Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile?
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- correlations between pain modulation and drug effect
研究概览
简要总结
Hypothesis:
Response to therapy in fibromyalgia can be improved by coupling of specific medications to the individual patterns of dysfunctional pain modulation. Individuals exhibit wide range of pain modulating capabilities that can be assessed by dynamic psychophysical testing. Those that exhibit less efficient endogenous analgesia and/or increased pain summation are known to be more prone to suffer from pain. Tailoring medications to compensate for the specific dysfunctioning modulatory mechanism will improve pain control.
详细描述
Plan Overview:
The study will be conducted as a double - blind research. After undergoing evaluation of pain processing as detailed in the protocol, patients recruited will be randomised to receive Douloxetine or Pregabalin, two medications with evidence - based efficacy in the treatment of the fibromyalgia syndrome. After the first week of the study, all patients recruited will receive active treatment with one of these two medications.
This project will recruit fibromyalgia patients. Those patients will be treated with either Duloxetine or Pregabalin, and follow up will be made on the response to treatment as well as for possible change in pain modulation.
Study population:
We plan that 40 fibromyalgia patients will complete the analgesic treatment phase for each of the two medications. Considering an expected drop out of 30-50%, 150 patients will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fibromyalgia patients. All patients will undergo physical examination and tender point evaluation to ascertain fulfillment of the ACR 1990 criteria for classification of fibromyalgia (Wolfe et al 1990) i.e. the presence of widespread pain lasting at least 3 months and the presence of tenderness in at least 11 of 18 tender points.
排除标准
- •Age below 18 and above 80
- •Patients with cognitive dysfunction precluding use of psychophysics, those who cannot communicate in Hebrew, abnormal renal function with creatinine above 1.5, and elevated liver enzymes >x3 upper limit. Since the duloxetine has the potential to act as both substrate and an inhibitor of cytochrome P4502D6 (CYP2D6) inhibiting, caution should be used when other CYP2D6 substrates and inhibitors (some tricyclic antidepressants and SSRIs) are coadministered with duloxetine (Skinner et al., 2003). Patients currently treated with Douloxetine, Pregabalin, Gabapentin, Milnacipran, amitryptiline or other SSRIs, NSRIs or tricyclic medications will not be recruited unless they consent to discontinue prior medications for three weeks before enrolment to the study. During this period the use of NSAIDS and common analgesic medication will be permitted.
- •Patients not currently treated with such medications can be recruited.
- •Patients suffering from chronic pain due to a known active malignancy or other localized cause (e.g. fracture, Herpes Zoster etc.) will not be recruited.
研究组 & 干预措施
Duloxetine
Initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 4 weeks. The assessing person will contact patients by phone every week during the treatment period to receive the pain score for the last 24 hours, so we will have an indication of the effect among patients will discontinue medication. Patients will be asked to visit the clinic during the last week of treatment, for assessment of clinical pain (questionnaires) and pain modulation.
干预措施: Duloxetine (Drug)
Duloxetine
Initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 4 weeks. The assessing person will contact patients by phone every week during the treatment period to receive the pain score for the last 24 hours, so we will have an indication of the effect among patients will discontinue medication. Patients will be asked to visit the clinic during the last week of treatment, for assessment of clinical pain (questionnaires) and pain modulation.
干预措施: Pregabalin (Drug)
Pregabalin
Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 4 weeks. Drug should not be taken with meals. Same protocol will be applied as for Duloxetine.
干预措施: Duloxetine (Drug)
Pregabalin
Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 4 weeks. Drug should not be taken with meals. Same protocol will be applied as for Duloxetine.
干预措施: Pregabalin (Drug)
结局指标
主要结局
correlations between pain modulation and drug effect
时间窗: 2 years
This will be explored for each stage, and in relation to clinical pain and the other pain variables such as hyperalgesia
次要结局
未报告次要终点