None listed
Conditions
Brief summary
We wish to investigate whether patients with unilateral sciatica whom take chronic opioid therapy, patients with unilateral sciatica whom do not take opioid therapy and pain-free participants have different sensitivities to hot and cold temperature sensations.
Interventions
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 m
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
Sponsors
Professor Paul Rolan
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
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
Outcome results
None listed