Clinical trial NCT02774109: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: low back pain
fish oil
omega 3
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 100mm Visual Analogue Scale (VAS)
timeFrame: Week 8 (T2)
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: Baseline (T0), Week 4 (T1), Week 8 (T2)
measure: Roland Morris Low Back Pain and Disability Questionnaire (RMQ)
timeFrame: Baseline (T0), Week 4 (T1), Week 8 (T2)
measure: Biering-Sorenson test
timeFrame: Baseline (T0), Week 4 (T1), Week 8 (T2)
measure: Occupational burnout inventory
timeFrame: Baseline (T0), Week 4 (T1), Week 8 (T2)
measure: 100mm Visual Analogue Scale (VAS)
timeFrame: Baseline (T0), Week 4 (T1)
measure: Blood test: ESR
timeFrame: Baseline (T0) and Week 8 (T2)
measure: Blood test: hs-CRP
timeFrame: Baseline (T0) and Week 8 (T2)
Other outcomes:
Locations:
city: Kaohsiung city
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Kaohsiung Chang Cung Memorial Hospital
name: Tsung-Hsun Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: