Topical Eucalyptus Globulus and Mentha x Piperita on Muscle Soreness in Older Adults and the Elderly

June 16, 2023 updated by: Sydney Asselstine, MD, Rutgers, The State University of New Jersey

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

Subjects over age 50 with no previous resistance training sessions will be recruited at a subacute rehabilitation and long term care facility.

Subjects will be asked to perform a series of eccentric upper arm curl exercises under physician supervision in order to induce muscle soreness. Afterwards, topical oil containing a 2% dilution of either eucalyptus or peppermint oil in fractionated coconut oil will be applied to the flexor surface of the proximal non-dominent arm, and plain fractionated coconut oil to the other arm. This will be repeated at 8 hours and 24 hours after exercise. Subjects will be asked to report their perceived level of muscle soreness using a visual analog scale survey 24, 48, and 72 hours after exercise.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Subjects 50 years old and above with no previous resistance training sessions within the past year will be recruited at a subacute rehabilitation and long-term care facility. A verbal explanation will be provided to the potential subjects by investigators 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) and medical history, 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 3.5METs or greater based on the Duke Activity Status Index. 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.

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. 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).

Participants will be divided randomly 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. 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 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. These outcomes will be recorded by investigators for both the intervention and control upper extremity at 24, 48, and 72 hours post-exercise.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • The Manor Health and Rehabillitation - CentraState

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subjects 50 years or older with no previous resistance training sessions in the past year
  • Duke Activity Screening Index functional capacity of at least 3.5 metabolic equivalents or greater
  • currently admitted at the Manor Health and Rehabilitation

Exclusion Criteria:

  • history of musculoskeletal injury or weight bearing restrictions to the upper extremities within the past year
  • known adverse reaction or allergy to the essential oils or hypersensitivities to fragrances
  • open upper extremity wounds or history of upper extremity skin grafts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mentha x piperita
A diluted solution of Mentha x piperita in carrier oil will be applied to the subject's interventional extremity.
Other: Mentha x piperita
2% solution of Mentha x piperita diluted in fractionated coconut oil for topical application will be applied to one extremity of the subjects in the 'Mentha x piperita' group.
Experimental: Eucalyptus globulus
A diluted solution of Eucalyptus globulus in carrier oil will be applied to the subject's interventional extremity.
Other: Eucalyptus globulus
2% solution of Eucalyptus globulus diluted in fractionated coconut oil for topical application will be applied to one extremity of the subjects in the 'Eucalyptus globulus' group.
No Intervention: No intervention
Each participant will have one extremity that receives no essential oil intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Muscle Soreness
Time Frame: 24 hours after exercise
Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness
24 hours after exercise
Perceived Muscle Soreness
Time Frame: 48 hours after exercise
Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness
48 hours after exercise
Perceived Muscle Soreness
Time Frame: 72 hours after exercise
Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness
72 hours after exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Zeeshan Khan, MD, Rutgers RWJMS Department of Family Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

April 25, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2021000112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Do not plan to.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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