ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000667112

Ethics application status

Approved

Date submitted

18/04/2019

Date registered

3/05/2019

Date last updated

3/05/2019

Date data sharing statement initially provided

3/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Using transcranial direct current stimulation to boost the hypoalgesic effects of exercise:: A randomised controlled experimental study

Scientific title

Using transcranial direct current stimulation to boost the hypoalgesic effects of exercise in healthy participants:: A randomised controlled experimental study

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Mechanical hyperalgesia

Pain

Muscle soreness

Condition category

Condition code

Neurological

Studies of the normal brain and nervous system

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will attend two sessions in the brain stimulation labs at Western Sydney University (‘Day 0’ and ‘Day 2’), which will take 30 and 90 minutes, respectively. On Day 0, individuals will complete formal screening to determine their eligibility for the study. If included, demographic data will be collected (pre-injection measures: age, height, weight, current levels of physical activity and beliefs about pain) and A 5 µg (0.2 mL) bolus of recombinant human NGF will be administered into the right extensor carpi radialis brevis (ECRB) muscle belly. One experimental will administer all injections. Participants will return on Day 2 and will be randomly allocated using a computer-generated random number table into the intervention group (active tDCS and exercise) or the control group (sham tDCS and exercise). Allocation will be concealed using opaque envelopes (prepared by an independent researcher) and will be opened by the researcher responsible for tDCS settings. The other researcher, responsible for collecting outcome measures, will remain blinded to the group allocation. Participants will receive active or sham tDCS and will complete a subsequent isometric grip exercise. At each timepoint (pre-injection, pre-tDCS, immediately post-exercise and 15-minute post exercise) pressure pain thresholds (PPTs), pain ratings, muscle soreness ratings and conditioned pain modulation (CPM) measures will be taken.

ACTIVE tDCS (INTERVENTION): Participants in the active tDCS group will receive 20 minutes of direct current stimulation (using a DC-Stimulator, Rogue Resolutions Inc., IImenau, Germany) via two 35cm2 surface sponge electrodes soaked with 0.9% saline. The active tDCS electrode (anode) will be positioned on the scalp over the motor cortical representation for the ECRB muscle (the 'hotspot', determined using transcranial magnetic stimulation). Prior to application, the scalp will be lightly abraded using Nuprep skin prep gel (Weaver and Company, Colorado, USA) then cleaned with alcohol to reduce current impedance. The stimulation parameters used for active tDCS will be the same as those used in previous studies that have shown to produce hypoalgesic effects in chronic musculoskeletal pain (Chang et al., 2017). The Active tDCS is delivered at 1 milliAmps and the current will take 10 seconds to build in intensity (fade in) and 10 seconds to decrease in intensity (fade out). Following active tDCS, the grip force task will commence. Participants will remain seated with their right elbow resting on a table in 90 degrees of flexion and forearm in neutral (between pronation and supination). Participants will be asked to squeeze a grip dynamometer as hard as possible (termed ‘maximal voluntary contraction [MVC]’) for 5 seconds and this will be performed 3 times with 1-minute rest between trials. The exercise protocol itself will involve squeezing the grip dynamometer at 25% of the participant's MVC for 3 minutes. Visual feedback will be provided to ensure that the participant maintains this contraction.

Researcher notes will be audited and reviewed by the supervisors of the student conducting the data collection. All participants will be blinded to group allocation. At the conclusion of each session, participants will be asked the group to which they believe they have been allocated. This will be done to assess the fidelity of participant blinding.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

CONTROL: Participants in the sham tDCS group will have the electrodes placed in an identical position to the active tDCS group, following the procedure described above. However, stimulation will be turned on for 15 seconds then turned off. This provides participants with the initial itching sensation associated with tDCS but does not induce changes in cortical excitability (Chang et al., 2017). All participants (active and sham tDCS) will be informed that they may or may not experience tingling or itching sensations during stimulation. This procedure has been shown to effectively blind participants to the stimulation condition (Gandiga, Hummel, & Cohen, 2006).

Following sham tDCS, the grip force task will commence. Participants will remain seated with their right elbow resting on a table in 90 degrees of flexion and forearm in neutral (between pronation and supination). Participants will be asked to squeeze a grip dynamometer as hard as possible (termed ‘maximal voluntary contraction [MVC]’) for 5 seconds and this will be performed 3 times with 1-minute rest between trials. The exercise protocol itself will involve squeezing the grip dynamometer at 25% of the participant's MVC for 3 minutes. Visual feedback will be provided to ensure that the participant maintains this contraction.

Control group

Placebo

Outcomes

Primary outcome [1]

Mechanical hyperalgesia (measured using pressure pain thresholds). Pressure is applied perpendicular to the surface of the skin using a handheld algometer (Somedic, 1 cm2 probe) at a rate of 30 kPa/s. The PPT is defined as the point at which the participant reported that a sensation of pressure first changed to a sensation of pain. Three readings are recorded at 1-minute intervals. The average of the three measures is used during statistical analyses.

Timepoint [1]

Pre-injection (Day 0), pre-tDCS (Day 2). immediately post-exercise (Day 2, primary time point), 15 minutes post-exercise (Day 2).

Primary outcome [2]

Muscle Soreness (in the ECRB muscle) on a 7-point Likert Scale.

Timepoint [2]

Pre-injection (Day 0), pre-tDCS (Day 2). immediately post-exercise (Day 2, primary timepoint), 15 minutes post-exercise (Day 2).

Primary outcome [3]

Conditioned pain modulation (CPM). In this study, the average of three PPT recordings over the right ECRB represented the test stimulus. Immersion of the left hand in temperature-controlled ice water (4-6oC) was used as the conditioning stimulus. Pressure pain thresholds were recorded prior to cold immersion and following 1 minute of immersion, with the difference in PPT recordings being used to quantify the CPM effect.

Timepoint [3]

Pre-injection (Day 0), pre-tDCS (Day 2). immediately post-exercise (Day 2, primary timepoint), 15 minutes post-exercise (Day 2).

Secondary outcome [1]

Pain intensity on a 10-point scale (0 = no pain, 10 = worst pain imaginable)

Timepoint [1]

Pre-injection (Day 0), pre-tDCS (Day 2). immediately post-exercise (Day 2), 15 minutes post-exercise (Day 2).

Eligibility

Key inclusion criteria

-Healthy
-No previous exposure to transcranial direct current stimulation (tDCS)
- Able to understand and speak English

Minimum age

18 Years

Maximum age

35 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

-Failure to pass the Transcranial Magentic Stimulation Safety Screen questionnaire
-Cardiovascular disorders
-Use of neuroactive drugs
-Pregnancy
-History of neurological illness
-History of musculoskeletal illness
-Previous exposure to TMS
-Contraindications to tDCS or TMS
-Current acute pain or recent musculoskeletal injury
-History of chronic pain

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)

Simple randomisation using a computerised random number generator

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving 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

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

16/05/2019

Actual

Date of last participant enrolment

Anticipated

16/05/2019

Actual

Date of last data collection

Anticipated

31/05/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

Western Sydney University

Address [1]

Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560

Country [1]

Australia

Primary sponsor type

University

Name

Western Sydney University

Address

Western Sydney University, Campbelltown Campus, Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney University Human Research Ethics Comittee

Ethics committee address [1]

Human Ethics Officer
Research Engagement, Development and Innovation (REDI)
Western Sydney University
Locked Bag 1797
Penrith NSW 2751

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/04/2019

Ethics approval number [1]

Summary

Brief summary

Exercise is considered a first-line treatment for chronic musculoskeletal pain (Pescatello, 2014). One mechanism contributing to the near-ubiquitous prescription of exercise in chronic pain populations is ‘exercise-induced hypoalgesia’. Exercise-induced hypoalgesia (EIH) is the term used to describe acute reductions in pain sensitivity following exercise (Koltyn, Brellenthin, Cook, Sehgal, & Hillard, 2014).  However, in chronic musculoskeletal pain, EIH effects are, at best, small to moderate. Exploration of novel interventions that could bolster EIH effects are therefore warranted. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that provides a promising avenue to boost the EIH response (O'Connell, Marston, Spencer, DeSouza, & Wand, 2018). ’However, the effectiveness of tDCS in enhancing EIH is not known. Therefore, this study will investigate whether tDCS can be used to boost the hypoalgesic effect of isometric exercise  .

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Rocco Cavaleri

Address

Western Sydney University, Campbelltown Campus, Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560

Country

Australia

Phone

+61 2 4620 3994

Fax

R.cavaleri@westernsydney.edu.au

Contact person for public queries

Name

Rocco Cavaleri

Address

Western Sydney University, Campbelltown Campus, Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560

Country

Australia

Phone

+61 2 4620 3994

Fax

R.cavaleri@westernsydney.edu.au

Contact person for scientific queries

Name

Rocco Cavaleri

Address

Western Sydney University, Campbelltown Campus, Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560

Country

Australia

Phone

+61 2 4620 3994

Fax

R.cavaleri@westernsydney.edu.au

Data sharing statement

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

Yes

What data in particular will be shared?

All of the individual participant data collected during the trial, after de-identification

When will data be available (start and end dates)?

Immediately following publication until 5 years after publication.

Available to whom?

Case-by-case basis at the discretion of the Principal Investigator

Available for what types of analyses?

Any purpose deemed appropriate by the Principal Investigator

How or where can data be obtained?

Access subject to approvals by Principal Investigator, requirement to sign data access agreement

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Transcranial Direct Current Stimulation Accelerates The Onset of Exercise-Induced Hypoalgesia: A Randomized Controlled Study.	2021	https://dx.doi.org/10.1016/j.jpain.2020.08.004

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically