Investigation of Temperature Perception in Patents with Unilateral Sciatica
- Conditions
- nilateral sciaticaNeurological - Other neurological disordersUnilateral sciaticaInjuries and Accidents - Other injuries and accidents
- Registration Number
- ACTRN12612000444886
- Lead Sponsor
- Professor Paul Rolan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method