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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Dietary supplement: Fish oil; Procedure: Hotpacking; Procedure: Transcutaneous electrical nerve stimulation (TENS); Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung city, Taiwan, 833
    • Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; Five 1000mg fish oil soft capsules per day (each capsule containing 350mg EPA and 250mg DHA) for 8 weeks; Other Names: omega 3 polyunsaturated fatty acid; Procedure: Hotpacking; Hotpacking 15min on low back, three times a week for 8 weeks; Procedure: Transcutaneous electrical nerve stimulation (TENS); Transcutaneous electrical nerve stimulation (TENS) 15min on low back, three times a week for 8 weeks
Placebo Comparator: Control group; 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	Procedure: Hotpacking; Hotpacking 15min on low back, three times a week for 8 weeks; Procedure: Transcutaneous electrical nerve stimulation (TENS); Transcutaneous electrical nerve stimulation (TENS) 15min on low back, three times a week for 8 weeks; Dietary supplement: Placebo; Five 1000mg sunflower oil soft capsules per day for 8 weeks

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Tsung-Hsun Yang, MD, Kaohsiung Chang Cung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): June 7, 2018
• Last Update Submitted That Met QC Criteria: June 5, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: low back pain; omega 3; fish oil
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: FishOilonCNLBP201604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No