The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Dietary Supplement: Fish oil
* Dietary Supplement: Placebo
* Procedure: Hotpacking
* Procedure: Transcutaneous electrical nerve stimulation (TENS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female aged 20-50 Low back pain duration over 3 months and pain intensity over 40mm when assessed with 100mm VAS Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Participants in the experimental group will take fish oil (five 1000mg fish oil soft capsules per day, each capsule containing 350mg EPA and 250mg DHA) and receive physical modality treatment (hotpacking 15min and transcutaneous electrical nerve stimulation (TENS) 15min, three times a week) for 8 weeks | Dietary Supplement: Fish oil<br>* Five 1000mg fish oil soft capsules per day (each capsule containing 350mg EPA and 250mg DHA) for 8 weeks<br>* Other names: omega 3 polyunsaturated fatty acid;Procedure: Hotpacking<br>* Hotpacking 15min on low back, three times a week for 8 weeks<br>Procedure: Transcutaneous electrical nerve stimulation (TENS)<br>* Transcutaneous electrical nerve stimulation (TENS) 15min on low back, three times a week for 8 weeks<br>|
| Placebo Comparator: Control group<br>Participants in the control group will take placebo (five 1000mg sunflower oil soft capsules per day) and receive physical modality treatment (hotpacking 15min and transcutaneous electrical nerve stimulation (TENS) 15min, three times a week) for 8 weeks | Dietary Supplement: Placebo<br>* Five 1000mg sunflower oil soft capsules per day for 8 weeks<br>Procedure: Hotpacking<br>* Hotpacking 15min on low back, three times a week for 8 weeks<br>Procedure: Transcutaneous electrical nerve stimulation (TENS)<br>* Transcutaneous electrical nerve stimulation (TENS) 15min on low back, three times a week for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100mm Visual Analogue Scale (VAS) | Assess low back pain intensity (current, least and worst in the past one week) | Week 8 (T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold | Assess pressure pain threshold with pressure algometer at quadratus lumborum and sacroiliac joint | Baseline (T0), Week 4 (T1), Week 8 (T2) | 
| Roland Morris Low Back Pain and Disability Questionnaire (RMQ) | Assess the impact of low back pain on daily life with Taiwan version of Roland Morris Low Back Pain and Disability Questionnaire | Baseline (T0), Week 4 (T1), Week 8 (T2) | 
| Biering-Sorenson test | Assess back extensor endurance | Baseline (T0), Week 4 (T1), Week 8 (T2) | 
| Occupational burnout inventory | Assess objective occupational burnout feeling | Baseline (T0), Week 4 (T1), Week 8 (T2) | 
| 100mm Visual Analogue Scale (VAS) | Assess low back pain intensity (current, least and worst in the past one week) | Baseline (T0), Week 4 (T1) | 
| Blood test: ESR | Draw 10ml blood for checking the level of ESR | Baseline (T0) and Week 8 (T2) | 
| Blood test: hs-CRP | Draw 10ml blood for checking the level of hs-CRP | Baseline (T0) and Week 8 (T2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, fish oil, omega 3