Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000091606
Ethics application status
Approved
Date submitted
21/01/2014
Date registered
23/01/2014
Date last updated
24/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeting pain mechanisms from the 'top-down' and the 'bottom-up' in chronic tension-type headache
Scientific title
An investigation of non-invasive brain and spinal cord stimulation versus brain stimulation (with sham spinal cord stimulation), and spinal cord stimulation (with sham brain stimulation) in people with chronic tension-type headache to evaluate feasibility, safety and effect on chronic tension type headache intensity, frequency and duration.
Secondary ID [1] 283932 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic tension-type headache 290951 0
Condition category
Condition code
Musculoskeletal 291297 291297 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive 30 minutes of combined active transcranial direct current stimulation (tDCS) and active transspinal direct current stimulation (tsDCS) for five consecutive daily sessions.

Transcranial direct current stimulation (tDCS): will be delivered using a direct current stimulator via two 35 cm2 surface sponge electrodes. The active electrode (anode) will be placed over the primary motor cortex and the reference electrode (cathode) over the contralateral supraorbital region. Current intensity will be ramped up (0 mA to 1 mA) and down (1 mA to 0 mA) over 10 s at the beginning and end of the stimulation period.

Transspinal direct current stimulation (tsDCS): will be delivered using a direct current stimulator via two 35 cm2 surface sponge electrodes. The active electrode (anode) will be positioned over the thoracic spinal cord at the tenth thoracic vertebra and the reference electrode (cathode) above the right shoulder. Current intensity will be ramped up (0 mA to 1 mA) and down (1 mA to 0 mA) over 10 s at the beginning and end of the stimulation period.
Intervention code [1] 288627 0
Rehabilitation
Intervention code [2] 288628 0
Treatment: Devices
Comparator / control treatment
1. Participants will receive 30 minutes of combined active transspinal direct current stimulation (tsDCS) and sham transcranial direct current stimulation (tDCS) for five consecutive daily sessions.

Transspinal direct current stimulation (tsDCS): will be delivered using a direct current stimulator via two 35 cm2 surface sponge electrodes. The active electrode (anode) will be positioned over the thoracic spinal cord at the tenth thoracic vertebra and the reference electrode (cathode) above the right shoulder. Current intensity will be ramped up (0 mA to 1 mA) and down (1 mA to 0 mA) over 10 s at the beginning and end of the stimulation period.

Sham transcranial direct current stimulation (tDCS): will be delivered with electrodes placed in an identical position to that used for active tDCS. Stimulation will be turned on for 15 s and then off. This is a standard sham approach in tDCS studies which ensures that participants feel the initial tingling sensation associated with tDCS. The tDCS unit will be placed out of sight for both active and sham interventions.


***

2. Participants will receive 30 minutes of combined sham transspinal direct current stimulation (tsDCS) and active transcranial direct current stimulation (tDCS) for five consecutive daily sessions.

Sham transspinal direct current stimulation (tsDCS): will be delivered with electrodes placed in an identical position to that used for active tsDCS. Stimulation will be turned on for 15 s and then off. This is a standard sham approach in tsDCS studies which ensures that participants feel the initial tingling sensation associated with tsDCS.

Transcranial direct current stimulation (tDCS): will be delivered using a direct current stimulator via two 35 cm2 surface sponge electrodes. The active electrode (anode) will be placed over the primary motor cortex and the reference electrode (cathode) over the contralateral supraorbital region. Current intensity will be ramped up (0 mA to 1 mA) and down (1 mA to 0 mA) over 10 s at the beginning and end of the stimulation period.
Control group
Active

Outcomes
Primary outcome [1] 291293 0
Perceived response to therapy will be assessed using a 7 point Likert scale ranging from completely recovered to vastly worsened (Global Perceived Effect Scale (GPES)).
Timepoint [1] 291293 0
Assessed at baseline and immediately following the 5-treatment intervention.
Primary outcome [2] 291294 0
Headache intensity, frequency, duration and use of analgesics: Headache intensity will be recorded on a 10 cm visual analogue scale (VAS) with 'no pain' at zero and 'worst pain imaginable' at 10, headache duration as hours per day, frequency as the number of days with headache per month, and use of analgesics as the number of doses.
Timepoint [2] 291294 0
Assessed immediately before treatment and immediately after treatment over a 4-week period using responses to a daily, automated SMS system.
Primary outcome [3] 291334 0
Safety and adverse events: data on any side effects or adverse events (such as headache, nausea, dizziness) will be recorded.
Timepoint [3] 291334 0
Assessed at baseline and immediately following the 5-treatment intervention.
Secondary outcome [1] 306437 0
Central pain modulation (CPM): CPM is tested as a change in the pain perceived in one body region [electrical stimulation, 4 ms pulse duration, applied to the left upper arm] as a result of pain induced in another [heat pain, 30 pulses/minute to 1 degree C above pain threshold via thermode, applied to the right forearm]. Twenty heat pain stimuli will be delivered to the left arm alone followed by 20 combined with electrical pain stimulation to the right arm.
Timepoint [1] 306437 0
Assessed at baseline and immediately following the 5-treatment intervention.
Secondary outcome [2] 306438 0
Pressure (PPT) and cold pain thresholds (CPT): PPT will be measured using a pressure algometer [probe size of 1 cm2, application rate 40 kPa/s]. CPT will be measured using the Thermotest system [preset to 30 degree C, temperature change rate of 1.8 degree C/s]. Participants will push a button when the pressure or cold sensation first becomes painful. The average of three recordings will be analysed at each of six sites: bilateral temporal muscle, bilateral upper trapezius muscle and bilateral thumbnail.
Timepoint [2] 306438 0
Assessed at baseline and immediately following the 5-treatment intervention.
Secondary outcome [3] 306439 0
Nociceptive flexor withdrawal reflex (NFR): Surface stimulating electrodes will be positioned at a retromalleolar location along the right sural nerve. Recording electrodes will be positioned over the belly of the biceps femoris muscle. Stimulation will consist of pulse trains of 20 ms duration at an interval frequency of 300 Hz. The intensity needed to evoke a response in the biceps femoris muscles, indicating activation of the NFR, and the subjective pain threshold will be recorded.
Timepoint [3] 306439 0
Assessed at baseline and immediately following the 5-treatment intervention.

Eligibility
Key inclusion criteria
Participants with a diagnosis of chronic tension-type headache (CCTH) according to the international Classification of Headache Disorders, 2nd edition (ICHD-II) criteria will be recruited. Additional inclusion criteria will comprise: i) diagnosis of CTTH for greater than 12 months prior to commencing the trial, ii) experience painful episodes on 15 or more days per month, iii) experience painful episodes that last more than 4 hours when untreated, and iv) experienced symptom onset before age 50 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals under 18 years or who present with neurological or psychiatric conditions or use of prophylactic migraine drugs will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Off-site concealed randomisation will be prepared by a researcher using a computer generated random number sequence. Consecutively numbered, randomly ordered opaque envelopes containing group allocation will be opened consecutively by the therapist implementing the types of intervention. The person recruiting thus will not know to which group the subject will be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number will be used to generate the sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a proof of concept study designed to generate data that can be used to inform a future large randomised controlled trial should the intervention appear feasible, safe and show effectiveness. We have selected a sample size of 10 individuals per group, or 30 participants in total.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2014
Actual
9/06/2014
Date of last participant enrolment
Anticipated
Actual
1/10/2014
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
30
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288575 0
University
Name [1] 288575 0
University of Western Sydney
Country [1] 288575 0
Australia
Primary sponsor type
Individual
Name
Dr Siobhan Schabrun
Address
University of Western Sydney, Campbelltown Campus, Locked Bag 1797, Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 287293 0
Individual
Name [1] 287293 0
Julia Treleaven
Address [1] 287293 0
University of Queensland, School of Health and Rehabilitation Science, Therapies Annex, Building 84a, St Lucia QLD 4072
Country [1] 287293 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290438 0
Human Research Ethics Committee, University of Western Sydney
Ethics committee address [1] 290438 0
Ethics committee country [1] 290438 0
Australia
Date submitted for ethics approval [1] 290438 0
Approval date [1] 290438 0
30/05/2013
Ethics approval number [1] 290438 0
H10184

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45686 0
Dr Siobhan Schabrun
Address 45686 0
University of Western Sydney, Campbelltown Campus, Locked Bag 1797, Penrith NSW 2751
Country 45686 0
Australia
Phone 45686 0
+61 2 4620 3497
Fax 45686 0
+61 2 4620 3792
Email 45686 0
[email protected]
Contact person for public queries
Name 45687 0
Siobhan Schabrun
Address 45687 0
University of Western Sydney, Campbelltown Campus, Locked Bag 1797, Penrith NSW 2751
Country 45687 0
Australia
Phone 45687 0
+61 2 4620 3497
Fax 45687 0
+61 2 4620 3792
Email 45687 0
[email protected]
Contact person for scientific queries
Name 45688 0
Siobhan Schabrun
Address 45688 0
University of Western Sydney, Campbelltown Campus, Locked Bag 1797, Penrith NSW 2751
Country 45688 0
Australia
Phone 45688 0
+61 2 4620 3497
Fax 45688 0
+61 2 4620 3792
Email 45688 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Background: Chronic primary headache disorders are... [More Details]

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