Essential Oils and Delayed Onset Muscle Soreness; The Effects of Topical Mentha x Piperita and Eucalyptus Globulus Oils in the Older Adult and Elderly Population
Phase: NA
Conditions: Muscle Soreness
Sponsor: Rutgers, The State University of New Jersey

 
 
 
Protocol Title: Topical Eucalyptus globulus and Mentha x piperita on muscle soreness in older adults and the elderly 
Protocol Version Date: V3.03.20.21 
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INTERVENTIONAL 
RESEARCH PROTOCOL  
(HRP-503a) 
 
 
 
 
STUDY INFORMATION 
 
§ 
Title of Project: Essential oils and delayed onset muscle soreness in older adults and the 
elderly; The effects of topical Mentha x piperita and Eucalyptus globulus 
 
Principal Investigator Name: Zeeshan Khan, MD, FAAFP, CMD 
 
Principal Investigator Div. & Dept.: Department of Family and Community Medicine 
 
§ 
Principal Investigator Contact Info:  
zeeshan.khan.md@rutgers.edu; zkhan@centrastate.com  
597 Park Ave, Freehold, NJ 07728 
732-294-2540 
 
§ 
Protocol Version and Date: 
V3 03.20.21 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Protocol Title: Topical Eucalyptus globulus and Mentha x piperita on muscle soreness in older adults and the elderly 
Protocol Version Date: V3.03.20.21 
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Table of Contents 
Skip To Section: Hold CTRL + Click (Below) To Follow Link in Blue 
 
1.0 
Research Design 
 
 
1.1 
Purpose/Specific Aims 
 
 
1.2 
Research Significance 
 
 
1.3 
Research Design and Methods 
 
 
1.4 
Preliminary Data 
 
 
1.5 
Sample Size Justification 
 
 
1.6 
Study Variables 
 
 
1.7 
Drugs/Devices/Biologics 
 
 
1.8 
Specimen Collection 
 
 
1.9 
Data Collection 
 
 
1.10 Timetable/Schedule of Events 
 
 
2.0 
Project Management 
 
 
2.1 
Research Staff and Qualifications 
 
 
2.2 
Research Staff Training 
 
 
2.3 
Resources Available 
 
 
2.4 
Research Sites 
 
 
3.0 
Multi-Center Research 
 
 
4.0 
Subject Considerations 
 
 
4.1 
Subject Selection and Enrollment Considerations 
 
 
4.2 
Secondary Subjects 
 
 
4.3 
Number of Subjects 
 
 
4.4 
Consent Procedures 
 
 
4.5 
Special Consent Populations 
 
 
4.6 
Economic Burden and/or Compensation For Subjects 
 
 
4.7 
Risks of Harm/Potential for Benefits to Subjects to Subjects 
 
 
5.0 
Special Considerations 
 
 
5.1 
Health Insurance Portability and Accountability Act (HIPAA) 
 
 
5.2 
Family Educational Rights and Privacy Act (FERPA) 
 
 
5.3 
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
 
 
5.4 
General Data Protection Regulation (GDPR) 
 
 
5.5 
 NJ Access to Medical Research Act (Surrogate Consent)  
 
 
6.0 
Data Management Plan 
 
 
6.1 
Data Analysis 
 
 
6.2 
Data Security 
 
 
6.3 
Data Safety And Monitoring 
 
 
6.4 
Reporting Results 
 
 
6.5 
Secondary Use of the Data 
 
 
7.0 
Research Repositories – Specimens and/or Data 
 
 
8.0 
Approvals/Authorizations 
 
 
9.0 
Bibliography 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Protocol Title: Topical Eucalyptus globulus and Mentha x piperita on muscle soreness in older adults and the elderly 
Protocol Version Date: V3.03.20.21 
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1.0 Research Design 
 
1.1 Purpose/Specific Aims 
The purpose of this study is to find an alternative, low risk option for managing muscle 
soreness in the older adult and elderly population. 
 
A.  Objectives  
This study aims to compare how the topical application of essential oils Eucalyptus 
globulus and Mentha x piperita impact delayed onset muscle soreness after eccentric 
exercises compared to one another and to control.  
B.  Hypotheses / Research Question(s) 
It is hypothesized that application of Eucalyptus globulus or Mentha x piperita oil will 
reduce perceived muscle soreness in subjects compared to control.  
 
1.2 Research Significance 
Delayed onset muscle soreness (DOMS) is a common resultant of activity which 
exceeds one’s typical range. Its effects linger, often beginning 8 to 24 hours after 
activity and peaking within 24 to 48 hours of repetitive eccentric exercises. [1] Elite 
athletes must frequently cope with this during the peak of their training, but the average 
person also experiences its effects following the initiation of an activity regimen or an 
increase in their routine. It is thought that this phenomenon is multifactorial in nature, 
with proposed mechanisms including lactic acid retention, damage to connective tissue, 
and local inflammation. [2] Swelling due to influx of fluid and immune cells into muscle 
tissue is also a contributing factor. [1] There are a multitude of proposed management 
strategies for DOMS, ranging from pharmacological approaches like NSAIDs and 
analgesics, exercise, stretching, cryotherapy, transcutaneous electrical nerve 
stimulation, ultrasound, fish oils, caffeine, and antioxidants, among others. [1] These 
methods have varying efficacy and consistency in improving the effects of DOMS, and 
furthermore they each have their potential for adverse effects or lack of accessibility.  
Herbal and natural medicine has been around for many years, particularly in regard to 
inflammatory disorders and somatic symptoms. As more research into the efficacy of 
these alternative methods is performed, they become an even more viable option. 
Essential oils, through aromatherapy, topicals, or ingestion, have been employed for a 
wide variety of ailments including those of anti-bacterial, anti-oxidant, and anti-
inflammatory nature. [3] These oils are generally regarded as safe to use as well, as is 
proclaimed by the U.S. Food and Drug Administration, particularly when used at 
appropriate diluted concentrations topically when the risks are minimized further. [4] 
These oils might be a potential alternative or additive to usual management of muscle 
soreness, particularly in patient populations like the elderly who are more susceptible to 
the side effects of medications like NSAIDs.  

 
 
 
Protocol Title: Topical Eucalyptus globulus and Mentha x piperita on muscle soreness in older adults and the elderly 
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Oils under the genus Eucalyptus and Mentha have been shown to have anti-
inflammatory and analgesic properties. [5,6,7] Both have been shown to have inhibitory 
effects on nitrous oxide and reduce the activity of various inflammatory markers. [5,8] 
Eucalyptus globulus is predominantly comprised of 1,8-cineole, which can inhibit 
neutrophil migration and thereby reduce edema and inflammation. [9] Rodent studies 
have even shown that Eucalyptus may have antinociceptive effects similar to that of 
morphine [8], which is supported by the subjective pain relief it brought to patients 
following a total knee replacement. [10] Mentha x piperita has been studied for its 
topical analgesic effects in headache patients, and application appeared to help 
suppress temporal muscle activity. [11] Local application has been shown to have a 
cooling effect through alteration of the calcium channels for cool-receptors, which may 
be soothing. [12] With these benefits in mind, this study aims to identify and compare 
the effects of topical Eucalyptus globulus and Mentha x piperita oils in delayed onset 
muscle soreness in the older adult and elderly population.  
 
1.3 Research Design and Methods 
This study is designed as a randomized controlled interventional study with a rolling 
enrollment over the course of 6 months, with each individual subject’s participation 
spanning over 72 hours. 20 subjects will be recruited for participation. 10 subjects will be 
included in the Eucalyptus globulus intervention group, and the remaining 10 will be 
placed in the Mentha x piperita group. A blocked randomisation list will be generated 
using an online randomizer in order to allocate subjects to each treatment group 
randomly. Each subject will have one upper extremity serving as the control, and one 
upper extremity which receives the intervention. 
A. Research Procedures 
Subjects 
Subjects 50 years old and above with no previous resistance training sessions within 
the past year will be recruited at The Manor Health and Rehabilitation, a subacute 
rehabilitation and long-term care facility. A verbal explanation will be provided to the 
potential subjects by Dr Asselstine or Dr Shah on-site at the facility, including the fact 
that their care at the facility will not be affected by their decision to participate or not, 
and if they are interested in proceeding they will be asked to complete a survey 
regarding the subject’s demographics (gender, age, hand dominance), ensure there are 
no hypersensitivities to the oils being used, upper extremity injuries within 1 year, and 
that they have the functional capacity for exercise of 3.5 metabolic equivalents or 
greater based on the Duke Activity Status Index. Subjects will be required to sign a 
consent to participate in screening. If participants pass the screening process they will 
again be informed of the study and all potential risks/benefits prior to signing an 
informed consent to partake in research.  
Materials 

 
 
 
Protocol Title: Topical Eucalyptus globulus and Mentha x piperita on muscle soreness in older adults and the elderly 
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Eucalyptus globulus and Mentha x piperita essential oils will be obtained commercially 
from SunRose Aromatics (Morrill, Maine), and, individually, will be mixed with carrier oil 
for application. SunRose Aromatics is a recommended supplier from the RJ Buckle 
Clinical Aromatherapy for Health Professionals course. Fractionated coconut oil will be 
used as the carrier oil and also obtained from SunRose Aromatics. A 2% oil mixture for 
topical application will be made with essential oils diluted in fractionated coconut oil per 
guidelines from the RJ Buckle Clinical Aromatherapy for Health Professionals course 
recommendations. This mixture will be prepared directly before application of oils by Dr 
Asselstine or Dr Shah. The unmixed oils will be stored in a private room with no 
windows at room temperature at the Manor Health and Rehabilitation facility (689 W 
Main St, Freehold, NJ 07728).  
 
Intervention 
Participants will be divided equally into the Mentha x piperita or the Eucalyptus globulus 
group. A 2% oil mixture for topical application will be made with essential oils from 
SunRise Aromatics diluted in fractionated coconut oil per guidelines from the RJ Buckle 
Clinical Aromatherapy for Health Professionals course recommendations. Physician-
supervised eccentric exercise of the elbow flexors will be performed based on an 
adaptation of the method described by Weber. [14] Free weight dumbbells will provide 
resistance. The subject will be instructed to prolong the extension aspect of the curl to 
be five seconds long. They will repeat this motion for 10 or more repetitions until 
exhaustion, either due to the participant feeling they can no longer tolerate the five 
second eccentric aspect of the exercise or the investigator identifying that their form has 
faltered. If subjects reach exhaustion after the 10 repetitions minimum, they will rest for 
1 minute. If they are unable to complete 10 repetitions at this weight, the resistance will 
be decreased to the next lowest weight and they will continue until exhaustion. This will 
continue until subjects reach exhaustion with the lowest resistance weight. Immediately 
following exercise, the participants will have the respective oil applied topically to their 
left upper extremity by the investigator. Their right upper extremity will serve as the 
control and no essential oil will be applied. Investigators will apply the oil without any 
use of massage technique and to only apply very superficial pressure. This application 
will be repeated 8 hours after exercise, when DOMS has been known to initiate, and at 
24 hours after exercise, when DOMS may begin to peak.  
Subject Safety 
Vital signs will be measured prior to the initiation of exercise, including temperature, 
heart rate, blood pressure, and oxygen saturation. A physician will be notified of any 
abnormalities and the subject must be medically optimized prior to exercising. All 
exercise will be supervised by a physician. After the intervention is applied, subjects will 
be directly observed for 15 minutes by a physician to ensure no immediate adverse 
reactions occur. Vital signs will be repeated at the end of the observation period. 

 
 
 
Protocol Title: Topical Eucalyptus globulus and Mentha x piperita on muscle soreness in older adults and the elderly 
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Nursing staff will be on-site in their usual capacity and physicians available on-call 
throughout the duration of the study. Medications are available at the facility if needed 
for any adverse events.  
B. Data Points 
Subject outcomes will be based on a self-reported visual analog scale, which has 
previously been shown to have validity in subjectively quantifying perceived muscle 
soreness and used in prior studies. [14,16]. These outcomes will be recorded by 
investigators for both the intervention and control upper extremity at 24, 48, and 72 
hours post-exercise.  
C. Study Duration 
Each subject will participate in this study for 72 hours. The overall study is anticipated to 
take place over a six month duration.  
D. Endpoints 
The primary endpoint will be a self-reported perceived muscle soreness using a visual 
analog scale. There are no secondary endpoints.  
1.4 Preliminary Data 
N/A 
 
1.5 Sample Size Justification 
We anticipate a sample size of 20 subjects, 10 subjects in the Eucalyptus globulus group 
and 10 subjects in the Mentha x piperita group. This is based on previous studies which 
have investigated interventions for perceived muscle soreness and utilized a similar 
sample size for a power of 80% and a 1 tailed level of significance of p<0.05. [15] 
1.6 Study Variables 
A.   Independent Variables, Interventions, or Predictor Variables  
Independent variables are whether the subject receives topical application of Eucalyptus 
globulus oil or Mentha x piperita oil. Additionally, each subject will have an intervention 
extremity that receives the essential oil, and a control extremity which receives no 
treatment. The subjects will be aware of which group they are in, as there is no way to 
mask the fragrance.  
B.  Dependent Variables or Outcome Measures  
The dependent variable will be self-reported perceived muscle soreness based on a 
visual analog scale.  
 
