ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Migraine

Musculoskeletal neck disorder

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

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]

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.

Assessment method [1]

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.

Timepoint [1]

Baseline, within 1 month post-intervention

Primary outcome [2]

Physiotherapist acceptability: composite outcome based on interview and questionnaire responses.

Assessment method [2]

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.

Timepoint [2]

Within 1 month post-intervention.

Primary outcome [3]

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.

Assessment method [3]

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.

Timepoint [3]

Interview to be held within 1 month post intervention. Other data after final data collection 6 months post intervention

Secondary outcome [1]

Safety

Assessment method [1]

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.

Timepoint [1]

Throughout the intervention period (0-6 weeks) Interview of participants within 1 month post intervention

Secondary outcome [2]

Description of individualised treatment programs for the four subgroups of individuals with migraine and neck pain

Assessment method [2]

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.

Timepoint [2]

Within 1 month post-intervention

Secondary outcome [3]

The Global Rating of Change (GRoC) Scale will also be applied to neck pain and or migraine as identified by each participant.

Assessment method [3]

GRoC Scale

Timepoint [3]

Post-intervention (6 weeks), 3-month follow up (18 weeks), 6-month follow up

Secondary outcome [4]

Headache frequency

Assessment method [4]

Electronic diary, number of headache days over one month

Timepoint [4]

Baseline, Post-intervention (6 weeks), 3-month follow up (18 weeks)

Secondary outcome [5]

Headache Disability

Assessment method [5]

Headache Impact Test (HIT-6)

Timepoint [5]

Baseline, Post-intervention (6 weeks), 3-month follow up (18 weeks), 6-month follow up

Secondary outcome [6]

Headache Intensity

Assessment method [6]

Average headache intensity on a 0 to 10 numeric rating scale where 0=no pain, and 100=worst pain

Timepoint [6]

Baseline, Post-intervention (6 weeks), 3-month follow up (18 weeks), 6-month follow up

Secondary outcome [7]

Neck Pain Disability

Assessment method [7]

Neck Disability Index (NDI)

Timepoint [7]

Baseline, Post-intervention (6 weeks), 3-month follow up (18 weeks), 6-month follow up

Secondary outcome [8]

Cervical range of motion

Assessment method [8]

Maximal range of motion in sagittal and transverse planes (degrees), measured using CROM

Timepoint [8]