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

NCT ID: NCT02774109

Last Updated: 2018-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-11-30

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Fish oil

Intervention Type: DIETARY_SUPPLEMENT

Five 1000mg fish oil soft capsules per day (each capsule containing 350mg EPA and 250mg DHA) for 8 weeks

Hotpacking

Intervention Type: PROCEDURE

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

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type: PROCEDURE

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Hotpacking

Intervention Type: PROCEDURE

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

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type: PROCEDURE

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

Interventions

Fish oil

Five 1000mg fish oil soft capsules per day (each capsule containing 350mg EPA and 250mg DHA) for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Hotpacking

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

Intervention Type: PROCEDURE

Transcutaneous electrical nerve stimulation (TENS)

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

Intervention Type: PROCEDURE

Other Intervention Names

omega 3 polyunsaturated fatty acid

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsung-Hsun Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Chang Cung Memorial Hospital

Locations

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

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

FishOilonCNLBP201604

Identifier Type: -

Identifier Source: org_study_id