1.7 Drugs/Devices/Biologics  
No drugs will be used during this investigation. Essential oils are not regulated under the 
U.S. Food and Drug Administration. The oils obtained commercially from SunRose 
Aromatics.   
  

 
 
 
Protocol Title: Topical Eucalyptus globulus and Mentha x piperita on muscle soreness in older adults and the elderly 
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1.8 Specimen Collection 
 No specimens will be collected.  
 
1.9 Data Collection 
 
A. Primary Data Collection 
Location: Data collection will occur at the Manor Health and Rehabilitation Center 
(689 W Main St, Freehold, NJ 07728). Permission has been granted by the 
director of this facility and by authorities with CentraState Healthcare System, 
which the Manor is owned by.  
§ Process of Data Collection: The investigators will oversee the collection of 
data in-person at the facility. Only Rutgers study staff will be involved in any 
research roles. Staff at the Manor Health and Rehabilitation will not be 
involved in the collection of data or treatment of subjects pertaining to this 
study, but will maintain their usual roles at the study site throughout the 
duration of this investigation.  
§ Timing and Frequency: Data collection will occur at the beginning of a 
subject’s participation in order to collect demographic information, and then at 
24, 48, and 72 hours following exercise to survey their perceived muscle 
soreness.  
§ Procedures for Audio/Visual Recording: There will be no recording of 
subjects.  
§ Study Instruments: Recruited subjects will complete a survey to collect 
demographic data, medical history, and allergies. Subjects will identify their 
perceived muscle soreness using a self-reported visual analog. They will 
complete this for both the control and intervention arm at 24, 48, and 72 hours 
post-exercise.  
§ Ethnographic Studies, Interviews, Or Observation: There will be no 
interviews or observational aspect to this study. 
§ Subject Identifiers: Each subject will be assigned to a random number 
associated with their name that will be stored in a password protected file on a 
secure drive. In a separate, also password protected, file the collected data 
will be stored with the associated subject’s number 
 
B. Secondary Data Collection: No secondary data collection will occur.   
 
1.10 Timetable/Schedule of Events 
T=0: Subjects perform supervised eccentric curl exercises.  
T=1: Subjects have the intervention and control oils applied topically to their proximal 
arms immediately after exercise is completed and are monitored for 15 minutes.  
T=1+ 8hrs: Subjects have a second application of the intervention and control oils applied 
topically to their arms.  

 
 
 
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T=1+ 24hrs: Subjects have a third application of the intervention and control oils applied 
topically to their arms. They complete the visual analog survey for perceived DOMS. 
T=1+ 48hrs: Subjects complete the visual analog survey for perceived DOMS again.  
T=1+ 72hrs: Subjects complete the visual analog survey for perceived DOMS for the final 
time.  
 
2.0 Project Management 
 
2.1 Research Staff and Qualifications 
The research investigators consist of two board certified family medicine and geriatric 
physicians, Drs. Zeeshan Khan and Joshua Raymond. Both physicians are faculty 
within the Department of Family and Community Medicine at Rutgers. The team also 
consists of two resident physicians within the Rutgers RWJMS at CentraState Family 
Medicine Program, Dr Sydney Asselstine and Dr Anand Shah. Dr Shah will be 
transitioning into the geriatrics fellowship position through Rutgers RWJMS at 
CentraState for the 2021-2022 academic year. A certified aromatherapist will be 
available in consult for additional recommendations regarding the essential oils but will 
not be directly involved in any research activities. Each investigator has familiarity with 
the study site and patient population from working in this community.  
2.2 Research Staff Training 
All research staff will undergo a briefing of the protocol for this particular study and their 
respective roles. All investigators will be notified of any updates in protocol or 
procedures. All investigators have undergone CITI training.  
2.3 Resources Available 
At the facility there is a rehabilitation room available and weights that can be used to 
provide resistance for the exercise. There is also 24/7 nursing staff and physicians on-
call that can assist in the event of any adverse consequences to participants. There is a 
medication room available that would have appropriate treatments for potential adverse 
outcomes such as rashes.  
 
