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Trial registered on ANZCTR


Registration number
ACTRN12613000004763
Ethics application status
Approved
Date submitted
10/12/2012
Date registered
3/01/2013
Date last updated
27/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Thermal Stimuli on the Response to Intradermal Capsaicin in Healthy Male Participants
Scientific title
The effect of thermal stimuli on the outcomes spontaneous pain, flare, allodynia and hyperalgesia in response to intradermal capsaicin in healthy male participants
Secondary ID [1] 281640 0
NIL KNOWN
Universal Trial Number (UTN)
U1111-1137-7884
Trial acronym
TGI-003
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 287929 0
Condition category
Condition code
Anaesthesiology 288308 288308 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Intradermal capsaicin (100 micrograms) will be administered intradermally into the dominant forearm once on both study day 1 and study day 2. Intradermal capsaicin is not being used as an intervention (e.g. treatment), but instead as a method to produce neuropathic like pain symptoms in healthy pain-free volunteers. Sensitivity to two different types of thermal test will be performed in the presence of intradermal capsaicin. One thermal test involves placing a small match boxed sized thermode on participants dominant forearm for 30 seconds. Once the thermode is removed from participants dominant forearm, participants will then be asked to rate how painful the thermode was, an area of flare will be measured and participants sensitivity to von Frey hairs and a foam paintbrush will be measured. The other thermal test involves participants placing their dominant forearm onto specialised temperature bars for 30 seconds. Once participants are asked to remove their dominant forearm from the specialised temperature bars, participants will then be asked to rate how painful the speciliased temperature bars were, an area of flare will be measured and participants sensitivity to von Frey hairs and a foam paintbrush will be measured. Both thermal tests are performed at non-harmful temperatures. As the study is being conducted as a 2-way cross over design, participants will randomly be assigned to either the thermode test or the specialised temperature bars test for study visit 1 or study visit 2. Therefore, if a participant is assigned to the thermode test for study visit 1, they will be assigned to the speciliased temperature bars test for study visit 2. Thermal tests will be performed prior to intradermal capsaicin and at 5, 15, 30, 45, 60 and 90 minutes post intradermal capsaicin. Each study day will be approximately 2 hours and 45 minutes long.
Intervention code [1] 286179 0
Not applicable
Comparator / control treatment
The thermode test is considered the control in this study.
Control group
Active

Outcomes
Primary outcome [1] 288481 0
To compare the effect of the specialised temperature bars with standard warmth/heat on spontaneous pain, flare, allodynia and hyperalgesia responses induced by intradermal capsaicin.

Spontaneous pain will be assessed using a visual analogue scale. Flare will be assessed by tracing the area of visible flare onto clear acetate. The area around the injection where participants skin has become sensitive to light stroking (allodynia) will be assessed with a foam paintbrush. The area of skin around the injection that has become painful to probing which was not painful before (hyperalgesia) will be assessed using speciliased plastic rods (von Frey hairs) which bend at a known pressure. Participants will also be asked to rate any pain experienced during the foam paintbrush (allodynia) and von Frey (hyperalgesia) test.
Timepoint [1] 288481 0
Baseline (pre-capsaicin), T = 5, 15, 30, 45, 60, 90 mins post intradermal capsaicin injection
Secondary outcome [1] 300276 0
None
Timepoint [1] 300276 0
None

