search
Back to results

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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fish oil
Placebo
Hotpacking
Transcutaneous electrical nerve stimulation (TENS)
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, fish oil, omega 3

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pressure pain threshold
Assess pressure pain threshold with pressure algometer at quadratus lumborum and sacroiliac joint
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
Biering-Sorenson test
Assess back extensor endurance
Occupational burnout inventory
Assess objective occupational burnout feeling
100mm Visual Analogue Scale (VAS)
Assess low back pain intensity (current, least and worst in the past one week)
Blood test: ESR
Draw 10ml blood for checking the level of ESR
Blood test: hs-CRP
Draw 10ml blood for checking the level of hs-CRP

Full Information

First Posted
May 10, 2016
Last Updated
June 5, 2018
Sponsor
Chang Gung Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02774109
Brief Title
The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain
Official Title
The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
low back pain, fish oil, omega 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil
Other Intervention Name(s)
omega 3 polyunsaturated fatty acid
Intervention Description
Five 1000mg fish oil soft capsules per day (each capsule containing 350mg EPA and 250mg DHA) for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Five 1000mg sunflower oil soft capsules per day for 8 weeks
Intervention Type
Procedure
Intervention Name(s)
Hotpacking
Intervention Description
Hotpacking 15min on low back, three times a week for 8 weeks
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous electrical nerve stimulation (TENS)
Intervention Description
Transcutaneous electrical nerve stimulation (TENS) 15min on low back, three times a week for 8 weeks
Primary Outcome Measure Information:
Title
100mm Visual Analogue Scale (VAS)
Description
Assess low back pain intensity (current, least and worst in the past one week)
Time Frame
Week 8 (T2)
Secondary Outcome Measure Information:
Title
Pressure pain threshold
Description
Assess pressure pain threshold with pressure algometer at quadratus lumborum and sacroiliac joint
Time Frame
Baseline (T0), Week 4 (T1), Week 8 (T2)
Title
Roland Morris Low Back Pain and Disability Questionnaire (RMQ)
Description
Assess the impact of low back pain on daily life with Taiwan version of Roland Morris Low Back Pain and Disability Questionnaire
Time Frame
Baseline (T0), Week 4 (T1), Week 8 (T2)
Title
Biering-Sorenson test
Description
Assess back extensor endurance
Time Frame
Baseline (T0), Week 4 (T1), Week 8 (T2)
Title
Occupational burnout inventory
Description
Assess objective occupational burnout feeling
Time Frame
Baseline (T0), Week 4 (T1), Week 8 (T2)
Title
100mm Visual Analogue Scale (VAS)
Description
Assess low back pain intensity (current, least and worst in the past one week)
Time Frame
Baseline (T0), Week 4 (T1)
Title
Blood test: ESR
Description
Draw 10ml blood for checking the level of ESR
Time Frame
Baseline (T0) and Week 8 (T2)
Title
Blood test: hs-CRP
Description
Draw 10ml blood for checking the level of hs-CRP
Time Frame
Baseline (T0) and Week 8 (T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsung-Hsun Yang, MD
Organizational Affiliation
Kaohsiung Chang Cung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung city
ZIP/Postal Code
833
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs