NCT04866407

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 8, 2024

Completed
Last Updated

February 8, 2024

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

April 25, 2021

Results QC Date

June 16, 2023

Last Update Submit

June 16, 2023

Conditions

Keywords

Essential OilsMuscle SorenessMentha x piperitaEucalyptus globulus

Outcome Measures

Primary Outcomes (3)

  • Perceived Muscle Soreness

    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

    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

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

    72 hours after exercise

Study Arms (3)

Mentha x piperita

EXPERIMENTAL

A diluted solution of Mentha x piperita in carrier oil will be applied to the subject's interventional extremity.

Other: Mentha x piperita

Eucalyptus globulus

EXPERIMENTAL

A diluted solution of Eucalyptus globulus in carrier oil will be applied to the subject's interventional extremity.

Other: Eucalyptus globulus

No intervention

NO INTERVENTION

Each participant will have one extremity that receives no essential oil intervention.

Interventions

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.

Mentha x piperita

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.

Eucalyptus globulus

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Manor Health and Rehabillitation - CentraState

Freehold, New Jersey, 07728, United States

Location

Related Publications (19)

  • 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.

    PMID: 28265543BACKGROUND
  • 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.

    PMID: 12617692BACKGROUND
  • 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

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

    BACKGROUND
  • 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.

    PMID: 20488237BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 26080737BACKGROUND
  • 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.

    PMID: 17893834BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 23853660BACKGROUND
  • 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.

    PMID: 7954745BACKGROUND
  • 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.

    PMID: 23196150BACKGROUND
  • 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.

    PMID: 7827630BACKGROUND
  • 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.

    PMID: 16284637BACKGROUND
  • 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.

    PMID: 22210472BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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)

    BACKGROUND
  • Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR Jr, Tudor-Locke C, Greer JL, Vezina J, Whitt-Glover MC, Leon AS. 2011 Compendium of Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc. 2011 Aug;43(8):1575-81. doi: 10.1249/MSS.0b013e31821ece12.

    PMID: 21681120BACKGROUND

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Sydney Asselstine
Organization
Rutgers RWJMS

Study Officials

  • Zeeshan Khan, MD

    Rutgers RWJMS Department of Family Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

April 25, 2021

First Posted

April 29, 2021

Study Start

April 26, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

February 8, 2024

Results First Posted

February 8, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Do not plan to.

Locations