2.4 Research Sites 
The research will occur at the Manor Health and Rehabilitation facility (under 
CentraState Medical Center, 689 W Main St, Freehold, NJ 07728), and the data will be 
analyzed at the Rutgers RWJMS at CentraState Family Medicine Residency Program 
office (597 Park Ave, Freehold, NJ 07728). CentraState Healthcare System and the 
Manor have provided an study site agreement indicating their support of this 
research. The Manor will not be engaged in research, and only Rutgers study staff 
members will engage in any research activities at this site.  
 

 
 
 
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3.0 Multi-Center Research 
N/A 
 
4.0 Subject Considerations 
 
4.1 Subject Selection and Enrollment Considerations  
 
A. Method to Identify Potential Subjects 
Research staff will identify patients who are currently admitted at the facility for subacute 
rehabilitation or long-term care that meet the age criteria of 50 years or older 
 
B. Recruitment Details 
Potential subjects will be verbally informed of the opportunity to participate in the study 
by co-investigators Dr Asselstine and Dr Shah at the Manor Health and Rehabilitation 
center, and if interested full details allowing for informed consent would be provided by 
the investigators. Subjects will be informed that their decision to participate or not 
participate in the study would have no influence on their care at the facility.  
C. Subject Screening 
The co-investigators will administer a simple screening survey to interested subjects 
which identifies basic demographics, such as age, gender, and hand dominance, history 
of upper extremity injuries within the past 1 year, open proximal upper extremity 
wounds, any allergies/hypersensitivities to the oils involved. The patient’s functional 
status for exercise based on the Duke Activity Status Index will also be assessed, and 
they must have a score equivalent to 3.5 or greater metabolic equivalents (METs). 
Potential subjects will sign a screening consent prior to partaking in this screening 
survey. 
§ Inclusion Criteria 
Subjects 50 years or older with no previous resistance training sessions in the past year 
and who are currently admitted at the Manor Health and Rehabilitation facility will be 
recruited.  
§ Exclusion Criteria 
Exclusion criteria included any history of musculoskeletal injury or weight bearing 
restrictions to the upper extremities within the past year. Participants cannot have any 
significant symptoms that would preclude them from exercising without medical 
clearance based on the American College of Sports Medicine’s “Recommendations for 
Preparticipation Health Screening,” [13] and those with an asymptomatic history of any 
cardiovascular, metabolic, or renal disease must have a functional capacity of at least 
>3.5 METs based on the Duke Activity Status Index to participate in the type of 
exercises that are part of this study, based on the American College of Sports 
Medicine’s “2011 Compendium of Physical Activities.” [20] Subjects with known adverse 

 
 
 
Protocol Title: Topical Eucalyptus globulus and Mentha x piperita on muscle soreness in older adults and the elderly 
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reaction or allergy to the essential oils or hypersensitivities to fragrances, any open 
upper extremity wounds or history of upper extremity skin grafts are excluded. 
 
4.2 Secondary Subjects 
None 
4.3 Number of Subjects 
 
A. Total Number of Subjects 
We anticipate enrolling 20 subjects to participate, 10 in the Mentha x piperita group and 
10 in the Eucalyptus globulus group.  
 
B. Total Number of Subjects If Multicenter Study 
N/A 
 
C. Feasibility 
It is feasible to enroll this number of subjects given there is a consistent population of 
residents within this facility that would meet the age criteria and, after discussion with 
physicians at this facility, would also meet the criteria for exercise clearance. The nature 
of the facility also allows for a continuous influx of patients to the subacute rehabilitation 
facility, which will allow for rolling enrollment into our study. 
4.4 Consent Procedures 
 
A. Consent Process 
§ Location of Consent Process 
The consent process will take place at the Manor Health and Rehabilitation 
facility.  
§ Ongoing Consent 
N/A 
§ Individual Roles for Researchers Involved in Consent 
Co-investigator Dr Sydney Asselstine will obtain consent from participants. 
The principal investigator, Dr Khan, will be available to answer any questions 
or concerns from potential subjects if needed.  
§ Consent Discussion Duration 
Ten minutes of time will be allotted to discuss informed consent. Should the 
subject require any clarification or a longer timeframe, accommodations will 
be made.  
§ Coercion or Undue Influence 
Subjects will be informed this is an optional study and their medical care at 
the facility will not be influenced by their decision to participate or not. 
Subjects will be able to voice any concerns or questions they may have. 
Subjects will be able to leave the study at any point should they choose.  

