CClinicalTrials.gg
CompletedNCT06125574Updated Nov 14, 2023

Investigating the Effects of Osteopathic Manipulative Treatment on Stress Management in Medical Students

An interventional study of Osteopathic Manipulative Medicine in Stress, Job, Student Burnout and Stress, Physiological, sponsored by The Touro College and University System. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-14.

Sponsored by The Touro College and University System · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2023, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate stress biomarkers, subjective stress levels, and cognitive function in medical students. The main question[s] it aims to answer are:

Does regular osteopathic manipulative treatment affect stress in medical students? Does regular osteopathic manipulative treatment affect cognitive function in medical students?

Participants will be split into two groups, control and treatment, and undergo a designated protocol for six weeks. The treatment protocol will include weekly sessions of three OMT techniques: paraspinal inhibition, rib raising, and condylar decompression. Concurrently, participants' salivary cortisol levels will be collected weekly and analyzed using an Invitrogen ELISA Immunoassay Kit. Additionally, cognitive function will be assessed weekly via Lumosity, while stress levels are gauged using the College Student Stress Scale (CSSS) survey.

Researchers will compare one cohort of medical students who receive weekly OMT and another cohort of medical students who have weekly check-ins without OMT to see if OMT can affect changes in stress biomarkers, subjective stress scales, and cognitive function.

02

Conditions studied

  • Stress, Job
  • Student Burnout
  • Stress, Physiological
  • Stress, Psychological

Keywords

  • Osteopathic Manipulative Medicine
  • Osteopathic Manipulative Treatment
  • OMM
  • OMT
  • Cortisol
  • Medical Student Stress
  • Cognitive Function
03

In context

Occupational Stress

236 studies on the registry are indexed under Occupational Stress; 64 are open to participants now.

This study's enrollment of 10 is below the median of 89 across 167 interventional studies indexed under Occupational Stress.

Browse Occupational Stress studies →

Lead sponsor

The Touro College and University System is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • First-year medical students
  • Not currently receiving osteopathic manipulative treatment (OMT)

Exclusion criteria

Exclusion Criteria:

  • Pregnant
  • History of spinal surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Treatment

    Other: Osteopathic Manipulative Medicine

  • No intervention
    Control

Interventions

  • OtherOsteopathic Manipulative Medicine

    Individuals in the experimental cohort will undergo a systematic osteopathic manipulative treatment protocol encompassing paraspinal inhibition, rib raising, and condylar decompression techniques.

06

What researchers measure

Primary outcomes

  1. Weekly Cortisol Level

    Salivary Cortisol as measured in an ELISA Immunoassay

    Time frame: Weekly, over the course of 8 week study

  2. College Student Subjective Stress Survey (CSSS) Numerical Score

    Numerical Score collected from the College Student Subjective Stress Survey, a 10-item survey investigating occurrence of stressors over the course of a week, with each item being rated from 1 (Never) to 5 (Very Often). A lower score reflects lower perceived stress while a higher score reflects higher perceived stress.

    Time frame: Weekly, over the course of 8 week study

  3. LPI

    Learning Performance Index Metric from Lumosity

    Time frame: Weekly, over the course of 8 week study

07

Study locations

1 site
  • Touro College of Osteopathic Medicine - Harlem
    New York, New York 10027, United States
08

References and documents

Publications

  • Bath M, Owens J. Physiology, Viscerosomatic Reflexes. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559218/ PubMed 32644644 ↗
  • Degenhardt BF, Darmani NA, Johnson JC, Towns LC, Rhodes DC, Trinh C, McClanahan B, DiMarzo V. Role of osteopathic manipulative treatment in altering pain biomarkers: a pilot study. J Am Osteopath Assoc. 2007 Sep;107(9):387-400. PubMed 17908831 ↗
  • Feldt RC. Development of a brief measure of college stress: the college student stress scale. Psychol Rep. 2008 Jun;102(3):855-60. doi: 10.2466/pr0.102.3.855-860. PubMed 18763455 ↗
  • Licciardone JC, Kearns CM, Hodge LM, Bergamini MV. Associations of cytokine concentrations with key osteopathic lesions and clinical outcomes in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Sep;112(9):596-605. doi: 10.7556/jaoa.2012.112.9.596. Erratum In: J Am Osteopath Assoc. 2017 Jun 1;117(6):350. doi: 10.7556/jaoa.2017.070. PubMed 22984233 ↗
  • Licciardone JC, Schultz MJ, Amen B. Osteopathic Manipulation in the Management of Chronic Pain: Current Perspectives. J Pain Res. 2020 Jul 20;13:1839-1847. doi: 10.2147/JPR.S183170. eCollection 2020. PubMed 32765058 ↗
  • Lee BK, Glass TA, McAtee MJ, Wand GS, Bandeen-Roche K, Bolla KI, Schwartz BS. Associations of salivary cortisol with cognitive function in the Baltimore memory study. Arch Gen Psychiatry. 2007 Jul;64(7):810-8. doi: 10.1001/archpsyc.64.7.810. PubMed 17606815 ↗
  • Saeed SMU, Anwar SM, Khalid H, Majid M, Bagci AU. EEG based Classification of Long-term Stress Using Psychological Labeling. Sensors (Basel). 2020 Mar 29;20(7):1886. doi: 10.3390/s20071886. PubMed 32235295 ↗
  • Schoorlemmer RM, Peeters GM, van Schoor NM, Lips P. Relationships between cortisol level, mortality and chronic diseases in older persons. Clin Endocrinol (Oxf). 2009 Dec;71(6):779-86. doi: 10.1111/j.1365-2265.2009.03552.x. Epub 2009 Feb 18. PubMed 19226268 ↗
  • Shute, V. J., Ventura, M., & Ke, F. (2015). The power of play: The effects of portal 2 and lumosity on cognitive and noncognitive skills. Computers & Education, 80, 58-67.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06125574
Lead sponsor
The Touro College and University System
Responsible party
Mikhail Volokitin, MD, DO. (Assistant Professor, The Touro College and University System) — Principal investigator
First posted
Nov 9, 2023
Start date
Jun 15, 2023
Primary completion
Sep 15, 2023
Completion
Sep 30, 2023
Last update
Nov 14, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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