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

NCT02774109 | Completed DMC

• 1 other identifier: FishOilonCNLBP201604
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

low back pain; fish oil; omega 3

Outcome Measures

Primary Outcomes (1)

• 100mm Visual Analogue Scale (VAS)

  Assess low back pain intensity (current, least and worst in the past one week)

  Week 8 (T2)

Secondary Outcomes (7)

• Pressure pain threshold

  Baseline (T0), Week 4 (T1), Week 8 (T2)

• Roland Morris Low Back Pain and Disability Questionnaire (RMQ)

  Baseline (T0), Week 4 (T1), Week 8 (T2)

• Biering-Sorenson test

  Baseline (T0), Week 4 (T1), Week 8 (T2)

• Occupational burnout inventory

  Baseline (T0), Week 4 (T1), Week 8 (T2)

• 100mm Visual Analogue Scale (VAS)

  Baseline (T0), Week 4 (T1)

Study Arms (2)

Experimental group

EXPERIMENTAL

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; Procedure: Hotpacking; Procedure: Transcutaneous electrical nerve stimulation (TENS)

Control group

PLACEBO COMPARATOR

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; Procedure: Hotpacking; Procedure: Transcutaneous electrical nerve stimulation (TENS)

Interventions

Fish oil DIETARY_SUPPLEMENT

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

Also known as: omega 3 polyunsaturated fatty acid

Experimental group

Placebo DIETARY_SUPPLEMENT

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

Control group

Hotpacking PROCEDURE

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

Control group; Experimental group

Transcutaneous electrical nerve stimulation (TENS) PROCEDURE

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

Control group; Experimental group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female aged 20-50
• Low back pain duration over 3 months and pain intensity over 40mm when assessed with 100mm VAS

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

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

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Fish Oils; Fatty Acids, Omega-3; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Tsung-Hsun Yang, MD

  Kaohsiung Chang Cung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 17, 2016
• Study Start: December 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: June 7, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)