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Trial registered on ANZCTR
Registration number
ACTRN12618001366246
Ethics application status
Approved
Date submitted
27/07/2018
Date registered
14/08/2018
Date last updated
14/08/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Repetitive transcranial magnetic stimulation in preventing the transition from acute to sustained pain: A randomised controlled trial
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Scientific title
Repetitive transcranial magnetic stimulation in preventing the transition from acute to sustained pain: A randomised controlled trial
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Secondary ID [1]
295676
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mechanical hyperalgesia
309033
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Pain
309214
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Functional disability
309215
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Muscle soreness
309232
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Condition category
Condition code
Neurological
307927
307927
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0
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Studies of the normal brain and nervous system
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Musculoskeletal
308088
308088
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study involved 8 experimental sessions across a 14-day period (Day -2, 0, 2, 4, 6, 8, 11, and 14). Progressive muscle soreness and mechanical hyperalgesia are induced via repeated NGF injections. A 5 µg (0.2 mL) bolus of recombinant human NGF is injected into the muscle belly of the right ECRB using a 1 ml syringe and disposable 27G needle. Injections are administered at the end of the test sessions on Days 0, 2, and 4. The injection site is located 1cm lateral and 5cm distal to the origin of a line extending from the lateral epicondyle to the midline of the wrist crease. One experimenter administers all injections.
The intervention is high frequency repetitive transcranial magnetic stimulation (rTMS) applied to the motor cortex (the ‘hotspot’) region dedicated to the right ECRB using a Magstim Super Rapid2 (Magstim Co. Ltd, Dyfed, UK) and a 70mm air cooled figure-of-eight coil. A total of 1200 stimuli are delivered at a frequency of 10 Hz, in 20 trains of 6 seconds (54-second inter-train interval). Stimuli are delivered at 90% of the participant's resting motor threshold. Active or sham rTMS are delivered following repeated intramuscular injections. Each rTMS session takes approximately 20 minutes. The rTMS protocol consists of one session per day for 5 consecutive days (Days 4, 5, 6, 7, and 8), with rTMS being delivered after all assessments are performed. Stimuli are delivered by the chief investigator, who is familiar with the use of TMS. A second researcher is present to monitor the participant and the fidelity of the intervention. The chief investigator's supervisors provide support outside of the lab.
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Intervention code [1]
301991
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Treatment: Devices
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Comparator / control treatment
For sham rTMS, the coil is held at 90 degrees relative to the skull , rather than tangentially, to direct the magnetic field away from cortical tissue and mimic the active condition.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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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 (refs). Three readings are recorded at 1-minute intervals. The average of the three measures is used during statistical analyses.
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Assessment method [1]
306900
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Timepoint [1]
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Days 6, 8 (primary time point), 11, and 14 (post-rTMS commencement). Assessments are also taken on Days 0, 2 and 4 (pre-rTMS commencement).
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Primary outcome [2]
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Pain and disability measured using the Patient Rated Tennis Elbow Evaluation (PRTEE)
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Assessment method [2]
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Timepoint [2]
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Days 6, 8 (primary time point), 11, and 14 (post-rTMS commencement). Assessments are also taken on Days 0, 2 and 4 (pre-rTMS commencement).
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Primary outcome [3]
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Transcranial Magnetic Stimulation (TMS) motor cortical maps.
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Assessment method [3]
306902
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Timepoint [3]
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Days 6, 8 (primary time point), 11, and 14 (post-rTMS commencement). Assessments are also taken on Days 0, 2 and 4 (pre-rTMS commencement).
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Secondary outcome [1]
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Muscle Soreness (in the ECRB muscle) on a 7-point Likert Scale.
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Assessment method [1]
350052
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Timepoint [1]
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Days 6, 8, 11, and 14 (post-rTMS commencement). Assessments are also taken on Days 0, 2 and 4 (pre-rTMS commencement).
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Secondary outcome [2]
350053
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Pain area and distribution (body charts). (composite outcome)
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Assessment method [2]
350053
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Timepoint [2]
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Days 6, 8, 11, and 14 (post-rTMS commencement). Assessments are also taken on Days 0, 2 and 4 (pre-rTMS commencement).
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Secondary outcome [3]
350055
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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.
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Assessment method [3]
350055
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Timepoint [3]
350055
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Days 6, 8, 11, and 14 (post-rTMS commencement). Assessments are also taken on Days 0, 2 and 4 (pre-rTMS commencement).
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Eligibility
Key inclusion criteria
-Healthy
-No previous exposure to repetitive transcranial magnetic stimulation (rTMS)
- Able to understand and speak English
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Minimum age
20
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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 rTMS
-Contraindications to rTMS or TMS
-Current acute pain or recent musculoskeletal injury
-History of chronic pain
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised random number generator
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
5/12/2016
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Date of last participant enrolment
Anticipated
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Actual
27/09/2017
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Date of last data collection
Anticipated
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Actual
10/10/2017
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Sample size
Target
30
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Western Sydney University
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Address [1]
300260
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Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
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Country [1]
300260
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Australia
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Primary sponsor type
University
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Name
Western Sydney University
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Address
Western Sydney University, Campbelltown Campus, Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
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Country
Australia
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Secondary sponsor category [1]
299683
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None
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Name [1]
299683
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NA
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Address [1]
299683
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NA
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Country [1]
299683
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301078
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Western Sydney University Human Research Ethics Comittee
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Ethics committee address [1]
301078
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Human Ethics Officer
Research Engagement, Development and Innovation (REDI)
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
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Ethics committee country [1]
301078
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Australia
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Date submitted for ethics approval [1]
301078
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24/09/2016
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Approval date [1]
301078
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07/11/2016
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Ethics approval number [1]
301078
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H11896
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Summary
Brief summary
The purpose of this study is to i) determine whether a 5-day block of high frequency rTMS, delivered to the motor cortex, can be used to treat the pain, mechanical hyperalgesia, and disability associated with repeated intramuscular injection of human nerve growth factor (NGF) and ii) determine whether a 5-day block of high frequency rTMS, delivered to the motor cortex, reduces the motor cortical changes associated with the transition from acute to sustained pain. Three injections of NGF will be delivered and active or sham rTMS will commence 4 days post-injection.
prevent the transition from acute to sustained pain associated with repeated intramuscular injection of human nerve growth factor (NGF).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Rocco Cavaleri
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Address
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Western Sydney University, Campbelltown Campus, Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
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Country
85806
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Australia
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Phone
85806
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+61 2 4620 3994
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Fax
85806
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Email
85806
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[email protected]
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Contact person for public queries
Name
85807
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Mr Rocco Cavaleri
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Address
85807
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Western Sydney University, Campbelltown Campus, Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
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Country
85807
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Australia
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Phone
85807
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+61 2 4620 3994
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Fax
85807
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Email
85807
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[email protected]
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Contact person for scientific queries
Name
85808
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Mr Rocco Cavaleri
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Address
85808
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Western Sydney University, Campbelltown Campus, Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
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Country
85808
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Australia
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Phone
85808
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+61 2 4620 3994
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Fax
85808
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Email
85808
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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