Segmental and Somatic Dysfunction of Other Regions (M99.09)NCT04945798

Effects of Osteopathic Manipulative Treatment of Fascial Restrictions on Body Awareness, Mood, and Proprioception

A study testing OMT in people with Segmental and Somatic Dysfunction of Other Regions (M99.09), run by New York Institute of Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this research is to assess the effects osteopathic manipulative treatment (OMT) of fascial strain patterns on body awareness, proprioception, and mood. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Segmental and Somatic Dysfunction of Other Regions (M99.09)
What is being tested?: OMT
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 22 Mar 2021to 15 Mar 2022
Phase: Interventional
Are there results?: None posted in the registry

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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Functionally healthy adults that can move all four limbs within normal range of motion.

Who cannot join

People with the following conditions may not participate in the study: known bony injuries or fractures, open wounds, abscesses, infections of the soft tissue or bones, malignancies, auto-immune disorders affecting the musculoskeletal system (ex. lupus, rheumatoid arthritis), severe osteoporosis, aortic aneurysm, deep venous thrombosis, history of pulmonary embolism, bleeding disorders, neurovascular compromise, anticoagulation therapy, recent surgery, recent herniated discs, unstable heart conditions, and musculoskeletal strains or sprains, enlarged spleen or liver, mononucleosis, pregnancy, untreated hyperthyroidism.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York Institute of Technology College of Osteopathic Medicine at Arkansas State University
Jonesboro, Arkansas, 72467

Other trials in United States

About this study

The purpose of this research is to assess the effects osteopathic manipulative treatment (OMT) of fascial strain patterns on body awareness, proprioception, and mood.

Conditions: Segmental and Somatic Dysfunction of Other Regions (M99.09)
Being tested: OMT

What participants receive

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

OMTOther
OMT: direct myofascial release for the triplanar diagnonosis to the OA, thoracic outlet, respiratory diaphragm and pelvic diaphragm concluding with a pedal pump for 120 seconds

Study groups in NCT04945798
Study group	Role	What they receive
No OMT	No intervention	The STAI (Y2), DASS and Scale of Body Connection administered to this cohort at baseline (T1), after two treatments (T3), and after four treatments (T4).
OMT	Active comparator	OMT: direct myofascial release for the triplanar diagnonosis to the OA, thoracic outlet, respiratory diaphragm and pelvic diaphragm concluding with a pedal pump for 120 seconds. The STAI (Y2), DASS and Scale of Body Connection administered to this cohort at baseline (T1), after two treatments (T3), and after four treatments (T4). Receives: Other: OMT

What is being measured

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

Proprioception: Active Hip Flexion Position Detection.
Measurements use a goniometer. Measurements are in degrees. Participant judges accuracy of position on a scale of 1-5: 1= very inaccurate, 2= somewhat inaccurate, 3=neutral, 4= somewhat accurate, 5= very accurate.
Measured: 4 weeks
Proprioception: Active Shoulder Joint Position Detection.
Measurements use a goniometer. Measurements are in degrees. Participant judges accuracy of position on a scale of 1-5: 1= very inaccurate, 2= somewhat inaccurate, 3=neutral, 4= somewhat accurate, 5= very accurate.
Measured: 4 weeks
Proprioception: Active Thoracolumbar Position Detection.
Measurements use a goniometer. Measurements are in degrees. Participant judges accuracy of position on a scale of 1-5: 1= very inaccurate, 2= somewhat inaccurate, 3=neutral, 4= somewhat accurate, 5= very accurate.
Measured: 4 weeks
Body Awareness: Scale of Body Connection
A higher score represents better outcomes with increased body awareness. Minimum score: 0. Maximum for whole scale: 4. Scores are based on 12 items for body awareness (BA) and 8 items for body dissociation (BD). The items are scored on a 5-point scale, ranging from 0-4 with 0 at "not at all" and 4 at "all of the time." To score the BA subscale: sum the endorsed items and divide by the total number of items (12). To score the DB subscale: sum the endorsed items and divide by the total number of items (8). A positive change on the BA scale would represent an increase in bodily awareness, and a positive result. A negative change on the DB scale would represent a decrease in bodily dissociation, and a positive result.
Measured: 4 weeks
Mood: Depression Anxiety Stress Scale.
Increasing scores are associated with depression, anxiety, or stress. Items are scored within three subscales: depression, anxiety and stress. For individual subscales the scoring is as follows. Depression: normal (0-9), mild (10-13), moderate (14-20), severe (21-27), extremely severe (28+). Anxiety: normal (0-7), mild (8-9), moderate (10-14), severe (15-19), extremely severe (20+). Stress: normal (0-14), mild (15-18), moderate (19-25), severe (26-33), extremely severe (34+). Minimum score is 0 and maximum score is 126 for the entire scale.
Measured: 4 weeks
Mood: State Trait Anxiety Inventory Form Y-2.
A higher score is associated with increased anxiety trait. The minimum score is 20. The maximum score is 80. The range for no or little anxiety is 20-37. Moderate anxiety scores are from 38-44. High anxiety range is from 45-80.
Measured: 4 weeks

