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
 Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial
April 2013

Table of Contents

Introduction...…………………………………………………………... Page 3

Research Methodology.………………………………………………… 5

Objectives.………….....………………………………………………... 6

Methodology..……………………...………………………………….... 6

Patient Feedback.……...………………………………………………... 8

Ethical Consideration..…...……………………………………………... 8

Data Presentation…....…...……………………………………………... 9
Descriptive Statistics….…...……………………………………... 9
Visual Analogue Scale....…..……………………………………... 12
Degree of Satisfaction: Feedback Form..…….…………………... 13

Results..…………………….…………………………………………... 14
Degree of Pain Improvement..…………………………………... 15
Degree of Satisfaction...……………………………...…………... 16
Adverse Reactions..…………………………………………….... 16

Discussion/Conclusion...……………………………………………….. 17

Reference...……………………………………………………………... 17

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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

1. To determine the effectiveness of OLEIA Topical Oil in alleviating pain

among patients with musculoskeletal disorders.

2. To determine the improvement in degree of pain after applying OLEIA

Topical Oil using Visual Analogue Scale.

3. To determine adverse reaction(s) from using OLEIA Topical Oil.

4. 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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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
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DATA PRESENTATION:

April 2013 May 2013 June 2013

25 Experimental 25 Experimental 20 Experimental

10 VCO Oil 10 VCO Oil 10 VCO Oil

I. DESCRIPTIVE STATISTICS

A. April 2013 Subjects

EXPERIMENTAL VCO OIL

25 Pts. 10 Pts.

a. Gender MALE 10 6
FEMALE 15 4

Total 25 10

b. Civil Status SINGLE 5 1

MARRIED 15 8

WIDOW 5 1

Total 25 10

c. Educational ELEMENTARY 5 0
Attainment HIGHSCHOOL 10 2
COLLEGE 10 8

Total 25 10

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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial
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B. May 2013 Subjects

EXPERIMENTAL VCO OIL

25 Pts. 10 Pts.

a. Gender MALE 14 7
FEMALE 11 3

Total 25 10

b. Civil Status SINGLE 4 0

MARRIED 20 9
WIDOW 1 1

Total 25 10

c. Educational ELEMENTARY 0 0
Attainment HIGHSCHOOL 5 0
COLLEGE 20 10

Total 25 10

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Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial
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C. June 2013 Subjects

EXPERIMENTAL VCO OIL

20 Pts. 10 Pts.

a. Gender MALE 10 8
FEMALE 10 2

Total 20 10

b. Civil Status SINGLE 0 0

MARRIED 20 2
WIDOW 0 8

Total 20 10

c. Educational ELEMENTARY 0 0
Attainment HIGHSCHOOL 0 0
COLLEGE 20 10

Total 20 10

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 Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial
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II. VISUAL ANALOGUE SCALE

PRE-TREATMENT POST-TREATMENT
Participants
Month Month
Pain Scale Pain Scale
(APRIL) (APRIL)

a. Experimental 25 MALE 10 Average 6-8 MALE 10 Average 2-4

FEMALE 15 Average 7-8 FEMALE 15 Average 2-4

*Improved

b. Placebo 10 MALE 6 Average 8-10 MALE 6 Average 6-8

FEMALE 4 Average 8-10 FEMALE 4 Average 8-10

*Least
improvement

PRE-TREATMENT POST-TREATMENT
Participants
Month Month
Pain Scale Pain Scale
(MAY) (JUNE)

a. Experimental 25 MALE 14 Average 5-8 MALE 14 Average 4-6

FEMALE 11 Average 8-10 FEMALE 11 Average 3-6

*Improved

b. Placebo 10 MALE 7 Average 1-10 MALE 7 Average 8-10

FEMALE 3 Average 6-8 FEMALE 3 Average 8-10

*Least improvement

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 Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial
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PRE-TREATMENT POST-TREATMENT
Participants
Month Month
Pain Scale Pain Scale
(JUNE) (JULY)

a. Experimental 20 MALE 10 Average 6-8 MALE 10 Average 4-6

FEMALE 10 Average 8-10 FEMALE 10 Average 4-6

*Improved

b. Placebo 10 MALE 8 Average 6-8 MALE 8 Average 6-8

FEMALE 2 Average 5-8 FEMALE 2 Average 6-9

*Least
improvement

III. DEGREE OF SATISFACTION: FEEDBACK FORM

Month (APRIL) Degree of Satisfaction

a. Experimental 25 General Average = 3

*Satisfactory

b. Placebo 10 General Average = 0

*No Change

Month (MAY) Degree of Satisfaction

a. Experimental 25 General Average = 3-2

*Satisfactory

b. Placebo 10 General Average = 0-1

*Poor

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 Effects Of Cetylated Fatty Acid Oil (Oleia Oil) In Alleviation Of Pain In Musculoskeletal Disorders: A Randomized Control Trial
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Month (JUNE) Degree of Satisfaction

a. Experimental 20 General Average = 4-3

*Very Satisfactory

b. Placebo 10 General Average = 0-1

*Poorly Satisfactory

RESULTS:

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-treatment for the month of April showed average pain scale for 10 male
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-treatment for the month of May showed average pain scale for 14 males
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
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 Pre-treatment for the month of June showed average pain scale for 10 male
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
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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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2. Siegfried Mense Muscle Pain: Mechanisms and Significance. Dtsch

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4. Kraemer WJ. Effect of a Cetylated Fatty Acid Topical Cream on

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5. Medina Manuel F. Manual of Pallative Medicine; Second Edition 2007;

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