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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774109
• Other study ID #: FishOilonCNLBP201604
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: November 2017

Study information

• Verified date: June 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Dietary Supplement:
• Fish oil
Five 1000mg fish oil soft capsules per day (each capsule containing 350mg EPA and 250mg DHA) for 8 weeks
• 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
• Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS) 15min on low back, three times a week for 8 weeks

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital	Kaohsiung city

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	100mm Visual Analogue Scale (VAS)	Assess low back pain intensity (current, least and worst in the past one week)	Week 8 (T2)
Secondary	Pressure pain threshold	Assess pressure pain threshold with pressure algometer at quadratus lumborum and sacroiliac joint	Baseline (T0), Week 4 (T1), Week 8 (T2)
Secondary	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)
Secondary	Biering-Sorenson test	Assess back extensor endurance	Baseline (T0), Week 4 (T1), Week 8 (T2)
Secondary	Occupational burnout inventory	Assess objective occupational burnout feeling	Baseline (T0), Week 4 (T1), Week 8 (T2)
Secondary	100mm Visual Analogue Scale (VAS)	Assess low back pain intensity (current, least and worst in the past one week)	Baseline (T0), Week 4 (T1)
Secondary	Blood test: ESR	Draw 10ml blood for checking the level of ESR	Baseline (T0) and Week 8 (T2)
Secondary	Blood test: hs-CRP	Draw 10ml blood for checking the level of hs-CRP	Baseline (T0) and Week 8 (T2)