Fatty acid dietary supplement for chronic low back pain
| ISRCTN | ISRCTN16509365 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16509365 |
- Submission date
- 26/04/2022
- Registration date
- 28/04/2022
- Last edited
- 18/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Approximately 8 out of 10 people worldwide will suffer from low back pain at some point in their life. Most of the episodes of low back pain resolve spontaneously, however, the subset of patients who continue to experience chronic symptoms is so large that it has been acknowledged as the most common cause of disability. Medical treatment for chronic low back pain consists of long-term use of anti-inflammatories and pain killers, that when used for long periods of time can cause severe adverse effects, injuring the stomach, liver, and kidneys. Cetylated fatty acids are a dietary supplement that has showed to decrease pain related to knee osteoarthritis as well as inflammatory markers in vitro. They are safe and rarely cause adverse effects when ingested for a long time. But there is no information regarding the effectiveness of cetylated fatty acids in improving pain and function related to low back pain. Therefore we have decided to conduct a pilot study to evaluate this.
The aim of this study is to evaluate the effectiveness of Cetylated Fatty Acids in reducing pain and improving function in patients with chronic lower back pain.
Who can participate?
Patients, both male and female, age 21 or older, suffering from low back pain for more than 3 months can participate in the study.
What does the study involve?
The study involves taking a dietary supplement that consists of Cetylated Fatty Acids for 1 month. Patients that participate in the study are going to be evaluated for pain and function using validated questionnaires, before starting the treatment and at the end of the month. Any adverse effects related to the dietary supplement are going to be evaluated and treated (if necessary) during the whole follow-up
What are the possible benefits and risks of participating?
The probable benefits of the dietary supplement are improving low back pain and decreasing disability related to the pain.
Risks of participating are rare, however, adverse effects related to the dietary supplement may occur. Some of these adverse effects may be allergic reactions, heartburn, nausea, vomiting, and diarrhea.
Where is the study run from?
The private practice of Dr Vijay B. Vad, New York City, NY, USA.
When is the study starting and how long is it expected to run for?
April 2022 to July 2022
Who is funding the study?
The Vad foundation, New York, NY, USA.
Who is the main contact?
Dr Antonio Madrazo-Ibarra, amadrazoi@live.com
Contact information
Principal Investigator
519 E 72nd St Suite 203
New York
10021
United States of America
 ORCID ID |
0000-0002-5167-6241 |
|---|---|
| Phone | +1 212 606 1306 |
| vadv@hss.edu |
Study information
| Study design | Prospective interventional cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | The effectiveness of cetylated fatty acids on pain and mobility in patients with chronic low back pain |
| Study objectives | A dietary supplement based on cetylate fatty acids will decrease pain and increase function in patients with chronic low back pain. |
| Ethics approval(s) | Approved 02/28/2022, WCG Institutional Review Board (1019 39th Ave., SE, Suite 120, Puyallup, WA 98374; +1 855-818-2289; clientservices@wcgirb.com), ref: 20220202, study number: 13291166 |
| Health condition(s) or problem(s) studied | Low back pain |
| Intervention | Patients with chronic low back pain will take 2 capsules twice a day of LipoCet (Cetylated Fatty Acids) 300mg for 1 month. |
| Intervention type | Supplement |
| Primary outcome measure | Patients' functionality based on the Oswestry Low Back Pain Disability Questionnaire (ODI) evaluated pre-treatment and after 1 month of initiating the dietary supplement. |
| Secondary outcome measures | 1. Low back pain based on the Numeric Pain Rating Scale (0-10) evaluated pre-treatment and after 1 month of initiating the dietary supplement. 2. Adverse effects related to the dietary supplement evaluated after 1 month of the treatment using a questionnaire. |
| Overall study start date | 27/04/2022 |
| Completion date | 30/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 35 |
| Key inclusion criteria | Patients over 21 years of age with low back pain for more than 3 months. |
| Key exclusion criteria | 1. Patients currently on narcotic pain medication 2. Patients unwilling to follow the study protocol 3. Pregnant or currently breastfeeding 4. Patients with low back pain from a traumatic injury 5. Patients currently using a pain patch (e.g. lidocaine) |
| Date of first enrolment | 01/05/2022 |
| Date of final enrolment | 30/06/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centre
New York City
10021
United States of America
Sponsor information
Charity
220 E 65th Street
New York
10065-6620
United States of America
| Phone | +1 212 606 1306 |
|---|---|
| vadv@hss.edu | |
| Website | http://www.nonprofitfacts.com/NY/Vad-Foundation.html#ixzz7DdLpHLeT |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study will be published in a medical journal. |
| IPD sharing plan | Raw data (coded to avoid identification of patients) will be shared with anyone upon request to the primary investigator. vadv@hss.edu |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/02/2023 | 18/08/2023 | Yes | No |
Editorial Notes
18/08/2023: Publication reference added.
17/05/2022: The ethics approval has been added.
27/04/2022: Trial's existence confirmed by Pharma Neutra SP