 
 
 
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§ Subject Understanding 
Subjects will be asked to repeat back what their role in the study would be. 
They will verbalize understanding prior to signing any consent forms.  
 
B. Waiver or Alteration of Consent Process  
N/A 
 
C. Documentation of Consent 
§ Documenting Consent 
All subjects will sign a form of informed consent. They will keep a copy and another 
copy will be stored in a secure file which only the research staff has access to.  
§ Waiver of Documentation Of Consent (i.e., will not obtain subject’s 
signature) 
N/A 
 
4.5 Special Consent/Populations 
 
A. Minors-Subjects Who Are Not Yet Adults  
N/A 
 
B. Wards of the State 
N/A 
 
C. Non-English-Speaking Subjects 
N/A 
 
D. Adults Unable to Consent / Decisionally Impaired Adults 
We will only be recruiting adults that have the decision-making capacity to consent.  
 
4.6 Economic Burden and/or Compensation for Subjects 
 
A. Expenses  
There will be no additional expense to the subjects participating in this research.  
B. Compensation/Incentives 
There will be no compensation or incentives for participating in this study.  
C. Compensation Documentation 
N/A 
  
4.7 Risks of Harm/Potential for Benefits to Subjects 
 
A. Description of Risks of Harm to Subjects 
§ Reasonably Foreseeable Risks of Harm 

 
 
 
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Topical application of the essential oils carries a risk of a local dermatitis reaction. [17] 
In a German multicenter study with over 6000 subjects with pre-existing dermatitis, only 
0.25% of subjects who received 2% topical Eucalyptus oil, and only 0.64% of subjects 
who received 2% Mentha x piperita oil experienced reactions. The maximum 
recommended dermal concentration for Eucalyptus is 20%, and for Mentha x piperita it 
is 5.4%, and so our study will utilize a concentration of 2%, well below those limits. 
[18,19] 
Participating subjects will be performing exercises during the study which may put them 
at risk for musculoskeletal injury. Muscle soreness is an expected result of the study. 
Subjects will be monitored closely during exercise by a physician to ensure proper 
technique is used. If subjects experience any discomfort beyond the expected level of 
soreness medical attention will be available and alternative methods of pain or 
inflammation control will be provided.  
§ Risk of Harm from an Intervention on a Subject with an Existing 
Condition 
If a subject has a known hypersensitivity or allergy to peppermint, eucalyptus, or the 
carrier oil they are at increased risk for adverse reactions from the intervention, 
particularly local dermatitis and thus will be excluded from the study. Anyone with open 
proximal upper extremity wounds or a history of skin graft to the upper extremity will 
also be excluded. Those with known upper extremity injuries in the past year or upper 
extremity weight bearing restrictions that may predispose them to musculoskeletal injury 
from exercise will be excluded from participation as well.  
 
§ Other Foreseeable Risks of Harm 
As with any research there is the risk of breach of confidentiality. All subject data will be 
stored in a secure file on a restricted drive that only investigators have access to. 
Subjects will be assigned a random identifier number. Names of subjects and their 
corresponding identifier number will be stored in one file, and a separate file will list the 
identifier number and the study data. Subject privacy will be ensured as well, as the 
exercise for this study will occur in a private room and only study staff will be aware of 
subject’s participation in the study. 
§ Observation and Sensitive Information 
N/A 
B. Procedures which Risk Harm to Embryo, Fetus, and/or Pregnant Subjects 
N/A 
C. Risks of Harm to Non-Subjects 
N/A 
D. Assessment of Social Behavior Considerations 
N/A 
E. Minimizing Risks of Harm 

 
 
