By: Dr. Joseph L. Lee, MD
Abstract:
With the 3-month study of Oleia Oil on 70 experimental patients, we have noted improvements in their pain tolerance after the continuous medication for the duration of the study. Much so, adverse reactions were nil to none.We therefore conclude that Oleia Topical Oil could be used for symptoms of musculoskeletal disorder. Further study of its longer term effects on different musculoskeletal disorder could open the gates for more topical analgesic ointment useful and beneficial to our patients.
CLINICAL TRIAL
Effects Of Cetylated Fatty Acid Oil (OLEIA Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial Joseph L. Lee, MD Principal Investigator
April 2013
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
INTRODUCTION:
Musculoskeletal disorders such as low back pain, osteoarthritis (O.A.) and rheumatoid arthritis (R.A.) do not only cause discomfort but also hinders a person’s productivity. In many cases it can be debilitating, resulting to millions of lost income and revenues. Most patients seek consult because of the pain they experience affecting significantly their mobility and overall quality of life. Incidences coincide with increasing age and are found in every country.
According to the World Health Organization (WHO) in collaboration with the Bone and Joint Decade Initiative, joint diseases such as rheumatoid arthritis and osteoarthritis, low back pain and severe trauma are among the 150 musculoskeletal conditions affecting millions of people worldwide regardless of color, race or gender. Many of these individuals suffering from musculoskeletal disorders are elderly due direct or indirect from degenerative changes significantly affecting quality of life. Another group of population severely affected by musculoskeletal disorders is the main work force due to prolonged sitting behind a desk, repetitive movements and stress. Patients suffering from musculoskeletal disorders are also prone to early osteodegenerative changes, all of which affect overall productivity and eventually lead to loss of income due to absences, resignation from work or early retirement.
Current medications used for pain control are Non-Steroidal Anti- Inflammatory Drugs (NSAIDs), which are effective in controlling pain, and have been, and are still being used for a good couple of years now. Over the years, many studies have been done with the use of NSAIDs. It was found out that chronic use of NSAIDs is associated with a 10% risk of gastric or duodenal ulcers as well as kidney disease and central nervous system symptoms. Allergic reactions
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
from NSAIDs use are also well documented. More recent studies revealed there is also a significant increase in risk of developing cardiovascular diseases.
Cetylated Fatty Acids (CFA) control pain by directly or indirectly reducing or inhibiting inflammation and its processes. Several mechanisms on the action of Cetylated Fatty Acids (CFA) have already been identified that are responsible for pain control, among other benefits.
There are several pathways involving CFA in pain relief wherein the key factor is controlling inflammation and the processes involved either promoting or sustaining inflammation. Cetylated Fatty Acids have been found out to have a role in reduction of eicosanoid production, modulates immune system response to inflammatory mediators, inhibits endothelial activation, reduction in tissue response to cytokines, and also acts as surfactants between joints. All of the stated effects of CFA directly or indirectly prevent/control pain by controlling inflammation.
The underlying cause of the pain plays an important factor in pain relief. Inflammatory causes of pain may respond quickly than those with structural changes like in arthritic conditions. However, CFA also has a surfactant effect that acts as a lubricant between joints providing pain relief.
How chronic the patient is experiencing pain may influence pain relief. In acute pain, inflammation and its processes are just beginning and may be halted by application of CFA. While in chronic pain, there may already have a buildup of inflammatory mediators and structural changes may have occurred sustaining inflammation. Cetylated Fatty Acids however acts on different aspect of inflammation and controlling it, providing pain relief.
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
As a patient age, cellular and anatomical changes have occurred in the body affecting the body’s response to inflammation. Together with osteodegenerative changes, older people are more prone to pain and may be more chronic and harder to control.
RESEARCH METHODOLOGY:
This is a double-blind controlled trial using Cetylated Fatty Acids Oil as the test product and Virgin Coconut Oil as placebo to be applied directly on affected areas of the body of patients suffering from joint pains and muscle pains. A total of 100 patients will be enrolled in the study and will be randomly divided into two groups which will be given randomly assigned samples of the test product or placebo, the distribution of which are unknown to the investigator and the patients. Each patient will be evaluated before and after application of the assigned product.
Pain does not only cause discomfort. If severe enough, it can also hinder a person’s productivity and in many cases, it can be debilitating, resulting to millions of income and revenues lost. Non-Steroidal Anti-Inflammatory Drugs are often used to alleviate pain and help the individual return to normal daily activities. However, chronic use of pain medications can be a potential source of a wide array of other problems ranging from mild abdominal discomforts to upper gastrointestinal bleeding. It can also affect the urinary and hepatic systems among others. Allergic reactions to NSAIDs are also well known. There is a clear need for alternatives or adjuncts to treatment to lessen these adverse effects. Cetylated Fatty Acids, as of the moments has no known adverse effects except for some possible skin irritation in a few sensitive patients. Since the product is in a cetyl alcohol form, it has lipophilic nature that allows easy penetration to the skin
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
providing local action. Although there are studies abroad showing the beneficial effect of topically prepared Cetylated Fatty Acids in controlling pain and improving mobility, studies on Cetylated Fatty Acids on pro-inflammatory mediators are relatively new. Also, due to regional and racial differences, there is a clear need for local studies to determine the effect of Cetylated Fatty Acids on Asian populations.
OBJECTIVES:
GENERAL OBJECTIVES
To determine the effectiveness of OLEIA Topical Oil in alleviating pain among patients with musculoskeletal disorders.
To determine the improvement in degree of pain after applying OLEIA Topical Oil using Visual Analogue Scale.
To determine adverse reaction(s) from using OLEIA Topical Oil.
To determine patient degree of satisfaction from using OLEIA Topical Oil.
METHODOLOGY:
This will be a randomized controlled double blind trial that aims to determine the effectiveness of Cetylated Fatty Acids in relieving muscular and joint pains in patients with any form of musculoskeletal disorders.
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
Ambulatory patients presenting with any form of acute or chronic pain due to musculoskeletal disorders who will consent to the study will be included. Patients suffering from pains due to trauma which may or may not lead to fracture(s), infectious processes or malignancy will be excluded from the study.
Two groups will be needed for the study: the test group using Cetylated Fatty Acids and the control group using the placebo. Assuming that 60% of the subjects will respond to the study product and 40% to the placebo, with an alpha error of 0.05 and 80% power to detect a statistically significant difference, the required sample size per group is 130. Allowing for control of extraneous factors that can affect the true measure of the study product, subject that will be needed for the study is 326 which will be randomly divided to two groups with 163 subjects per group.
OLEIA Topical Oil is a combination of Cetylated Fatty Acids (Omega-3, 5, 9) in topical oil form with lavender essence. It is marketed with a trade name of OLEIA Topical Oil in 20mL, 50mL or 100mL bottle. A liberal amount of the product is to be applied where the pain is located.
Virgin Coconut Oil will serve as the placebo. A liberal amount of the placebo is to be applied where the pain is located.
All patients who will qualify for the research study will be informed and will be given the Patient Information Sheet and will be given an orientation about the research study. During the orientation, the research study will be discussed in more detail and patient’s questions and/or clarifications will be answered. The basic content of the orientation is already included in the Patient Information Sheet and the dialect used in the orientation is in a language understood by all attendees. After the orientation, those who are still willing to join the research
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
study will be asked to sign the Consent Form; their names will be logged in a log book and enrolled in the study. Each enrollee will be asked to fill up a Patient Survey Questionnaire (PSQ) to gather some information about the patient. After the random allocation procedure, each patient will be assigned either in the Cetylated Fatty Acids or placebo. Although there are equal numbers of CFA and placebo, through random allocation procedures, each bottle will be assigned a specific number. These numbers will indicate whether the bottle contains either Cetylated Fatty Acids or placebo. Only the third party will have the master list containing the codes for the products. Patients will be asked their baseline pain score using the Visual Analogue Scale (VAS) and will be recorded in the PSQ. Patients will then be asked to apply a liberal amount of the assigned treatment product where the pain is located. After using the assigned product each patient will be asked to fill out a Product Feedback Form about the product they used.
PATIENT FEEDBACK:
After using the assigned product, each patient will be asked to fill up a Patient Feedback Form to determine the overall satisfaction in using the product. Patient satisfaction of the product will also determine the likelihood the patient will use the product they have just tested.
ETHICAL CONSIDERATION:
There are no foreseeable problems with regard to ethics in the study; however, there is always the possibility of skin reaction(s). The use of the placebo can be justified since the patients will not be asked to stop their present treatment regimen/s or medication/s if he/she so desires.
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
DATA PRESENTATION:
|
April 2013 |
May 2013 |
June 2013 |
25 Experimental 25 Experimental 10 VCO Oil 10 VCO Oil
DESCRIPTIVE STATISTICS A. April 2013 Subjects
MALE FEMALE
Total
SINGLE MARRIED
WIDOW
Total
ELEMENTARY HIGHSCHOOL
COLLEGE
20 Experimental 10 VCO Oil
I.
|
EXPERIMENTAL 25 Pts. |
VCO OIL 10 Pts. |
Gender
106 15 4 25 10
5 1 15 8 5 1
25 10 5 0 10 2 10 8 25 10
Civil Status
Educational Attainment
Total
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
- May 2013 Subjects
MALE 147 FEMALE 11 3
Total 25 10
SINGLE 4 0 MARRIED 20 9 WIDOW 1 1
Total 25 10
ELEMENTARY 0 0 HIGHSCHOOL 5 0
COLLEGE 20 10
25 10
|
EXPERIMENTAL 25 Pts. |
VCO OIL 10 Pts. |
Gender
Civil Status
Educational Attainment
Total
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
- June 2013 Subjects
MALE 108 FEMALE 10 2
Total 20 10
SINGLE 0 0 MARRIED 20 2 WIDOW 0 8
Total 20 10
ELEMENTARY 0 0 HIGHSCHOOL 0 0
COLLEGE 20 10
20 10
|
EXPERIMENTAL 20 Pts. |
VCO OIL 10 Pts. |
Gender
Civil Status
Educational Attainment
Total
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
II.
VISUAL ANALOGUE SCALE
|
Participants |
PRE-TREATMENT |
POST-TREATMENT |
||
|
Month (APRIL) |
Pain Scale |
Month (APRIL) |
Pain Scale |
|
a.
b.
25
10
MALE 10 Average 6-8 FEMALE 15 Average 7-8
MALE 6 Average 8-10 FEMALE 4 Average 8-10
MALE 10 FEMALE 15
MALE 6 FEMALE 4
Average 2-4
Average 2-4 *Improved
Average 6-8
Average 8-10
*Least improvement
Experimental
Placebo
|
Participants |
PRE-TREATMENT |
POST-TREATMENT |
||
|
Month (MAY) |
Pain Scale |
Month (JUNE) |
Pain Scale |
|
a.
b.
25
10
MALE 14 Average 5-8 FEMALE 11 Average 8-10
MALE 7 Average 1-10 FEMALE 3 Average 6-8
MALE 14 FEMALE 11
MALE 7 FEMALE 3
Average 4-6
Average 3-6 *Improved
Average 8-10
Average 8-10 *Least improvement
Experimental
Placebo
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a.
b.
III.
20 MALE 10 FEMALE 10
10 MALE 8 FEMALE 2
Average 6-8 MALE Average 8-10 FEMALE
Average 6-8 MALE Average 5-8 FEMALE
10 Average 4-6 10 Average 4-6 *Improved
8 Average 6-8
2 Average 6-9
*Least improvement
Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
|
Participants |
PRE-TREATMENT |
POST-TREATMENT |
||
|
Month (JUNE) |
Pain Scale |
Month (JULY) |
Pain Scale |
|
Experimental
Placebo
DEGREE OF SATISFACTION: FEEDBACK FORM
|
Month (APRIL) |
Degree of Satisfaction |
Experimental
- 25 b. 10
- 25 b. 10
General Average = 3 *Satisfactory
General Average = 0
*No Change
General Average = 3-2 *Satisfactory
General Average = 0-1 *Poor
Placebo
|
Month (MAY) |
Degree of Satisfaction |
Experimental
Placebo
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
|
Month (JUNE) |
Degree of Satisfaction |
20
10
RESULTS:
General Average = 4-3 *Very Satisfactory
General Average = 0-1 *Poorly Satisfactory
Experimental
Placebo
We have a total of 70 randomized selected patients ranging from 20s to 60s for the experimental group. These were further divided into 25 patients each month. From the duration of April, May and June likewise, these patients were advised to continue the treatment application to at least one to two months to determine the effectivity of the medication. With regards to the control group, 30 randomized selected patients were subjected to application of Virgin Coconut Oil; they have been divided 20 each month to match the 25 selected experimental group. They were likewise advised to continue the usage of the medication for at least one to two months.
The whole research would center on the degree of improvement of pain with the use of the Visual Analogue Scale. We have to bear in mind that this is very subjective on the part of both subjects either experimental or control group. The Visual Analogue Scale is utilized by Pain Management Center in order to determine the degree of diminishing pain upon treatment of certain medications. The degree of satisfaction was also noted with the study. This is in preference with the application of medications via Patient Feedback Forms that were distributed after the treatment proper. Lastly, it is fairly important to take note of the adverse
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
effects of the application treatment of both experimental and control groups which could boost the utilization of the experimental medication in the future.
