The effect of cetylated fatty acid supplementation on low back pain
| ISRCTN | ISRCTN30329617 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30329617 |
- Submission date
- 05/04/2024
- Registration date
- 23/05/2024
- Last edited
- 24/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Low back pain is the leading contributor to disability in the U.S. with causes including degeneration of the spine, spinal stenosis, spondylolisthesis, and disc herniation. Current first-line treatment includes the use of NSAIDs to calm inflammation, however, these anti-inflammatories have demonstrated significant results alongside notable side effects of renal toxicity, GI side effects, and ulcers. Second-line treatment can extend to opioids in severe cases, which are not recommended due to patient dependence and addiction. Lastly, surgical interventions, such as spinal fusion and disc replacement, are last resort yet have high risks of complications, occurrence of pain, and continued use of NSAIDs despite intervention. Cetylated fatty acids (CFA) have been used to treat arthritis and sports injuries, mainly in hip, knee, and shoulder patients, as they are believed to reduce pain by decreasing the secretion of leukotriene B4 from stimulated neutrophils. There is an opportunity to apply CFA treatment to low back pain, in hopes of decreasing inflammation and providing a more optimal treatment for those who have adverse reactions to NSAIDs, opioids, or surgical intervention. This study aims to evaluate the effect of CFA supplementation on chronic, axial low back pain in patients over the age of 21 years old.
Who can participate?
Patients aged 21 years old and over with axial back pain from facet degenerative joint disease for more than 3 months will be recruited from a single center
What does the study involve?
Participants will take an oral supplementation two times a day and wear a patch for eight hours each day, over 30 days. Patients will fill out the questionnaires before and after taking the supplement to determine if CFAs ease back pain.
What are the possible benefits and risks of participating?
The benefits of participating in this trial include potential remission of low back pain symptoms such as stiffness, aching, and ambulation with a low side-effect profile supplement (i.e. cetylated fatty acids). The supplement has been shown to not induce adverse events such as GI ulcers, bleeding, or renal insufficiency, which can be found in mainstay treatment options, such as NSAIDs.
Documented risks of utilizing cetylated fatty acid supplementation include the potential for GI discomfort (flatulence, bloating), anaphylaxis, or skin irritation, as well as a patient not experiencing remission of symptoms.
Where is the study run from?
PharmaNutra Spa, Italy
When is the study starting and how long is it expected to run for?
April 2023 to December 2023
Who is funding the study?
PharmaNutra Spa, Italy
Who is the main contact?
Dr Vijay Vad, a Sports Medicine and PM&R physician at the Hospital for Special Surgeries, vadv@hss.org
Contact information
Principal Investigator
Hospital for Special Surgery (HSS), 523 East 72nd Street, 9th Floor
New York
10021
United States of America
| Phone | +1 (212) 606-1306 |
|---|---|
| vadv@hss.edu |
Scientific
Hospital for Special Surgery (HSS), 535 East 70th Street
New York
10021
United States of America
| Phone | +1 (646) 797-8331 |
|---|---|
| madrazoa@hss.edu |
Public
Hospital for Special Surgery (HSS), 523 East 72nd Street, 9th Floor
New York
10021
United States of America
| Phone | +1 216-952-2747 |
|---|---|
| anjali.kashyap@osumc.edu |
Study information
| Study design | Prospective single-cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Home, Hospital, Medical and other records |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effect of cetylated fatty acid supplementation on low back facet joint arthritis |
| Study objectives | The Cetilar Back Pain System will act synergistically to reduce axial back pain from facet degenerative joint disease |
| Ethics approval(s) |
Approved 30/05/2023, Western Institutional Review Board (1019 39th Avenue SE Suite 120, Puyallup, WA, 98374, United States of America; +1 360-252-2500; clientservices@wirb.com), ref: 20230506 |
| Health condition(s) or problem(s) studied | Remediating chronic axial discogenic back pain |
| Intervention | This is a prospective observational study with 25 treated patients over the age of 21 years old with remediating chronic axial discogenic back pain, where patients will apply the Cetilar Back Pain System in two groups: 1. Cetilar stick oral formulation (Cetylated Fatty Acid 800mg - 10 ml) twice daily 2. Cetilar Patch (8 hours duration) every day for 30 days to analyze the effects of Cetylated Fatty Acid on low back pain |
| Intervention type | Supplement |
| Primary outcome measure | Low back symptoms and pain measured using the Roland Morris Disability Questionnaire (RMDQ) pre-supplement and post-supplement after 30 days |
| Secondary outcome measures | The following secondary outcome measures are assessed pre- and post-supplement after 30 days: 1. Pain measured using the Numeric Pain Rating Scale (NPRS) 2. Adverse events measured using patient medical records at the end of the study 3. Treatment failure measured using patient medical records at the end of the study |
| Overall study start date | 01/04/2023 |
| Completion date | 01/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 21 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 25 |
| Key inclusion criteria | 1. Aged 21 years old and over 2. Axial back pain from facet degenerative joint disease for more than 3 months |
| Key exclusion criteria | 1. Narcotic pain medication 2. Unwilling to follow study protocol 3. Pregnancy or currently breastfeeding 4. Low back pain from a traumatic injury 5. Currently using a pain patch (e.g lidocaine) |
| Date of first enrolment | 01/06/2023 |
| Date of final enrolment | 01/09/2023 |
Locations
Countries of recruitment
- United States of America
Study participating centre
New York
10021
United States of America
Sponsor information
Industry
Via Delle Lenze, 216/b
Pisa
56122
Italy
| Phone | +39 050 7846500 |
|---|---|
| info@pharmanutra.it | |
| Website | https://www.pharmanutra.it/en/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from the primary investigator, Dr Vijay Vad, vadv@hss.org. Raw data will be coded to avoid the identification of patients. Consent was both required and obtained from all participants. |
Editorial Notes
24/07/2025: The intention to publish date was changed from 31/03/2025 to 31/10/2025.
03/03/2025: The intention to publish date was changed from 01/12/2024 to 31/03/2025.
08/05/2025: Study's existence confirmed by the Western Institutional Review Board.