 
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Subjects will have vital signs taken prior to initiating any form of exercise, and a 
physician will review them to ensure that the subject is medically optimized. All exercise 
will be closely observed by a physician to ensure proper form and minimize risk for 
injury, and nursing staff will be available for any assistance needed. If subjects feel in 
any way they are being harmed through these exercises they will be encouraged to 
cease participation in the study. Medical care will be available if any injuries do occur.  
Physicians will be directly observing subjects for 15 minutes after the first oil application 
to ensure there are no immediate adverse effects, and vital signs will be repeated at the 
end of this observation period. Subjects will have nurses available throughout the entire 
duration of the study. Subjects with known hypersensitivities or allergies to these 
substances, or pre-existing asthma, will be excluded from participating.  
Medications are available on-site that will be able to address any potential adverse 
effects. Topical creams or antihistamines will be available for any dermatitis, and should 
any severe systemic allergic reaction occur there are epinephrine injectable pens 
available as well. Nursing staff is present at the facility 24/7 to care for the subjects, and 
physicians are on-call as well. On-call physicians have the ability to promptly notify 
investigators of any concerns with study subjects.  
To reduce risk of breach of confidentiality, all subject data will be stored in a secure file 
on a restricted drive that only investigators have access to. Subjects will be assigned a 
random identifier number. Names of subjects and their corresponding identifier number 
will be stored in one file, and a separate file will list the identifier number and the study 
data. Subject privacy will be ensured as well, as the exercise for this study will occur in 
a private room and only study staff will be aware of subject’s participation in the study. 
§ Certificate of Confidentiality 
N/A 
§ Provisions to Protect the Privacy Interests of Subjects 
All aspects of this study involving the research subject will take place in an area with 
only the subject and the investigators present in order to protect their privacy. Any 
information that they feel uncomfortable disclosing will be omitted.  
 
 
F. Potential Benefits to Subjects 
Potential benefits to subjects include identifying a natural alternative for managing 
muscle soreness.  
5.0 Special Considerations 
 
5.1 Health Insurance Portability and Accountability Act (HIPAA) 
No identifiable health information will be utilized during this study.  
5.2 Family Educational Rights and Privacy Act (FERPA) 

 
 
 
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       N/A 
5.3 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
Review the following guidance to ensure you have sufficient information when 
specific populations are included in your research study. 
A. Special Populations 
      N/A 
5.4 General Data Protection Regulation (GDPR) 
N/A 
5.5 NJ Access to Medical Research Act (Surrogate Consent) 
N/A 
6.0 Data Management Plan 
 
6.1 Data Analysis 
Treatment analysis will involve a 1-way repeated measures ANOVA. Differences will be 
considered significant when p values are below an alpha level of 0.05.  
6.2 Data Security 
Subject data will be stored in a secure file on a restricted drive that only investigators 
have access to. Subjects will be assigned a random identifier number. Names of 
subjects and their corresponding identifier number will be stored in one file, and a 
separate file will list the identifier number and the corresponding study data.  
6.3 Data and Safety Monitoring 
A. Data/Safety Monitoring Plan 
Subject’s pain level following exercise will be monitored throughout the 72 hour data 
collection period and if the intervention does not seem to provide adequate relief of 
muscle soreness (to a functional level) alternative options will be offered to relieve 
discomfort.  
 
B. Data/Safety Monitoring Board Details 
N/A 
 
6.4 Reporting Results 
 
A. Individual Subjects’ Results  
Results will not be disclosed to individual subjects. 
B. Aggregate Results 
Aggregate research results will be available to subjects upon request.  
C. Professional Reporting 
We plan to publish any findings in a scientific peer-reviewed journal and/or present the 
data at a research conference to share with the scientific community.  

 
 
 
Protocol Title: Topical Eucalyptus globulus and Mentha x piperita on muscle soreness in older adults and the elderly 
Protocol Version Date: V3.03.20.21 
Page 14 of 16 
 
 
D. Clinical Trials Registration, Results Reporting and Consent Posting 
The investigation will be registered with Clinicaltrials.gov.  
6.5 Secondary Use of the Data    
N/A 
 
7.0 Research Repositories – Specimens and/or Data 
N/A 
8.0 Approvals/Authorizations 
 
Institutional Authorization Agreement has been obtained from CentraState Medical 
Center, which owns the Manor Health and Rehabilitation Center, for participation in 
research at this facility.   
9.0 Bibliography 
 
