The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- 100mm Visual Analogue Scale (VAS)
研究概览
简要总结
Objectives:
To investigate the efficacy of omega-3 polyunsaturated fatty acids (PUFA) on patients with chronic nonspecific low back pain (NLBP).
Methods and Materials:
Twenty-nine patients with chronic NLBP were randomly divided into experimental and control groups. For 8 weeks, participants in the experimental group received omega-3 PUFA at 3000 mg/day plus physical therapy, while those in the control group received placebo plus physical therapy. The visual analog pain scale, pressure algometer, Biering-Sorenson test, Roland-Morris Low Back Pain and Disability Questionnaire (RMQ), and occupational burnout inventory (OBI) were used in assessments at baseline (T0) and after 4 (T1) and 8 weeks (T2). Serum erythrocyte sedimentation rate (ESR) and hypersensitive C-reactive protein (hs-CRP) were checked at baseline and T2.
详细描述
Low back pain is a common symptom in modern society. However, nearly 85% of those who seek medical care for low back pain have no specific history and no specific finding in image study, and therefore do not receive a specific diagnosis. This type of low back pain is termed "nonspecific low back pain." Fish oil contains omega-3 polyunsaturated fatty acid, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). EPA and DHA can reduce the synthesis of prostaglandin E2. They are also the precursors of the E-resolvin and D-resolvin that suppress inflammatory cytokine production and act to resolve inflammation. Several previous studies showed that fish oil has the effect of anti-inflammation and pain reduction without side effect that affecting stomach and renal function. Therefore, fish oil is considered a new type of NSAID, and many studies are investigating its effect of anti-inflammation and pain reduction on different diseases. The purpose of this study is to investigate the effects of fish oil on patients with chronic nonspecific low back pain.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged 20-50
- •Low back pain duration over 3 months and pain intensity over 40mm when assessed with 100mm VAS
排除标准
- •History of major trauma or surgery at back
- •Obvious spinal pathology on plain film (e.g. scoliosis, spondylosis, spondylolisthesis)
- •Not suitable for taking fish oil or receiving physical modality treatment
- •Having other inflammatory disease (e.g. rheumatic arthritis, endometriosis, ankylosing spondylitis, infection)
- •Pregnancy
- •Regularly taking fish oil or fatty fish more than 2 times per week
- •Having coagulopathy or currently taking anti-coagulation agent
- •Receiving oral or topical NSAID in the past one week
- •Taking oral corticosteroid in the past 6 weeks
- •Receiving local injection of corticosteroid or prolotherapy in the past 3 months
结局指标
主要结局
100mm Visual Analogue Scale (VAS)
时间窗: Week 8 (T2)
Assess low back pain intensity (current, least and worst in the past one week)
次要结局
- Roland Morris Low Back Pain and Disability Questionnaire (RMQ)(Baseline (T0), Week 4 (T1), Week 8 (T2))
- Blood test: hs-CRP(Baseline (T0) and Week 8 (T2))
- Pressure pain threshold(Baseline (T0), Week 4 (T1), Week 8 (T2))
- Occupational burnout inventory(Baseline (T0), Week 4 (T1), Week 8 (T2))
- Biering-Sorenson test(Baseline (T0), Week 4 (T1), Week 8 (T2))
- 100mm Visual Analogue Scale (VAS)(Baseline (T0), Week 4 (T1))
- Blood test: ESR(Baseline (T0) and Week 8 (T2))