Chronic Low Back PainNCT02774109
The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain
A study testing Fish oil, Hotpacking and Transcutaneous electrical nerve stimulation (TENS) in people with Chronic Low Back Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Fish oil, Hotpacking and Transcutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female aged 20-50
- Low back pain duration over 3 months and pain intensity over 40mm when assessed with 100mm VAS
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
About this study
Objectives:
To investigate the efficacy of omega-3 polyunsaturated fatty acids (PUFA) on patients with chronic nonspecific low back pain (NLBP).
Read more
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.
Read the 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
- Being tested
- Fish oil, Placebo, Hotpacking, Transcutaneous electrical nerve stimulation (TENS)
- Keywords
- low back pain, fish oil, omega 3
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDietary supplement
Also called omega 3 polyunsaturated fatty acid
Five 1000mg fish oil soft capsules per day (each capsule containing 350mg EPA and 250mg DHA) for 8 weeks
PlaceboDietary supplement
Five 1000mg sunflower oil soft capsules per day for 8 weeks
HotpackingProcedure or surgery
Hotpacking 15min on low back, three times a week for 8 weeks
Transcutaneous electrical nerve stimulation (TENS)Procedure or surgery
Transcutaneous electrical nerve stimulation (TENS) 15min on low back, three times a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Placebo; Procedure: Hotpacking; Procedure: Transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
100mm Visual Analogue Scale (VAS)
Assess low back pain intensity (current, least and worst in the past one week)
Measured: Week 8 (T2)
Secondary outcomes (7)
Pressure pain threshold
Assess pressure pain threshold with pressure algometer at quadratus lumborum and sacroiliac joint
Measured: Baseline (T0), Week 4 (T1), Week 8 (T2)
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
Measured: Baseline (T0), Week 4 (T1), Week 8 (T2)
Biering-Sorenson test
Assess back extensor endurance
Measured: Baseline (T0), Week 4 (T1), Week 8 (T2)
Occupational burnout inventory
Assess objective occupational burnout feeling
Measured: Baseline (T0), Week 4 (T1), Week 8 (T2)
100mm Visual Analogue Scale (VAS)
Assess low back pain intensity (current, least and worst in the past one week)
Measured: Baseline (T0), Week 4 (T1)
Blood test: ESR
Draw 10ml blood for checking the level of ESR
Measured: Baseline (T0) and Week 8 (T2)
Blood test: hs-CRP
Draw 10ml blood for checking the level of hs-CRP
Measured: Baseline (T0) and Week 8 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startDec 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsung-Hsun Yang, MD, Principal investigator, Kaohsiung Chang Cung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774109
- Sponsor's protocol ID
- FishOilonCNLBP201604
- Status last verified
- Jun 2018
- First submitted
- 10 May 2016
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT02774109
- Acronym / sponsor ID
- FishOilonCNLBP201604
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, fish oil, omega 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Fish oil, Procedure: Hotpacking, Procedure: Transcutaneous electrical nerve stimulation (TENS)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 |
| Control group | Placebo comparator | Dietary Supplement: Placebo, Procedure: Hotpacking, Procedure: Transcutaneous electrical nerve stimulation (TENS)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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and female aged 20-50
- Low back pain duration over 3 months and pain intensity over 40mm when assessed with 100mm VAS
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oilAlso: omega 3 polyunsaturated fatty acidFive 1000mg fish oil soft capsules per day (each capsule containing 350mg EPA and 250mg DHA) for 8 weeks | Dietary supplement | Experimental group |
| PlaceboFive 1000mg sunflower oil soft capsules per day for 8 weeks | Dietary supplement | Control group |
| HotpackingHotpacking 15min on low back, three times a week for 8 weeks | Procedure or surgery | Control group, Experimental group |
| Transcutaneous electrical nerve stimulation (TENS)Transcutaneous electrical nerve stimulation (TENS) 15min on low back, three times a week for 8 weeks | Procedure or surgery | Control group, Experimental group |
Primary outcome
100mm Visual Analogue Scale (VAS)
Time frame: Week 8 (T2)
Assess low back pain intensity (current, least and worst in the past one week)
7 secondary outcomes
Pressure pain threshold
Time frame: Baseline (T0), Week 4 (T1), Week 8 (T2)
Roland Morris Low Back Pain and Disability Questionnaire (RMQ)
Time frame: Baseline (T0), Week 4 (T1), Week 8 (T2)
Biering-Sorenson test
Time frame: Baseline (T0), Week 4 (T1), Week 8 (T2)
Occupational burnout inventory
Time frame: Baseline (T0), Week 4 (T1), Week 8 (T2)
100mm Visual Analogue Scale (VAS)
Time frame: Baseline (T0), Week 4 (T1)
Blood test: ESR
Time frame: Baseline (T0) and Week 8 (T2)
Blood test: hs-CRP
Time frame: Baseline (T0) and Week 8 (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
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Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsung-Hsun Yang, MD principal investigator
Kaohsiung Chang Cung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil, Hotpacking and Transcutaneous electrical nerve stimulation (TENS) in people with Chronic Low Back Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100mm Visual Analogue Scale (VAS) (time frame: Week 8 (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.