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

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ClinicalTrials.gov Identifier: NCT02774109
Recruitment Status : Completed
First Posted : May 17, 2016
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Dietary Supplement: Fish oil Dietary Supplement: Placebo Procedure: Hotpacking Procedure: Transcutaneous electrical nerve stimulation (TENS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain
Actual Study Start Date : December 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
Drug Information available for: Fish oil

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 Name: 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
Dietary Supplement: Placebo
Five 1000mg sunflower oil soft capsules per day 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774109


Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung city, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Tsung-Hsun Yang, MD Kaohsiung Chang Cung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02774109    
Other Study ID Numbers: FishOilonCNLBP201604
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chang Gung Memorial Hospital:
low back pain
fish oil
omega 3
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms