standardised Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 classification. Increase in symptoms (e.g., headache or neck pain) without any intervention required will be rated as Grade 1. Migraine attacks or any other events limiting daily activities and or requiring local or non-invasive intervention will be rated Grade 2. Severe or medically significant events will be rated Grade 3 and above. Participants will also be interviewed one-on-one, in person or via teleconferencing, on their perspectives on their definition of adverse events, including risk tolerance to aggravation of symptoms.
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Timepoint [1]
435439
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Throughout the intervention period (0-6 weeks) Interview of participants within 1 month post intervention
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Secondary outcome [2]
435440
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Description of individualised treatment programs for the four subgroups of individuals with migraine and neck pain
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Assessment method [2]
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The treating therapist and participants will be interviewed one-on one, in person or via teleconferencing, for their perspectives on if and how the treatment programs were individualised. Qualitative content analysis of video recordings of treatment sessions will also be used together with interview findings to describe intervention.
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Timepoint [2]
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Within 1 month post-intervention
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Secondary outcome [3]
435441
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The Global Rating of Change (GRoC) Scale will also be applied to neck pain and or migraine as identified by each participant.
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Assessment method [3]
435441
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GRoC Scale
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Timepoint [3]
435441
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Post-intervention (6 weeks), 3-month follow up (18 weeks), 6-month follow up
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Secondary outcome [4]
435442
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Headache frequency
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Assessment method [4]
435442
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Electronic diary, number of headache days over one month
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Timepoint [4]
435442
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Baseline, Post-intervention (6 weeks), 3-month follow up (18 weeks)
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Secondary outcome [5]
435443
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Headache Disability
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Assessment method [5]
435443
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Headache Impact Test (HIT-6)
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Timepoint [5]
435443
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Baseline, Post-intervention (6 weeks), 3-month follow up (18 weeks), 6-month follow up
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Secondary outcome [6]
435444
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Headache Intensity
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Assessment method [6]
435444
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Average headache intensity on a 0 to 10 numeric rating scale where 0=no pain, and 100=worst pain
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Timepoint [6]
435444
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Baseline, Post-intervention (6 weeks), 3-month follow up (18 weeks), 6-month follow up
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Secondary outcome [7]
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Neck Pain Disability
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Assessment method [7]
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Neck Disability Index (NDI)
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Timepoint [7]
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Baseline, Post-intervention (6 weeks), 3-month follow up (18 weeks), 6-month follow up
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Secondary outcome [8]
435446
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Cervical range of motion
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Assessment method [8]
435446
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Maximal range of motion in sagittal and transverse planes (degrees), measured using CROM
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Timepoint [8]
435446
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Baseline, Post-intervention (6 weeks)
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Secondary outcome [9]
435447
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Cervical flexor muscle endurance
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Assessment method [9]
435447
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Head lift test, duration (secs) of position held
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Timepoint [9]
435447
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Baseline, Post-intervention (6 weeks)
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Secondary outcome [10]
435448
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Symptomatic joint signs
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Assessment method [10]
435448
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PAIVMs and PPIVMs of the cervical segments C01-C7T1. Participant reported local or referred pain to head, assessor perceived passive range of motion and tissue resistance to palpation.
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Timepoint [10]
435448
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Baseline, Post-intervention (6 weeks)
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Secondary outcome [11]
435449
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Pressure pain thresholds
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Assessment method [11]
435449
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PPTs of the temporalis and tibialis anterior using the Somedic AB handheld pressure algometer (Sollentuna, Sweden) with a 1cm2 probe
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Timepoint [11]
435449
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Baseline, Post-intervention (6 weeks)
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Secondary outcome [12]
435450
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Wind-up ratio
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Assessment method [12]
435450
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Using the MRC Systems GmbH (Heidelberg, Germany) 256mN PinPrick stimulator, a single stimulus will be applied to the temporalis and participants will be asked to rate their level of pain on a numeral rating scale from 0 to 100, with 0 being ‘no pain’ and 100 being the ‘worst imaginable pain’. A series of ten repeated pinpricks will next be applied to the same area and participants asked to rate their pain after the application of the tenth stimulus. The ratio between the rating for a single stimulus and the series of ten will be calculated as the wind-up ratio.
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Timepoint [12]
435450
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Baseline, Post-intervention (6 weeks)
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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
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
17/06/2024
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Actual
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Date of last participant enrolment
Anticipated
22/07/2024
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Actual
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Date of last data collection
Anticipated
31/03/2025
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
316592
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Charities/Societies/Foundations
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Name [1]
316592
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International Headache Society
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Address [1]
316592
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Country [1]
316592
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United Kingdom
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Funding source category [2]
316593
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University
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Name [2]
316593
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University of Queensland
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Address [2]
316593
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Country [2]
316593
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Australia
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Primary sponsor type
University
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Name
University of Queensland
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Address
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Country
Australia
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Secondary sponsor category [1]
318773
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None
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Name [1]
318773
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Address [1]
318773
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Country [1]
318773
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314859
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The University of Queensland HABS LNR
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Ethics committee address [1]
314859
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https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics
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Ethics committee country [1]
314859
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Australia
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Date submitted for ethics approval [1]
314859
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Approval date [1]
314859
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13/10/2022
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Ethics approval number [1]
314859
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2021/HE002638
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Zhiqi Liang
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Address
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Level 3, Therapies Annexe (84A) The University of Queensland St Lucia QLD 4072, Australia
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Country
132958
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Australia
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Phone
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+61 0733654568
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Fax
132958
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Email
132958
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[email protected]
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Contact person for public queries
Name
132959
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Zhiqi Liang
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Address
132959
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Level 3, Therapies Annexe (84A) The University of Queensland St Lucia QLD 4072, Australia
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Country
132959
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Australia
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Phone
132959
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+61 0733654568
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Fax
132959
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Email
132959
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[email protected]
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Contact person for scientific queries
Name
132960
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Zhiqi Liang
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Address
132960
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Level 3, Therapies Annexe (84A) The University of Queensland St Lucia QLD 4072, Australia
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Country
132960
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Australia
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Phone
132960
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+61 0733654568
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Fax
132960
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Email
132960
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23775
Ethical 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
No additional documents have been identified.
Download to PDF