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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

Tracking Information
First Submitted Date  ICMJE May 10, 2016
First Posted Date  ICMJE May 17, 2016
Last Update Posted Date June 7, 2018
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
100mm Visual Analogue Scale (VAS) [ Time Frame: Week 8 (T2) ]
Assess low back pain intensity (current, least and worst in the past one week)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • 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
  • 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
  • Biering-Sorenson test [ Time Frame: Baseline (T0), Week 4 (T1), Week 8 (T2) ]
    Assess back extensor endurance
  • Occupational burnout inventory [ Time Frame: Baseline (T0), Week 4 (T1), Week 8 (T2) ]
    Assess objective occupational burnout feeling
  • 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)
  • Blood test: ESR [ Time Frame: Baseline (T0) and Week 8 (T2) ]
    Draw 10ml blood for checking the level of ESR
  • Blood test: hs-CRP [ Time Frame: Baseline (T0) and Week 8 (T2) ]
    Draw 10ml blood for checking the level of hs-CRP
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
  • 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
  • Lumbar range of motion [ Time Frame: Baseline (T0), Week 4 (T1), Week 8 (T2) ]
    Assess lumbar range of motion in flexion/extension with tape measure
  • 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
  • Identification pain questionnaire [ Time Frame: Baseline (T0), Week 4 (T1), Week 8 (T2) ]
    Assess low back pain characteristics with Chinese version of Identification pain questionnaire
  • Biering-Sorenson test [ Time Frame: Baseline (T0), Week 4 (T1), Week 8 (T2) ]
    Assess back extensor endurance
  • The Health and Work Performance Questionnaire (HPQ) [ Time Frame: Baseline (T0), Week 4 (T1), Week 8 (T2) ]
    Assess objective work performance with Taiwan version of The Health and Work Performance Questionnaire
  • Occupational burnout inventory [ Time Frame: Baseline (T0), Week 4 (T1), Week 8 (T2) ]
    Assess objective occupational burnout feeling
  • Athens Insomnia Scale [ Time Frame: Baseline (T0), Week 4 (T1), Week 8 (T2) ]
    Assess sleeping quality with Taiwan version of Athens Insomnia Scale
  • 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)
  • Blood test: ESR [ Time Frame: Baseline (T0) and Week 8 (T2) ]
    Draw 10ml blood for checking the level of ESR
  • Blood test: hs-CRP [ Time Frame: Baseline (T0) and Week 8 (T2) ]
    Draw 10ml blood for checking the level of hs-CRP
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain
Official Title  ICMJE The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Dietary Supplement: Fish oil
    • Procedure: Hotpacking
    • Procedure: Transcutaneous electrical nerve stimulation (TENS)
  • 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
    Interventions:
    • Dietary Supplement: Placebo
    • Procedure: Hotpacking
    • Procedure: Transcutaneous electrical nerve stimulation (TENS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2018)
29
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2016)
52
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02774109
Other Study ID Numbers  ICMJE FishOilonCNLBP201604
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tsung-Hsun Yang, MD Kaohsiung Chang Cung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP