Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000444886
Ethics application status
Approved
Date submitted
16/02/2012
Date registered
18/04/2012
Date last updated
2/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of Temperature Perception in Patents with Unilateral Sciatica
Scientific title
Do patients with unilateral sciatica respond differently to the hot and cold temperature sensation compared to pain-free volunteers?
Secondary ID [1] 279954 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unilateral sciatica 285869 0
Condition category
Condition code
Neurological 286054 286054 0 0
Other neurological disorders
Injuries and Accidents 286574 286574 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessing response to the specialised temperature bars in patients with unilateral sciatica and pain-free volunteers. Participants will be subjected to two different types of thermal stimuli, the specialised temperature bars and cold and heat pain thresholds on both the left and right side calf, palm and face. Participants fill in visual analogue scales rating any pain, heat, unpleasntness etc experienced from the specialised. Participants will be investigated over the course of 2 hours and 45 minutes
Intervention code [1] 284285 0
Not applicable
Comparator / control treatment
Patients with unilateral sciatica and pain-free volunteers will receive the two different types of thermal stimuli
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286536 0
To investigate whether the response to the specialised temperature bars differs between patients with unilateral sciatica and pain-free volunteers.
Timepoint [1] 286536 0
1x time after each specialised temperature bars test (18 thermal grill tests in one day)
Secondary outcome [1] 296106 0
1. To investigate whether heat and cold pain thresholds differ between patients with unilateral sciatica and pain-free volunteers. Heat and cold pain threshold will be determined using a TSA-II neurosensory analyser, Medoc.
Timepoint [1] 296106 0
3x per body site. 6x body sites tested. This will be tested at one time point only, prior to testing response to the specialised temperature bars.
Secondary outcome [2] 296107 0
To investigate whether the response to the specialised temperature bars differs between patients with unilateral sciatica affected body region and unaffected body regions.
Timepoint [2] 296107 0
1x time after each specialised temperature bars test (18 thermal grill tests in one day)
Secondary outcome [3] 296108 0
3. To investigate whether heat and cold pain thresholds differ between patients with unilateral sciatica affected body region and unaffected body regions. Heat and cold pain threshold will be determined using a TSA-II neurosensory analyser, Medoc.
Timepoint [3] 296108 0
3x per body site, 6x body sites tested. This will be tested at one time point only, prior to testing response to the specialised temperature bars.
Secondary outcome [4] 296109 0
To investigate whether the response to the specialised temperature bars differs between patients with unilateral sciatica on opioids and not on opioids
Timepoint [4] 296109 0
1x time each after each specialised temperature bars test (18 thermal grill tests in one day)
Secondary outcome [5] 296110 0
5. To investigate whether heat and cold pain thresholds differ between patients with unilateral sciatica on opioids and not on opioids. Heat and cold pain threshold will be determined using a TSA-II neurosensory analyser, Medoc.
Timepoint [5] 296110 0
3x per body site, 6x body sites tested. This will be tested at one time point only, prior to testing response to the specialised temperature bars.
Secondary outcome [6] 296111 0
6. To investigate the response of pro-inflammatory cytokine release after ex vivo TLR agonists and (+)-naloxone stimulation in white cell harvest obtained from patients with unilateral sciatica on opioids and those not on opioids and pain-free volunteers
Timepoint [6] 296111 0
This will be investigated once blood has been collected from the participant. Blood is collected at the beginning of the study visit.
Secondary outcome [7] 296112 0
7. To investigate the influence of genetic polymorphisms on variation in pain perception and tolerance. Associations between genetic polymorphisms (using genotyping) and pain perception will be investigated.
Timepoint [7] 296112 0
DNA will be extracted in batches up to a year after collection. Genotyping will be performed in batches up to 25 years after collection as new genetic polymorphisms arise.
Secondary outcome [8] 296113 0
To investigate whether depressive symptoms (as assessed by the Beck Depression Inventory-II) in both patients with unilateral sciatica and pain-free volunteers correlate with thermal pain thresholds or responses to the specialised temperature bars and to investigate whether depressive symptoms differ between patients with unilateral sciatica and pain-free volunteers
Timepoint [8] 296113 0
1x before any testing begins
Secondary outcome [9] 296114 0
To investigate whether early morning salivary cortisol levels in both patients with unilateral sciatica and pain-free volunteers correlate with depressive symptoms (as assessed by the Beck Depression Inventory-II), thermal pain thresholds or responses to the specialised temperature bars and to investigate whether early morning salivary cortisol levels differs between patients with unilateral sciatica and pain-free volunteers. participants will be required to salivate into a test tube. The sample will be processed at the Institute of Medical and Veterinary Sciences. Cortisol levels and measures of depression will be tested in the statistical modelling. Statistical software used will likely be SAS or R.
Timepoint [9] 296114 0
2x early morning salivary cortisol. 1x on awakening and 1x 30 mins post awakening

Eligibility
Key inclusion criteria
GENERAL:

Having both upper and lower limbs present

Must be suffering from unilateral sciatica for a minimum of 3 months*

Average daily pain score over previous week of more than/equal to 40 on the 100mm VAS scale*

In good general health without clinically significant renal, hepatic, cardiac, or other disease, as determined by the Principal Investigator

*does not apply to pain-free volunteers

Pain-free:

Must not have clinically significant pain condition

Must not be suffering from any condition or taking any medication which may be associated with neuropathic or central processing (e.g. diabetes)

Unilateral sciatica on CHRONIC opioid therapy:

Experience pain 5 days/week for at least 3 months

Ongoing opioid therapy at a dose equivalent to morphine 20 mg/day for more than 3 months without recent (1 month) dose change

Allowed to take non-opioid pain medications without recent (1 month) dose change

Unilateral sciatica NOT on opioid therapy:

Except codeine less than 30 mg/day

Allowed to take non-opioid pain medications without recent (1 month) dose change
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant or breastfeeding

2. Inadequate veins for blood sampling

3. Significant scarring on the planned site/s of investigation

4. Have an active inflammatory process (e.g. acute pain other than sciatic pain, influenza, active infection, rheumatoid arthritis etc.)

5. Have had a clinically significant infection in the 4 weeks prior to day 1

6. Taking any immunosuppressant drugs e.g. azathioprine, methotrexate, cyclosporine

7. Taking any oral or inhaled corticosteroid medicationsb

8. Sensory deficits at the QST site resulting from medical conditions, such as diabetes; alcoholic neuropathy; severe thyroid, liver or kidney diseases

9. Recent (within 8 weeks prior to day 1) interventional pain management procedures that may alter QST responses including neuraxial or local anaesthetic block to the affected area

10. Recent use of opioids (e.g. morphine use within 1 week, or codeine use (>30mg) within last 5 days)**

11. Change in pain medication dose/type/frequency within 4 weeks of day 1*

12. Use of anxiolytics, anti-depressants and anti-epileptic medications

13. Presence of non-prescribed drugs of abuse in urine drug screen. Enrolment of any participant who returns a positive result will be at the Investigators discretion

14. Suffers from a clinically diagnosed major psychiatric disorder, such as major depression, bipolar disorder, schizophrenia, anxiety disorder, and psychosis

15. A positive breath alcohol concentration (BAC) prior to the testing sessions

16. History of excessive use of alcohol, defined as more than
21 units of alcohol per week for females, and more than 28 units of alcohol per week for males

17. Known history of Hep B, Hep C, or HIV

18. Known disorder of thermal pain sensitivity e.g. Raynaud’s phenomenon

19. Inability to tolerate study procedures at screening familiarisation session

* Does not apply to pain-free volunteers.
** Excluding unilateral sciatica participants on opioid therapy

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/03/2012
Actual
20/03/2012
Date of last participant enrolment
Anticipated
Actual
18/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5010 0
5000

Funding & Sponsors
Funding source category [1] 284723 0
University
Name [1] 284723 0
The Pain and Anaesthesia Research Clinic, The University of Adelaide
Country [1] 284723 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] 283621 0
None
Name [1] 283621 0
Address [1] 283621 0
Country [1] 283621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286731 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 286731 0
Ethics committee country [1] 286731 0
Australia
Date submitted for ethics approval [1] 286731 0
09/07/2013
Approval date [1] 286731 0
11/07/2013
Ethics approval number [1] 286731 0
110506c

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33786 0
Prof Paul Rolan
Address 33786 0
Level 5, Medical School North, Medical School, Frome Road, Adelaide, 5005, SA, Australia
Country 33786 0
Australia
Phone 33786 0
+61 8 8313 4102
Fax 33786 0
Email 33786 0
[email protected]
Contact person for public queries
Name 17033 0
Nicole Sumracki
Address 17033 0
Discipline of Pharmacology, School of Medical Sciences
Level 5, Medical School North
Frome Road, Adelaide, South Australia, 5005
Country 17033 0
Australia
Phone 17033 0
+61 (0)8 8303 5188
Fax 17033 0
+61 (0)8 8224 0685
Email 17033 0
[email protected]
Contact person for scientific queries
Name 7961 0
Nicole Sumracki
Address 7961 0
Discipline of Pharmacology, School of Medical Sciences
Level 5, Medical School North
Frome Road, Adelaide, South Australia, 5005
Country 7961 0
Australia
Phone 7961 0
+61 (0)8 8303 5188
Fax 7961 0
+61 (0)8 8224 0685
Email 7961 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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