The results revealed the following: DEGREE OF PAIN IMPROVEMENT
- Pre-treatmentforthemonthofAprilshowedaveragepainscalefor10male patients at average of 6-8, while 15 female patients revealed average of 7-8 scores. These are for the experimental group. While for the control group, 6 male patients averaged 8-10 scores while the 4 female patients revealed average of 8-10 scores.
Post-treatment analysis showed the 10 male patients’ scores dropping from average of 2-4. Likewise, the 15 female patients dropped at average score of 2-4, showing improved scoring with regards to pain threshold. Whereas the control group, 6 males scored average of 6-8 while the 4 females averaged from 8-10. The control group showed less improvement and others got even worse.
- Pre-treatmentforthemonthofMayshowedaveragepainscalefor14males at 5-8 scores, while females scored at 8-10 for the experimental group. The control group covered 7 male patients with average of 7-10 and 3 female patients with 6-8 pain score.
Post-treatment analysis showed the 14 male to have lowered their pain scale to average of 4-6, while the 11 females improved their score from average of 3-6. The placebo group showed poor improvement: the 7 male patients showed worse score of 8-10 and the 3 females showed average of 8- 10. Both showing inferiority of the placebo as the material used for medication.
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
- Pre-treatmentforthemonthofJuneshowedaveragepainscalefor10male at 6-8 pain score, while 10 females showed average of 8-10 scores. The control group revealed 8 males at 6-8 pain score and 2 females with 5-8 score.
Post-treatment results showed improved score of 4-6 for both the 10 males and 10 females in the experimental group. The 8 males in the control group scored with no improvement at 6-8; the 2 females scored worse at 6- 9.
DEGREE OF SATISFACTION
Based on the feedback forms, all the 70 subjects under the experimental group expressed level of satisfaction on the treatment as “satisfactory” to “very satisfactory”. However, the 30 enrollees in the control group rated the treatment as “status quo” to “unsatisfactory”. The results were reflected based on the April, May and June feedbacks.
ADVERSE REACTIONS
During the course of the 3-month study, there was no apparent noticeable complaints by the experimental groups from the time the patient applied the medications until such time the duration of the study expires. No rashes, allergies, dermatoses, hypersensitivity reaction was noted. This proves to show that OLEIA Topical Oil is safe to use on the external surface of the skin as a topical analgesic for musculoskeletal disorders.
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
DISCUSSION/CONCLUSION:
With the 3-month study on OLEIA Topical Oil on 70 experimental clients, we have noted improvements in their pain tolerance after the continuous medication for the duration of the study. Much so, adverse reactions were nil to none. We therefore conclude that OLEIA Topical Oil could be used for symptoms of musculoskeletal disorders. Further study of its longer term effects on different musculoskeletal disorders could open the gates for more topical analgesic ointment useful and beneficial to our patients.
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Roelofs PDDM, Deyo RA, Koes BW, Scholten RJPM, van Tulder MW. Non-steroidal anti-inflammatory drugs for low back pain. Cochrane Database of Systematic Review 2008, Issue 1. Art. No.:CDOOO396. DOI:10.1002/14651858.CDOOO396.pub3.
Siegfried Mense Muscle Pain: Mechanisms and Significance. Dtsch Arztebl Int. 2008 March; 105(12): 214-219. Published online 2008 March 21. DOI:10.3238/artzebl.2008.0214.
Brill K. Chronic Inflammatory Pain Control with Omega-5 (Myristoleic Acid). Neuronet Institute, St. Wendel, Germany.
Kraemer WJ. Effect of a Cetylated Fatty Acid Topical Cream on Functional Mobility and Quality of Life of Patients with Osteoarthritis. J Rheumatol.2004 Apr; 31(4):767-74.
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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial April 2013
Medina Manuel F. Manual of Pallative Medicine; Second Edition 2007; Pages 122-130.
Walsh Carol T. Schwartz-Bloom Rachelle D. Levine’s Pharmacology: Drug Actions and Reactions; Seventh Edition 2005; Pages 260-261.
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Wilcox CM, Shalek KA, Colsonis G. Striking Prevalence of Over-the- Counter Nonsteroidal Anti-inflammatory Drug Use in Patients with Upper Gastrointestinal Hemorrhage. Arch Intern Med 1994; 154-5.
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