Eligibility
Key inclusion criteria
A participant will be eligible for inclusion in this study only if all of the following criteria apply:
1.Male
2.Right handed
3.Aged between 18-65 years inclusive
4.In good general health without clinically significant renal, hepatic, cardiac or other disease, as determined by the Principal Investigator
5.Agree to and be capable of signing the Informed Consent Form
Minimum age
18 Years
Maximum age
65 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
A participant will be excluded from the study if any of the following criteria apply:
1.Significant scarring on the planned site of investigation
2.Tattoos on the planned site of investigation
3.Suffering from an active inflammatory process (e.g. acute pain, influenza, active infection, rheumatoid arthritis etc.)
4.Have had a clinically significant infection in the 4 weeks prior to study day 1
5.Suffering form an impaired immune response, e.g. HIV/AIDS sufferers, Hep B or C sufferers, organ transplant recipients or known current history of malignancy. Significance is to be determined by the investigator
6.Taking immunosuppressant drugs e.g. azathioprine, methotrexate, cyclosporine
7.Dark skin colouration that precludes flare assessment
8.Positive urine drug screen for presence of non-prescribed drugs of abuse
9.Positive breath alcohol concentration prior to study day 1 and 2
10.Recent use of opioids (e.g. morphine use within 1 week, or codeine use (<30 mg) within last 5 days)
11.Use of anxiolytics, anti-depressants and anti-epileptic medications within the previous 4 weeks
12.Clinically significant abnormalities in blood tests conducted during screening, as determined by the Principal Investigator
13.Sensory deficits at the planned quantitative sensory testing (QST) site resulting from medical conditions, such as diabetes; alcohol neuropathy; severe thyroid, liver or kidney diseases
14.Suffering from a clinically diagnosed major psychiatric disorder, such as major depression; bipolar disorder; schizophrenia; anxiety disorder and psychosis
15.History of excessive use of alcohol, defined as more than 28 units of alcohol per week
16.Known disorder of thermal pain sensitivity (e.g. Raynaud’s Phenomenon)
17.Inability to tolerate study procedures at screening familiarisation session
18.Current or history of a chronic pain condition
19.Frequent migraines, as determined by the Principal Investigator

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
SA

Funding & Sponsors
Funding source category [1] 286445 0
University
Name [1] 286445 0
The Pain and Anaesthesia Research Clinic, The University of Adelaide
Address [1] 286445 0
The Pain and Anaesthesia Research Clinic, The University of Adelaide, Ward S4A, Royal Adelaide Hospital, Adelaide, South Australia, Australia, 5000
Country [1] 286445 0
Australia
Primary sponsor type
Individual
Name
Professor Paul Rolan
Address
Discipline of Pharmacology, School of Medical Sciences, Level 5, Medical School North, From Road, Adelaide, South Australia, 5005
Country
Australia
Secondary sponsor category [1] 285232 0
None
Name [1] 285232 0
Address [1] 285232 0
Country [1] 285232 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288525 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 288525 0
Research Ethics Committee Level 3, Hanson Institute, From Road, Adelaide, South Australia, 5000
Ethics committee country [1] 288525 0
Australia
Date submitted for ethics approval [1] 288525 0
29/11/2012
Approval date [1] 288525 0
17/01/2013
Ethics approval number [1] 288525 0
HREC/12/RAH/180

Summary
Brief summary
We wish to investigate the effect of two different types of thermal stimuli on the responses (spontaneous pain, flare, allodynia and hyperalgesia) to intradermal capsaicin in healthy male volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36490 0
Prof Paul Rolan
Address 36490 0
Discipline of Pharmacology, School of Medical Sciences, Level 5, Medical School North, From Road, Adelaide, South Australia, 5005
Country 36490 0
Australia
Phone 36490 0
+61 8 83034102
Fax 36490 0
Email 36490 0
paul.rolan@adelaide.edu.au
Contact person for public queries
Name 36491 0
Mrs Nicole Sumracki
Address 36491 0
Discipline of Pharmacology, School of Medical Sciences Level 5, Medical School North Frome Road, Adelaide, South Australia, 5005
Country 36491 0
Australia
Phone 36491 0
+61 8 83035188
Fax 36491 0
Email 36491 0
nicole.sumracki@adelaide.edu.au
Contact person for scientific queries
Name 36492 0
Mrs Nicole Sumracki
Address 36492 0
Discipline of Pharmacology, School of Medical Sciences Level 5, Medical School North Frome Road, Adelaide, South Australia, 5005
Country 36492 0
Australia
Phone 36492 0
+61 8 83035188
Fax 36492 0
Email 36492 0
nicole.sumracki@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary