Randomized Double-blind Study Comparing the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Weekly mean pain intensity in study phase I (Visual analogue score, units 1-10)
研究概览
简要总结
Objective:
The objective of this study is to compare the efficacy of duloxetine in the treatment of patients with chronic low back pain with a radicular component to placebo.
Study hypothesis:
Duloxetine is a new substance now in use for the treatment of neuropathic pain. It has proven its efficacy in diabetic peripheral neuropathy and fibromyalgia in several trials. The investigators therefore hypothesize that duloxetine will be efficacious in patients with chronic low back pain and a radicular component.
Study Rationale:
Chronic low back pain is an extremely common diagnosis. However, therapeutic options for the condition are limited and therapy remains difficult. Duloxetine has proven its efficacy in patients with neuropathic pain and may also be useful in chronic low back pain. If the investigators are able to show a benefit for patients in the duloxetine arm, the substance may constitute a further treatment alternative in chronic low back pain.
Study Design:
Prospective, randomized, double-blind placebo-controlled cross over study. Patients will be administered duloxetine for 4 weeks followed by a 2 week wash-out phase after which they will be medicated with placebo for 4 weeks. A second group of patients will receive the medication in reversed order. The primary study endpoint is constituted the weekly mean of VAS-Score in the last week of each treatment period. Secondary endpoints are defined as use of rescue medication, Beck Depression Inventory score, Health related Quality of Life SF-36 score and side effects/adverse events.
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
- •Low back pain ( below L1)
- •Chronic pain, >6 months
- •Visual Analogue Scale (VAS) ≥ 5
- •Back pain with radicular component defined as pain with a burning, tingling sensation within the anatomic distribution of the nerve root and diagnosed by painDETECT questionnaire
- •Failed back surgery
排除标准
- •Current mood disorder (dysthymia, bipolar mood disorder)
- •Major Depression > 12 months (Beck Depression Inventory Score ≥ 18)
- •History of a psychoactive substance use disorder within the preceding 12 months
- •Major coexisting medical illness (e.g. severe heart failure, pulmonary hypertension, renal insufficiency)
- •Acute myocardial infarction
- •uncontrolled hypertension
- •Prostate hyperplasia
- •History of convulsion
- •Pregnancy; women of childbearing age will be required to use contraceptives during the duration of the study. Furthermore a pregnancy test will be performed prior to the beginning of the study and once a month during the study period.
- •Participation in a clinical trial in the 3 weeks preceding the study
- •Allergy to study medication
- •Use of the following medication:
- •opioids except for tramadol,
- •benzodiazepines other than indicated at low doses for sleep disorders
- •antineuropathic medication including except for that specified in the study protocol
- •muscle relaxants
- •antidepressants other than indicated at low doses for sleep disorders
- •NSAID, Paracetamol
- •non-selective MAO-Inhibitors
- •Fluvoxamine, Ciprofloxacin, Enoxacin
- •Selective Serotonin-reuptake Inhibitors (SSRI)
- •if tapering of these drugs is impossible before inclusion.
- •Impaired kidney function (Creatinine > 1.5mg/dl)
- •Impaired hepatic function (GOT, GPT >2 fold standard levels)
- •Patients who are not able to understand the study measures and are not able to complete pain assessment forms.
研究组 & 干预措施
Milk powder pill
Patients will receive 2 placebo pills per day for a period of 4 weeks.
干预措施: Duloxetine (Drug)
Duloxetine
In the experimental arm of the study patients will receive duloxetine, which will be titrated up to a dosage of 120mg over a period of two weeks and continued at this dosage for two weeks.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Weekly mean pain intensity in study phase I (Visual analogue score, units 1-10)
时间窗: Week 4 of study period
Operationally a VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end (left= no pain, right=worst imaginable pain).The patient marks the current subjective pain intensity on the scale. This is converted to a numeric value by measurement from the left side of the scale. (Units 1-10)
Weekly mean pain intensity in study phase II (Visual analogue score, units 1-10)
时间窗: Week 10 of study period
次要结局
- Health related Quality of Life SF-36 score in phase I of study period(Health related Quality of Life SF-36 score at week 4 of study period.)
- Use of rescue medication in phase II of study period(Use of rescue medication in week 10 of study period.)
- painDetect score in phase II of study period(painDetect score at week 10 of study period.)
- Beck Depression Inventory score in phase II of study period(Beck Depression Inventory score at week 10 of study period.)
- Use of rescue medication in study phase I(Use of rescue medication in week 4 of study period)
- Beck Depression Inventory score in phase I of study period(Beck Depression Inventory score at week 4 of study period)
- painDetect score in phase I of study period(painDetect score at week 4 of study period.)
- Health related Quality of Life SF-36 score in phase II of study period.(Health related Quality of Life SF-36 score at week 10 of study period.)
研究者
Sibylle Pramhas
MD
Medical University of Vienna