The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain
- Conditions
- Chronic Low Back Pain
- Registration Number
- NCT02774109
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- Male and female aged 20-50
- Low back pain duration over 3 months and pain intensity over 40mm when assessed with 100mm VAS
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 100mm Visual Analogue Scale (VAS) Week 8 (T2) Assess low back pain intensity (current, least and worst in the past one week)
- Secondary Outcome Measures
Name Time Method Roland Morris Low Back Pain and Disability Questionnaire (RMQ) Baseline (T0), Week 4 (T1), Week 8 (T2) Assess the impact of low back pain on daily life with Taiwan version of Roland Morris Low Back Pain and Disability Questionnaire
Blood test: hs-CRP Baseline (T0) and Week 8 (T2) Draw 10ml blood for checking the level of hs-CRP
Pressure pain threshold Baseline (T0), Week 4 (T1), Week 8 (T2) Assess pressure pain threshold with pressure algometer at quadratus lumborum and sacroiliac joint
Occupational burnout inventory Baseline (T0), Week 4 (T1), Week 8 (T2) Assess objective occupational burnout feeling
Biering-Sorenson test Baseline (T0), Week 4 (T1), Week 8 (T2) Assess back extensor endurance
100mm Visual Analogue Scale (VAS) Baseline (T0), Week 4 (T1) Assess low back pain intensity (current, least and worst in the past one week)
Blood test: ESR Baseline (T0) and Week 8 (T2) Draw 10ml blood for checking the level of ESR
Trial Locations
- Locations (1)
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung city, Taiwan
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital🇨🇳Kaohsiung city, Taiwan