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Trial registered on ANZCTR

Registration number

ACTRN12624000986572

Ethics application status

Approved

Date submitted

25/07/2024

Date registered

13/08/2024

Date last updated

13/08/2024

Date data sharing statement initially provided

13/08/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

The immediate and short term effects of individualised physiotherapy manual therapy treatment for people with migraine during an acute attack

Scientific title

Pilot study on the immediate and short term effects of individualised physiotherapy manual therapy treatment for people with migraine during an acute attack

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Migraine

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All participants will be assessed for any cervical musculoskeletal disorder and heightened pain sensitivity and be provided with individualised physiotherapy treatment by a musculoskeletal physiotherapist experienced in treating patients with headaches and heightened pain sensitivity. All participants will be educated on how to recognise when they are in the prodromal phase (up to 24 hours before a migraine attack) and to contact the treating physiotherapist when they are in the prodromal phase. Education will be delivered face-to-face with the physiotherapist over about 10 minutes with the help of visual aids in interactive discussions with each participant to allow questions and confirmation of understanding. No booklets will be provided. When contacted by the participant, the physiotherapist will confirm that they are within the prodromal period through discussion of their symptom presentation. Treatment will be provided as soon as possible from the beginning of the prodromal phase, or up to 4 hours into the migraine attack. The duration of the intervention period will be up till the end of the study: 17th September 2024.

One session of treatment will be performed in person, face to face at the university clinic, for each prodromal period. There are no maximum number of sessions over the intervention period. All participants will be provided individualised treatment that consists of manual therapy techniques such as spinal mobilisations, manipulation and gentle soft tissue techniques, all aiming at reducing current pain levels and any associated symptoms. Treatment will be personalised at the discretion of the treating physiotherapist according to the individual’s presenting condition, response to pain relieving techniques and their personal preferences.

All participants will be contacted at the end of the study to confirm if treatment was sought and attended for all prodromal periods during the study period. All sessions attended will be recorded electronically with treatment notes.

Intervention code [1]

Treatment: Other

Comparator / control treatment

No control group, all participants will be provided the same treatment and response to treatment will be compared to other migraine attacks when no immediate physiotherapy treatment was received.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Participant perception of short term effects of treatment as compared to other typical episodes without immediate physiotherapy treatment.

Timepoint [1]

24-48 hours post intervention.

Primary outcome [2]

Participant perceived overall change as compared to other typical episodes of migraine attacks without immediate physiotherapy treatment.

Timepoint [2]

24-48 hours post intervention

Primary outcome [3]

Participant perception of immediate effects of treatment as compared to other typical episodes without immediate physiotherapy treatment.

Timepoint [3]

Immediately post intervention during intervention session and 24-48 hours post intervention

Secondary outcome [1]

Duration of migraine attack as compared to other typical episodes without immediate physiotherapy treatment.

Timepoint [1]

24-48 hours post intervention.

Secondary outcome [2]

Time needed to recover after the migraine attack back to usual function as compared to other typical episodes without immediate physiotherapy treatment.

Timepoint [2]

24-48 hours post intervention

Secondary outcome [3]

Intensity of symptoms (headache and any other associated symptoms) during this episode of migraine attack as compared to other typical episodes without immediate physiotherapy treatment.

Timepoint [3]

24-48 hours post intervention.

Secondary outcome [4]

Symptomatic medication use during this episode of migraine attack as compared to other typical episodes without immediate physiotherapy treatment.

Timepoint [4]

24-48 hours post intervention

Eligibility

Key inclusion criteria

- Classified as low frequency episodic migraine (8 or less days of headache/month) according to ICHD-3 criteria.
- Experiencing or about to experience migraine attack and able to attend university clinic for treatment just prior to onset of attack (up to 24 hours prior) and up to 4 hours after the onset of the migraine attack.

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Presentation of current episode of headache, as reported by the participant, does not fit ICHD-3 classification criteria for migraine.

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

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

16/08/2024

Actual

Date of last participant enrolment

Anticipated

17/09/2024

Actual

Date of last data collection

Anticipated

20/09/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Queensland

Address [1]

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

International Headache Society

Address [2]

Country [2]

United Kingdom

Primary sponsor type

University

Name

The University of Queensland

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland HABS LNR

Ethics committee address [1]

https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/10/2022

Ethics approval number [1]

Summary

Brief summary

This pilot study will explore the immediate and short term effects of individualised physiotherapy manual therapy treatment during the prodromal phase or beginning (up to 4 hours) of a migraine attack episode. Our hypothesis is that delivery of individualised physiotherapy manual therapy treatment in this period will help to reduce symptoms and burden of the single migraine attack in the immediate and short term.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Zhiqi Liang

Address

Level 3, Therapies Annexe (84A) The University of Queensland St Lucia QLD 4072, Australia

Country

Australia

Phone

+61 733654568

Fax

[email protected]

Contact person for public queries

Name

Zhiqi Liang

Address

Level 3, Therapies Annexe (84A) The University of Queensland St Lucia QLD 4072, Australia

Country

Australia

Phone

+61 733654568

Fax

[email protected]

Contact person for scientific queries

Name

Zhiqi Liang

Address

Level 3, Therapies Annexe (84A) The University of Queensland St Lucia QLD 4072, Australia

Country

Australia

Phone

+61 733654568

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24031	Ethical approval					388189-(Uploaded-25-07-2024-11-32-34)-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.

Trial Review

Documents added manually

Documents added automatically