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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] 312608 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 334558 0
Condition category
Condition code
Neurological 331162 331162 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 331246 331246 0 0
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] 329134 0
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] 338923 0
Participant perception of short term effects of treatment as compared to other typical episodes without immediate physiotherapy treatment.
Timepoint [1] 338923 0
24-48 hours post intervention.
Primary outcome [2] 338924 0
Participant perceived overall change as compared to other typical episodes of migraine attacks without immediate physiotherapy treatment.
Timepoint [2] 338924 0
24-48 hours post intervention
Primary outcome [3] 339021 0
Participant perception of immediate effects of treatment as compared to other typical episodes without immediate physiotherapy treatment.
Timepoint [3] 339021 0
Immediately post intervention during intervention session and 24-48 hours post intervention
Secondary outcome [1] 437922 0
Duration of migraine attack as compared to other typical episodes without immediate physiotherapy treatment.
Timepoint [1] 437922 0
24-48 hours post intervention.
Secondary outcome [2] 437923 0
Time needed to recover after the migraine attack back to usual function as compared to other typical episodes without immediate physiotherapy treatment.
Timepoint [2] 437923 0
24-48 hours post intervention
Secondary outcome [3] 437924 0
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] 437924 0
24-48 hours post intervention.
Secondary outcome [4] 437925 0
Symptomatic medication use during this episode of migraine attack as compared to other typical episodes without immediate physiotherapy treatment.
Timepoint [4] 437925 0
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?
No
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
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317038 0
University
Name [1] 317038 0
The University of Queensland
Country [1] 317038 0
Australia
Funding source category [2] 317052 0
Charities/Societies/Foundations
Name [2] 317052 0
International Headache Society
Country [2] 317052 0
United Kingdom
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 319299 0
None
Name [1] 319299 0
Address [1] 319299 0
Country [1] 319299 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315794 0
The University of Queensland HABS LNR
Ethics committee address [1] 315794 0
https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics
Ethics committee country [1] 315794 0
Australia
Date submitted for ethics approval [1] 315794 0
Approval date [1] 315794 0
13/10/2022
Ethics approval number [1] 315794 0

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 135814 0
Dr Zhiqi Liang
Address 135814 0
Level 3, Therapies Annexe (84A) The University of Queensland St Lucia QLD 4072, Australia
Country 135814 0
Australia
Phone 135814 0
+61 733654568
Fax 135814 0
Email 135814 0
[email protected]
Contact person for public queries
Name 135815 0
Zhiqi Liang
Address 135815 0
Level 3, Therapies Annexe (84A) The University of Queensland St Lucia QLD 4072, Australia
Country 135815 0
Australia
Phone 135815 0
+61 733654568
Fax 135815 0
Email 135815 0
[email protected]
Contact person for scientific queries
Name 135816 0
Zhiqi Liang
Address 135816 0
Level 3, Therapies Annexe (84A) The University of Queensland St Lucia QLD 4072, Australia
Country 135816 0
Australia
Phone 135816 0
+61 733654568
Fax 135816 0
Email 135816 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
24031Ethical approval    388189-(Uploaded-25-07-2024-11-32-34)-Ethics approval.pdf



Results publications and other study-related documents

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