Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001072808
Ethics application status
Approved
Date submitted
1/10/2012
Date registered
8/10/2012
Date last updated
27/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain processing in patients after severe burns versus a population of unaffected volunteers: a comparison
Scientific title
Pain processing in patients after severe burns versus a population of unaffected volunteers: a comparison
Secondary ID [1] 280899 0
Nil Known
Universal Trial Number (UTN)
U1111-1132-8913
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain processing in burns patients 286976 0
Pain processing in healthy volunteers 286977 0
Condition category
Condition code
Injuries and Accidents 287312 287312 0 0
Burns

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparison of the information obtained from the non-traumatic nerve stimulation testing in burns patients to that of a group of matched controls who have also undergone identical nerve stimulation testing. The duration of testing is a single 60 minute session
Intervention code [1] 285329 0
Not applicable
Comparator / control treatment
Healthy matched control group
Control group
Active

Outcomes
Primary outcome [1] 287588 0
Amount of electrical stimulation (in miivolt) required to first produce a sensation of pain as produced by a single twitch according to known physiological testing algorithms for evaluation of threshold
Timepoint [1] 287588 0
6 months post burn injury
Primary outcome [2] 287589 0
Amount of electrical stimulation (in miivolt) required to first produce a sensation of pain as produced by a single twitch according to known physiological testing algorithms for evaluation of threshold
Timepoint [2] 287589 0
once off visit after burns group complete on healthy volunteers
Secondary outcome [1] 298461 0
Measurement of wind up by specific patterns of stimulation using elctrophysiological testing (evaluating a pain threshold and applying 5 consecutive stimulations at 110% of the electrical threshold ) over a normal area of skin at a similar dermatomal level as a previous burns injury
Timepoint [1] 298461 0
At 6 month post burn injury
Secondary outcome [2] 298462 0
Measurement of wind up by specific patterns of stimulation using elctrophysiological testing (evaluating a pain threshold and applying 5 consecutive stimulations at 110% of the electrical threshold ) over a normal area of skin at a similar dermatomal level as a previous burns injury
Timepoint [2] 298462 0
once off visit after burns group complete on healthy volunteers
Secondary outcome [3] 298463 0
demographic data is collected using a survey
Timepoint [3] 298463 0
At 6 month post burn injury visit, once off visit for healthy volunteers.

Eligibility
Key inclusion criteria
Burns Group
1. Burns injury sustained approximately 6 months prior which was 10% or greater in total body surface area not affecting the area of testing (ankle and leg) bilaterally
2. Alert and orientated
3. Ability to give informed consent
4. Able to cooperate with the nerve stimulation test
5. No current pain at rest
Healthy Volunteer Group
1. Alert and orientated
2. Ability to give informed consent
3. Able to cooperate with the nerve stimulation test
4. Age average age of burns group +/- 5 years.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Burns Group
1. Patient Refusal
2. 2. Burns/scarring to either of the two lower limbs below the knee
3. Inability to provide informed consent
4. Psychotic or paranoid disease
5. Chronic pain syndrome prior to burn
6. Acute/chronic brain syndrome
7. Current opioid therapy
8. History of untreated hypertension
9. History of diabetes
10. History of peripheral neuropathy


Health Volunteer group
1. Patient Refusal
2. Inabilility to provide informed consent
3. Current or past history of psychotic or paranoid disease
4. Past history of chronic pain sydrome(s)
5. Acute/chronic brain sydrome
6. Recent (within 2 weeks) or current opioid use
7. History of untreated hypertension
8. History of diabetes
9. History of peripheral neuropathy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285803 0
Hospital
Name [1] 285803 0
Alfred Hospital Small Projects Grant
Country [1] 285803 0
Australia
Primary sponsor type
Individual
Name
Dr Alex Konstantatos
Address
The Alfred Hospital
c/o Department of Anaesthesia dn Pain Medicine
Commercial Rd
Prahran
Victoria 3181
Country
Australia
Secondary sponsor category [1] 284628 0
Individual
Name [1] 284628 0
Dr Harriet Beevor
Address [1] 284628 0
The Alfred Hospital
c/o Department of Anaesthesia dn Pain Medicine
Commercial Rd
Prahran
Victoria 3181
Country [1] 284628 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287816 0
Alfred Health Ethics Committee
Ethics committee address [1] 287816 0
Po Box 315
Prahran Vic 3181
Ethics committee country [1] 287816 0
Australia
Date submitted for ethics approval [1] 287816 0
Approval date [1] 287816 0
18/06/2010
Ethics approval number [1] 287816 0
52/10

Summary
Brief summary
Patients with previous burns injuries are subject to abnormal pain processing responses compared to people who have never been affected by severe burns. We propose to run a pilot study which will demonstrate whether patients have ongoing abnormal pain responses. This would be determined by using a form of quantitative sensory testing which evaluates the integrity of pain pathways.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34478 0
Dr Alex Konstantatos
Address 34478 0
The Alfred Hospital
C/O Department of Anaesthesia and Pain medicine
PO Box 315
Prahran, Victoria 3181
Country 34478 0
Australia
Phone 34478 0
+61390763176
Fax 34478 0
Email 34478 0
[email protected]
Contact person for public queries
Name 17725 0
Dr Dr Alex Konstantatos
Address 17725 0
The Alfred Hospital
C/o Department of Anaesthetsia and Pain Medicine
Po Box 315
Prahran Vic 3181
Country 17725 0
Australia
Phone 17725 0
+61390763176
Fax 17725 0
+61390762813
Email 17725 0
[email protected]
Contact person for scientific queries
Name 8653 0
Dr Dr Alex Konstantatos
Address 8653 0
The Alfred Hospital
C/o Department of Anaesthetsia and Pain Medicine
Po Box 315
Prahran Vic 3181
Country 8653 0
Australia
Phone 8653 0
+61390763176
Fax 8653 0
+61390762813
Email 8653 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

Documents added manually
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Documents added automatically
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