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Trial registered on ANZCTR


Trial ID
ACTRN12613001232729
Ethics application status
Approved
Date submitted
7/11/2013
Date registered
11/11/2013
Date last updated
11/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Modulation of chronic pain perception with noninvasive
central and peripheral nervous system stimulation.
Scientific title
The effect of transcranial direct current stimulation and transcutaneous electrical nerve stimulation on improving pain intensity, physical functioning, mental health and quality of life in a chronic pain population awaiting pain clinic intervention.
Secondary ID [1] 283452 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic musculoskeletal pain 290374 0
Condition category
Condition code
Musculoskeletal 290764 290764 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group 1: Subjects receive transcranial direct current stimulation and transcutaneous electrical nerve stimulation only:

Transcranial direct current stimulation (Chattanooga Ionto, Tennessee, USA).
Dose: 2mA
Duration: 30min
Mode of administration: 5 consecutive daily sessions (1 session/ treatment day) applied over the dominant motor cortex.

Transcutaneous electrical nerve stimulation (Comffit T-20).
Specification: 10Hz, non-noxious intensity
Duration: 30min
Mode of administration: 5 consecutive daily sessions (1 session/ treatment day) applied over the bodily site of pain.

Transcranial direct current stimulation and transcutaneous electrical nerve stimulation are applied simultaneously during each of the 5 consecutive daily sessions.
Intervention code [1] 288169 0
Treatment: Devices
Comparator / control treatment
Comparator group 1: Subjects receive transcranial direct current stimulation and sham transcutaneous electrical nerve stimulation only:

Transcranial direct current stimulation (Chattanooga Ionto, Tennessee, USA).
Dose: 2mA
Duration: 30min
Mode of administration: 5 consecutive daily sessions (1 session/ treatment day) applied over the dominant motor cortex.

Sham transcutaneous electrical nerve stimulation (Comffit T-20).
Specification: 10Hz, non-noxious intensity until subject reports initial sensation. The device is then turned off. The stimulating electrodes, however, remain on the stimulation site for a total of 30 minutes.
Duration: 30min
Mode of administration: 5 consecutive daily sessions (1 session/ treatment day) applied over site of pain.

Transcranial direct current stimulation and sham transcutaneous electrical nerve stimulation are applied simultaneously during each of the 5 consecutive daily sessions.



Comparator group 2: Subjects receive transcutaneous electrical nerve stimulation and sham transcranial direct current stimulation only:

Sham transcranial direct current stimulation
Dose: 2mA
Duration: The device is turned off slowly, out of the subject’s field of view, after 30 seconds of 2mA tDCS. The stimulating electrodes, however, remain on the stimulation site for a total of 30 minutes.
Mode of administration: 5 consecutive daily sessions (1 session/treatment day) applied over the dominant motor cortex.

Transcutaneous electrical nerve stimulation (Comffit T-20).
Dose: 10Hz, non-noxious intensity
Duration: 30 minutes
Mode of administration: 5 consecutive daily sessions (1 session/treatment day) applied over site of pain.


Transcutaneous electrical nerve stimulation and sham transcranial direct current stimulation and are applied simultaneously during each of the 5 consecutive daily sessions.



Control group 1: Subjects receive sham transcranial direct current stimulation and sham transcutaneous electrical nerve stimulation only:


Sham transcranial direct current stimulation
Dose: 2mA
Duration: The device is turned off slowly, out of the subject’s field of
view, after 30 seconds of 2mA tDCS. The stimulating electrodes,
however, remain on the stimulation site for a total of 30 minutes.
Mode of administration: 5 consecutive daily sessions (1 session/treatment day) applied over the dominant motor cortex.

Sham transcutaneous electrical nerve stimulation (Comffit T-20).
Specification: 10Hz, non-noxious intensity until subject reports initial sensation. The device is then turned off. The stimulating electrodes, however, remain on the stimulation site for a total of 30 minutes.
Duration: 30min
Mode of administration: 5 consecutive daily sessions (1 session/ treatment day) applied over site of pain.

Sham transcranial direct current stimulation and sham transcutaneous electrical nerve stimulation are applied simultaneously during each of the 5 consecutive daily sessions.
Control group
Placebo

Outcomes
Primary outcome [1] 290760 0
Pain visual analogue scale
Timepoint [1] 290760 0
The primary outcome will be measured before and after intervention session 1, after intervention session 5 and 4 weeks after intervention session 5.
Secondary outcome [1] 305203 0
Human salivary biomarker (e.g. BDNF) will be collected and measured using immuno-histo-chemical techniques.
Timepoint [1] 305203 0
The secondary outcome will be collected before intervention session 1 and after intervention session 5
Secondary outcome [2] 305204 0
Perception of participant treatment awareness using visual analogue scales.
Timepoint [2] 305204 0
The secondary outcome will be measured after intervention session 5 only.
Secondary outcome [3] 305205 0
Sensitivity to electrical body pain stimuli: Electrical stimuli will be delivered to the subject's hand using a constant current stimulator. The subject will be asked to state when they can first ‘detect’ the electrical stimulus. The current intensity (mA) will be recorded. The electrical stimuli will be delivered until the subject can first confidently perceive the stimulus as being ‘painful.’ The current intensity (mA) will again be recorded. The trial will be repeated for a total of three times. The mean of 3 electrical ‘detection’ and ‘pain detection’ thresholds will be calculated.
Timepoint [3] 305205 0
The secondary outcome will be measured before intervention session 1 and after intervention session 5.
Secondary outcome [4] 305206 0
Sensitivity to pressure body pain stimuli: Pressure stimuli will be delivered to the subject's hand using a pressure algometer. The pressure stimuli will be delivered until the subject can first confidently perceive the stimulus as being ‘painful.’ The pressure (kPa) will be recorded. The trial will be repeated for a total of three times. The mean of 3 ‘pain detection’ thresholds will be calculated.
Timepoint [4] 305206 0
The secondary outcome will be measured before intervention session 1 and after intervention session 5.
Secondary outcome [5] 305207 0
Sensitivity to thermal body pain stimuli: For the cold pressor test, the
subject’s hand will be immersed in ice saturated water (0-1 degrees
celcius) to the wrist level, for a maximum of 2 min. The subject will first be
asked to state when they can first confidently perceive the stimulus as
being ‘painful.’ This time duration will be recorded. The subject will be
instructed to withdraw the hand when they feel the pain as intolerable.
This time duration will also be recorded. A single ‘pain detection’ threshold
and ‘pain tolerance’ threshold will be calculated.
Timepoint [5] 305207 0
The secondary outcome will be measured before intervention session 1 and after intervention session 5.
Secondary outcome [6] 305332 0
Patients Global Impression of Change (PGIC) question
Timepoint [6] 305332 0
The primary outcome will be measured after intervention session 5, 4 weeks after intervention session 5 and before and after your future treatment at the Interdisciplinary Persistent Pain Service.
Secondary outcome [7] 305333 0
Modified Brief Pain Inventory (BPI)
Timepoint [7] 305333 0
The primary outcome will be measured before and after intervention session 1, after intervention session 5, 4 weeks after intervention session 5 and before and after your future treatment at the Interdisciplinary Persistent Pain Service.
Secondary outcome [8] 305334 0
Kessler Distress Psychological Scale (K-10)
Timepoint [8] 305334 0
The primary outcome will be measured before and after intervention session 1, after intervention session 5, 4 weeks after intervention session 5 and before and after your future treatment at the Interdisciplinary Persistent Pain Service.
Secondary outcome [9] 305335 0
Pain Self Efficacy Questionnaire (PSEQ)
Timepoint [9] 305335 0
The primary outcome will be measured before and after intervention session 1, after intervention session 5, 4 weeks after intervention session 5 and before and after your future treatment at the Interdisciplinary Persistent Pain Service.
Secondary outcome [10] 305339 0
World Health Organisation Quality of life (WHO-QOL) questionnaire
Timepoint [10] 305339 0
The primary outcome will be measured before and after intervention session 1, after intervention session 5 and 4 weeks after intervention session 5.

Eligibility
Key inclusion criteria
1) aged 18-64,
2) chronic musculo-skeletal pain (>3 months, prediagnosed) 3) awaiting pain clinic intervention at the Gold Coast Interdisciplinary Persistent Pain Centre


Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria to be used by the Interdisciplinary Persistent Pain Centre: People with medical acuity score of >20 classed as a category one referal.

