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Completed

NCT Number: NCT02774109

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.

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Key information

Conditions

Chronic Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

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

Placebo

Dietary Supplement

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

Hotpacking

Procedure

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

Transcutaneous electrical nerve stimulation (TENS)

Procedure

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

Primary outcomes

  1. 100mm Visual Analogue Scale (VAS)

    Time frame: Week 8 (T2)

    Assess low back pain intensity (current, least and worst in the past one week)

Secondary outcomes

  1. Pressure pain threshold

    Time frame: Baseline (T0), Week 4 (T1), Week 8 (T2)

    Assess pressure pain threshold with pressure algometer at quadratus lumborum and sacroiliac joint

  2. Roland Morris Low Back Pain and Disability Questionnaire (RMQ)

    Time frame: 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

  3. Biering-Sorenson test

    Time frame: Baseline (T0), Week 4 (T1), Week 8 (T2)

    Assess back extensor endurance

  4. Occupational burnout inventory

    Time frame: Baseline (T0), Week 4 (T1), Week 8 (T2)

    Assess objective occupational burnout feeling

  5. 100mm Visual Analogue Scale (VAS)

    Time frame: Baseline (T0), Week 4 (T1)

    Assess low back pain intensity (current, least and worst in the past one week)

  6. Blood test: ESR

    Time frame: Baseline (T0) and Week 8 (T2)

    Draw 10ml blood for checking the level of ESR

  7. Blood test: hs-CRP

    Time frame: Baseline (T0) and Week 8 (T2)

    Draw 10ml blood for checking the level of hs-CRP

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 17, 2016
Registry last updated
Jun 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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