AzTrials
AzTrials

Muscle SorenessNCT04866407

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

A study testing Mentha x piperita and Eucalyptus globulus in people with Muscle Soreness, run by Rutgers, The State University of New Jersey at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Muscle Soreness
What is being tested?
Mentha x piperita and Eucalyptus globulus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
26 Apr 2021to 30 Jun 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Manor Health and Rehabillitation - CentraState

    Freehold, New Jersey, 07728

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Muscle Soreness
Being tested
Mentha x piperita, Eucalyptus globulus
Keywords
Essential Oils, Muscle Soreness, Mentha x piperita, Eucalyptus globulus
Medical subject headings
Myalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mentha x piperitaOther

    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.

  • Eucalyptus globulusOther

    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.

Study groups in NCT04866407
Study groupRoleWhat they receive
Mentha x piperitaExperimentalA diluted solution of Mentha x piperita in carrier oil will be applied to the subject's interventional extremity.
Receives: Other: Mentha x piperita
Eucalyptus globulusExperimentalA diluted solution of Eucalyptus globulus in carrier oil will be applied to the subject's interventional extremity.
Receives: Other: Eucalyptus globulus
No interventionNo interventionEach participant will have one extremity that receives no essential oil intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Muscle Soreness

    Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness

    Measured: 24 hours after exercise

  2. Perceived Muscle Soreness

    Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness

    Measured: 48 hours after exercise

  3. Perceived Muscle Soreness

    Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness

    Measured: 72 hours after exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2021
  2. Study start26 Apr 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Why it stopped: Difficulty recruiting

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04866407
Sponsor's protocol ID
Pro2021000112
Status last verified
Jun 2023
First submitted
25 Apr 2021
Last updated
8 Feb 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Do not plan to.

Publications

  • Meamarbashi A. Herbs and natural supplements in the prevention and treatment of delayed-onset muscle soreness. Avicenna J Phytomed. 2017 Jan-Feb;7(1):16-26.

    PubMed 28265543
  • Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.

    PubMed 12617692
  • 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

  • Baser, K., and Buchbauer, G. (2009) Handbook of Essential Oils: Science, Technology, and Applications. CRC Press LLC.

  • de Sousa AA, Soares PM, de Almeida AN, Maia AR, de Souza EP, Assreuy AM. Antispasmodic effect of Mentha piperita essential oil on tracheal smooth muscle of rats. J Ethnopharmacol. 2010 Jul 20;130(2):433-6. doi: 10.1016/j.jep.2010.05.012. Epub 2010 May 19.

    PubMed 20488237
  • 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

  • Vuong QV, Chalmers AC, Jyoti Bhuyan D, Bowyer MC, Scarlett CJ. Botanical, Phytochemical, and Anticancer Properties of the Eucalyptus Species. Chem Biodivers. 2015 Jun;12(6):907-24. doi: 10.1002/cbdv.201400327.

    PubMed 26080737
  • Liapi C, Anifandis G, Chinou I, Kourounakis AP, Theodosopoulos S, Galanopoulou P. Antinociceptive properties of 1,8-Cineole and beta-pinene, from the essential oil of Eucalyptus camaldulensis leaves, in rodents. Planta Med. 2007 Oct;73(12):1247-54. doi: 10.1055/s-2007-990224. Epub 2007 Sep 24.

    PubMed 17893834
  • 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

  • Jun YS, Kang P, Min SS, Lee JM, Kim HK, Seol GH. Effect of eucalyptus oil inhalation on pain and inflammatory responses after total knee replacement: a randomized clinical trial. Evid Based Complement Alternat Med. 2013;2013:502727. doi: 10.1155/2013/502727. Epub 2013 Jun 18.

    PubMed 23853660
  • Gobel H, Schmidt G, Soyka D. Effect of peppermint and eucalyptus oil preparations on neurophysiological and experimental algesimetric headache parameters. Cephalalgia. 1994 Jun;14(3):228-34; discussion 182. doi: 10.1046/j.1468-2982.1994.014003228.x.

    PubMed 7954745
  • Gobel H, Schmidt G, Dworschak M, Stolze H, Heuss D. Essential plant oils and headache mechanisms. Phytomedicine. 1995 Oct;2(2):93-102. doi: 10.1016/S0944-7113(11)80053-X.

    PubMed 23196150
  • Weber MD, Servedio FJ, Woodall WR. The effects of three modalities on delayed onset muscle soreness. J Orthop Sports Phys Ther. 1994 Nov;20(5):236-42. doi: 10.2519/jospt.1994.20.5.236.

    PubMed 7827630
  • Zainuddin Z, Newton M, Sacco P, Nosaka K. Effects of massage on delayed-onset muscle soreness, swelling, and recovery of muscle function. J Athl Train. 2005 Jul-Sep;40(3):174-80.

    PubMed 16284637
  • Rey E, Lago-Penas C, Lago-Ballesteros J, Casais L. The effect of recovery strategies on contractile properties using tensiomyography and perceived muscle soreness in professional soccer players. J Strength Cond Res. 2012 Nov;26(11):3081-8. doi: 10.1519/JSC.0b013e3182470d33.

    PubMed 22210472

Questions about this trial

What is this clinical trial studying?

A study testing Mentha x piperita and Eucalyptus globulus in people with Muscle Soreness, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Muscle Soreness (time frame: 24 hours after exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04866407, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in