Low Dose Naltrexone for Treatment of Pain in Patients With Fibromyalgia - Effect Via a Central Mechanism? A Randomized, Double-blinded, Placebo-controlled, Crossover Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in pain scores (during rest, during household activity, during personal daily hygienic procedures)
研究概览
简要总结
This study evaluates the effect and mechanism of low dose naltrexone for treatment of pain in patients with fibromyalgia. It s a randomised, double-blinded, placebo-controlled, cross-over study.
The study takes place at The Multidisciplinary Pain Center in Grindsted.
详细描述
Fibromyalgia syndrome is a prevalent musculoskeletal disorder characterized by pain, profound fatigue, sleep disorder, mood disturbance etc. The prevalence is estimated to be 2-8%.
Treatment of pain in patients with fibromyalgia is often based on opioids. However, opioids may lead to tolerance, addiction and hyperalgesia and alternative treatments are therefore warranted.
Low dose naltrexone (3-5mg) (LDN) has shown promising results in the treatment of pain in patients with fibromyalgia, but there is a need for further research.
At the typical dose of naltrexone, 50 mg, it is an opioid antagonist. However LDN demonstrates analgesic and anti-inflammatory effects, possibly involving an antagonism of microglia in the CNS.
The investigators hypothesize, that LDN has a better pain relieving effect than placebo in in patients with fibromyalgia (FM). The investigators also hypothesize that LDN has a better effect upon experimentally induced pain in FM-patients, compared to placebo. A tentative mechanism is a central facilitation of the endogenous pain inbitory system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Widespread pain in patients with fibromyalgia (based on the above criteria)
- •Enrolled as a patient in one of the multidisciplinary pain clinics involved in the project
- •Inflammatory rheumatic disease (peripheral inflammation, including arthritis), must be excluded
- •Women must be treated with a contraceptive measure, if not menopausal
排除标准
- •Treatment with opioids (other analgesic treatments in stabile dose 14 days prior to study start are allowed)
- •Change in stabile treatment (p.n. paracetamol is allowed, but must be registered)
- •Pregnant/breastfeeding
- •Does not speak/understand Danish
- •Allergy to the ingredient
- •Severe liver impairment
- •Severe kidney impairment
- •Acute hepatitis
研究组 & 干预措施
Placebo
Placebo tablet
1 tablet a day for 21 days
干预措施: Placebo (Drug)
Low dose naltrexone
Low dose naltrexone 4.5 mg/tablet, 1 tablet a day for 21 days
干预措施: Low dose naltrexone (Drug)
结局指标
主要结局
Change in pain scores (during rest, during household activity, during personal daily hygienic procedures)
时间窗: Baseline: Day -2 to day 1 (baseline before treatment 1); Treatment 1: Day 19 to 21 ; Washout: Day 33 to 35 (baseline before treatment 2); Treatment 2: Day 54 to 56
The patient indicates using a questionnaire-based numerical rating scale (0 = no pain; 100 = worst imaginable pain) mean values of pain at rest, pain during household activity and pain during personal hygienic procedures in the preceding 24 hrs. The cumulated pain scores are used in the statistical analyses.
次要结局
- Pressure algometry (1 sq.cm probe)(Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56)
- Pain Catastrophizing Scale (PCS)(Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56)
- Pain DETECT(Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56)
- Hospital Anxiety and Depression Scale (HADS)(Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56)
- Plasma concentrations of naltrexone and β-Naltrexon(Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56)
- Fibromyalgia Impact Questionnaire Revised (FIQR)(Before baseline: Day -3; Treatment 1: Baseline (Day 1) + Day 14 + 21 ; Washout: Before baseline day -3; Treatment 2: Baseline (Day 35) + Day 49 + 56)
- Daily Sleep Interference Scale (DSIS)(Diary (Treatment 1: baseline (Day 1) to Day 21; Treatment 2: baseline (Day 35) to Day 56))
- Quantitative Sensory Testing (QST)(Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56)
- Adverse effects(Diary + Treatment 1: Baseline (day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56)
- Brief Pain Inventory - Short Form (BPI-SF) questionnaire(Before baseline: Day -3 to -1; Washout: Before baseline Day 32 to 34)
研究者
Mads Werner
MD, PhD, DMSc
Rigshospitalet, Denmark