Exclusion criteria to be used by the coordinating principal researcher: Spinal surgery in the past 6 months,
persistent neurological condition, current abuse of elicit substances and alcohol, pregnancy, does not understand English, magnetic/ metallic pieces inside skull, implanted metal devices (Pacemaker, cochlear device, medication pump, nervous system stimulators), cardiac disease, skin lesion near electrode sites, acute musculoskeletal injuries.

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Based on a power analysis (calculated by G*Power software) providing 80% power with one sided alpha =.05 and an effect size (f) of =.5 based on analysis of co-variance (adjusting for baseline scores), and allowing for 30% dropout rate, we aim to recruit a total of 80 volunteers (i.e. 20 volunteers / group) for the study.

Tests conducted will be examined using a statistical software package
(SPSS v. 20).


We aim to examine differences in the outcome measures before
and after the application of brain stimulation protocols and between
treatment groups using paired t-tests and ANCOVA.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1616 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 7498 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 288169 0
University
Name [1] 288169 0
Bond University Higher Degree Student support scheme
Address [1] 288169 0
2 Promethean Way,
Robina
4226 Gold Coast
Queensland
Country [1] 288169 0
Australia
Primary sponsor type
University
Name
Bond University
Address
2 Promethean Way,
Robina
4226 Gold Coast
Queensland
Country
Australia
Secondary sponsor category [1] 286890 0
None
Name [1] 286890 0
Address [1] 286890 0
Country [1] 286890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290081 0
Gold Coast Health Service Human Research Ethics Committee
Ethics committee address [1] 290081 0
Gold Coast Health
Level 5
D Block, Room 101
Gold Coast University Hospital
Hospital Boulevard
SOUTHPORT QLD 4215
Ethics committee country [1] 290081 0
Australia
Date submitted for ethics approval [1] 290081 0
Approval date [1] 290081 0
10/10/2013
Ethics approval number [1] 290081 0
HREC/13/QGC/79

Summary
Brief summary
The aims of the randomized controlled research project are to investigate the effects of five consecutive daily sessions (1 x 30 minute session/ treatment day) of both:
1) transcranial direct current stimulation (tDCS) and
2) transcutaneous electrical nerve stimulation (TENS)
in improving pain intensity, physical functioning, mental health and quality of life in a chronic pain population awaiting pain clinic intervention. The study also aims to investigate whether prior treatment with consecutive daily sessions of both tDCS and TENS improves the outcomes of pain clinic intervention.

Outcome measures and methods that will be used to achieve these aims will include:
1) asking subjects to complete self-reported questionnaires that include questions related to measures of pain, physical function, mental health and quality of life
2) measuring the subject's sensitivity to mechanical, electrical and thermal induced pain stimuli (i.e. the stimulus intensity will be increased until the subject can confidently perceive that the pain elicited by the stimulus ‘matches’ the level of intensity of their current pain problem) delivered to the subject's dominant hand using a pressure algometer, electric current stimulator and thermal stimulus respectively
3) collecting subject's saliva to assess induced changes to pain related biomarkers using immunohistochemical techniques.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43854 0
A/Prof Allan Abbott
Address 43854 0
Bond University
2 Promethean Way,
Robina
4226 Gold Coast
Queensland
Country 43854 0
Australia
Phone 43854 0
+ 61 7 55954449
Fax 43854 0
Email 43854 0
aabbott@bond.edu.au
Contact person for public queries
Name 43855 0
Mr Brookes Folmli
Address 43855 0
Bond University
2 Promethean Way,
Robina
4226 Gold Coast
Queensland
Country 43855 0
Australia
Phone 43855 0
+ 61 432102778
Fax 43855 0
Email 43855 0
brfolmli@bond.edu.au
Contact person for scientific queries
Name 43856 0
A/Prof Allan Abbott
Address 43856 0
Bond University
2 Promethean Way,
Robina
4226 Gold Coast
Queensland
Country 43856 0
Australia
Phone 43856 0
+ 61 7 55954449
Fax 43856 0
Email 43856 0
aabbott@bond.edu.au