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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02774109
Enrollment
29
Registered
2016-05-17
Start date
2016-12-31
Completion date
2017-11-30
Last updated
2018-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

low back pain, fish oil, omega 3

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.

Interventions

DIETARY_SUPPLEMENTFish oil

Five 1000mg fish oil soft capsules per day (each capsule containing 350mg EPA and 250mg DHA) for 8 weeks

DIETARY_SUPPLEMENTPlacebo

Five 1000mg sunflower oil soft capsules per day for 8 weeks

PROCEDUREHotpacking

Hotpacking 15min on low back, three times a week for 8 weeks

PROCEDURETranscutaneous electrical nerve stimulation (TENS)

Transcutaneous electrical nerve stimulation (TENS) 15min on low back, three times a week for 8 weeks

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
100mm Visual Analogue Scale (VAS)Week 8 (T2)Assess low back pain intensity (current, least and worst in the past one week)

Secondary

MeasureTime frameDescription
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
Biering-Sorenson testBaseline (T0), Week 4 (T1), Week 8 (T2)Assess back extensor endurance
Occupational burnout inventoryBaseline (T0), Week 4 (T1), Week 8 (T2)Assess objective occupational burnout feeling
Pressure pain thresholdBaseline (T0), Week 4 (T1), Week 8 (T2)Assess pressure pain threshold with pressure algometer at quadratus lumborum and sacroiliac joint
Blood test: ESRBaseline (T0) and Week 8 (T2)Draw 10ml blood for checking the level of ESR
Blood test: hs-CRPBaseline (T0) and Week 8 (T2)Draw 10ml blood for checking the level of hs-CRP
100mm Visual Analogue Scale (VAS)Baseline (T0), Week 4 (T1)Assess low back pain intensity (current, least and worst in the past one week)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026