ACTRN12612000444886已完成未知
Do patients with unilateral sciatica respond differently to the hot and cold temperature sensation compared to pain-free volunteers?
Professor Paul Rolan0 个研究点目标入组 40 人开始时间: 2012年4月18日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
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