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of delayed-onset muscle soreness. Avicenna J Phytomed. 2017; 7(1):16-26. 
doi:10.22038/AJP.2016.6621  
2. Cheung, K., Hume, P., & Maxwell, L. Delayed Onset Muscle Soreness: 
Treatment Strategies and Performance Factors. Sports Medicine. 2003;33:145-
164. doi: 10.2165/00007256-200333020-00005  
3. Hanif, M., Nisar, S., Khan, G., Mushtaq, Z., Zubair, M. (2019) Essential Oils. 
Essential Oil Research. Springer, Cham. doi: 10.1007/978-3-030-16546-8_1  
4. Baser, K., and Buchbauer, G. (2009) Handbook of Essential Oils: Science, 
Technology, and Applications. CRC Press LLC.  
5. De Sousa, A., et. al. Antispasmodic effect of Mentha piperita essential oil on 
tracheal smooth muscle of rats. Journal of Ethnopharmacology. 2010: 
130(2);433-436. Doi: 10.1016/j.jep.2010.05.012 
6. Kehili, S. et. al. Peppermint (Mentha piperita L.) essential oil as a potent anti-
inflammatory, wound healing and anti-nociceptive drug. European Journal of 
Biological Research. 2020; 10(2):132-149. Doi: 10.5281/zenodo.3831042  
7. Vuong, Q. et al. Botanical, Phytochemical, and Anticancer Properties of the 
Eucalyptus Species. Chemistry & Biodiversity. 2015; 12: 907-924.  
8. Liapi, C. et al. Antinociceptive Properties of 1,8-Cineole and B-Pinene, from the 
Essential Oil of Eucalyptus camaldulensis Leaves, in Rodents. Planta Med.2007; 
73(12):1247-1254. Doi: 10.1055/s-2007-990224  
9. Mascolo, N. et al. Biological screening of Italian Medicinal Plants for anti-
inflammatory activity. Phytother Res. 1987; 1(1)28-31. Doi: 
10.1002/ptr.2650010107 
10. Jun, Y. et al. Effect of eucalyptus oil inhalation on pain and inflammatory 
responses after total knee replacement: a randomized clinical trial. Evid Based 
Complement Alternat Med. 2013;2103.502727. Doi: 10.1155/2013/502727. 

 
 
 
Protocol Title: Topical Eucalyptus globulus and Mentha x piperita on muscle soreness in older adults and the elderly 
Protocol Version Date: V3.03.20.21 
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11. Gobel, H. Effect of Peppermint and Eucalyptus Oil Preparations on 
Neurophysiological and Experimental Algesimetric Headache Parameters. 
Cephalalgia. 1994: 14; 228-234.  
12. Gobel, H. et al. Essential plant oils and headache mechanisms. Phytomed. 1995. 
2(2):93-102. Doi: 10.1016/S0944-7113(11)80053-X 
13. Liguori, G., Magal, M., & Riebe, D. (2018, February 18). ACSM's New Exercise 
Preparticipation Screening: Removing Barriers to Initiating Exercise. Retrieved 
January 18, 2021, from https://www.acsm.org/blog-detail/acsm-certified-
blog/2018/02/01/exercise-preparticipation-screening-removing-barriers-initiating-
exercise  
14. Weber, M., Servedio, F., Woodall, William. The Effects of Three Modalities on 
Delayed Onset Muscle Soreness. Journal of Orthopedic & Sports Physical 
Therapy. 1994; 20(5): 236-242. Doi: 10.2519/jospt.1994.20.5.236 
15. Zainuddin, Z et al. Effects of Massage on Delayed-Onset Muscle Soreness, 
Swelling, and Recovery of Muscle Function. J Athl Train. 2005; 40(3):174-180. 
16. Rey, E.  et al. The Effect of Recovery Strategies on Contractile Properties Using 
Tensiomyography and Perceived Muscle Soreness in Professional Soccer 
Players. Journal of Strength and Conditioning Research. 2012; 26(11);3081-
3088. DOI: 10.1519/JSC.0b013e3182470d33  
17. Tisserand, R., Young, R., & Williamson, E. M. (2014). The Skin. In Essential oil 
safety: A guide for health care professionals (pp. 69-98). Edinburgh: Churchill 
Livingstone/Elsevier. 
18. Tisserand, R., Young, R., & Williamson, E. M. (2014). Essential Oil Profiles: 
Eucalyptus globulus. In Essential oil safety: A guide for health care professionals   
Edinburgh: Churchill Livingstone/Elsevier.  
19. Tisserand, R., Young, R., & Williamson, E. M. (2014). Essential Oil Profiles: 
Mentha x piperita. In Essential oil safety: A guide for health care professionals 
(pp. 69-98). Edinburgh: Churchill Livingstone/Elsevier. (pp. 387-391) 
20. Ainsworth, et. A. 2011 Compendium of Physical Activities: A Second Update of 
Codes and MET Values. Medicine & Science in Sports & Exercise. 2011, 43(8); 
1575-1581. DOI: 10.1249/MSS.0b013e31821ece12