Timeline

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

22 Mar 202115 Mar 2022

First posted30 Jun 2021
Study start22 Mar 2021
Primary completion15 Mar 2022
Study completion15 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Segmental and Somatic Dysfunction of Other Regions (M99.09)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04945798
Sponsor's protocol ID: BHS1611
Status last verified: Apr 2022
First submitted: 10 Mar 2021
Last updated: 29 Apr 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Trevithick A, Park SY. A Novel Method for Assessment of Proprioception. Journal of Emerging Investigators. 2018. https://www.emerginginvestigators.org/articles/a-novel-method-for-assessment-of-proprioception/pdf. Published June 22, 2018. Accessed January 7, 2021.
Price CJ, Thompson EA. Measuring dimensions of body connection: body awareness and bodily dissociation. J Altern Complement Med. 2007 Nov;13(9):945-53. doi: 10.1089/acm.2007.0537.
PubMed 18047441
Kosmahl EM. Goniometry: Thoraco-Lumbar Spine Sidebending. The University of Scranton. https://www.scranton.edu/faculty/kosmahl/courses/gonio/spine/pages/thor-side.shtml. Accessed February 1, 2021.
Seffinger MA, executive ed. Foundations of Osteopathic Medicine: Philosophy, Science, Clinical Applications, and Research. 4th ed. Philadelphia, PA: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2018.
Chila AG, executive ed. Foundations of Osteopathic Medicine. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011.
Beatty DR. The Pocket Manual of OMT. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins/Wolters Kluwer Health, Inc.; 2011.
Lovibond, S.H. & Lovibond, P.F. Manual for the Depression Anxiety Stress Scales. 2nd edition. 1995. Sydney: Psychology Foundation. http://www2.psy.unsw.edu.au/dass/Download%20files/Dass42.pdf. Updated July 26, 2018. Accessed January 23, 2021.
Measurement of Range of Motion of the Hip. Musculoskeletal Key. https://musculoskeletalkey.com/measurement-of-range-of-motion-of-the-hip/. Published August 10, 2016. Accessed February 1, 2021.
Nicholas AS; Nicholas EA. In: Atlas of Osteopathic Techniques. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2016.
Speilberger CD. State Trait Anxiety Inventory for Adults. Mind Garden, Inc. www.mindgarden.com. 1977. Accessed December 31, 2020.
van der Wal J. The architecture of the connective tissue in the musculoskeletal system-an often overlooked functional parameter as to proprioception in the locomotor apparatus. Int J Ther Massage Bodywork. 2009 Dec 7;2(4):9-23. doi: 10.3822/ijtmb.v2i4.62.
PubMed 21589740
Levy EC, Jung MK. Effects of a myofascial and lymphatic osteopathic manipulative treatment protocol on mood and body connection: a randomized pilot study. J Osteopath Med. 2025 Jul 21;126(1):37-46. doi: 10.1515/jom-2024-0196. eCollection 2026 Jan 1.
PubMed 40678989

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Osteopathic Manipulative Treatment of Fascial Restrictions on Body Awareness, Mood, and Proprioception
ClinicalTrials.gov ID: NCT04945798
Acronym / sponsor ID: BHS1611
Conditions: Segmental and Somatic Dysfunction of Other Regions (M99.09)
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: New York Institute of TechnologyUniversity, hospital or other
Study start: 22 Mar 2021 (actual)
Primary completion: 15 Mar 2022 (actual)
Study completion: 15 Mar 2022 (actual)
First posted: 30 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this research is to assess the effects osteopathic manipulative treatment (OMT) of fascial strain patterns on body awareness, proprioception, and mood.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
No OMT	No intervention	–The STAI (Y2), DASS and Scale of Body Connection administered to this cohort at baseline (T1), after two treatments (T3), and after four treatments (T4).
OMT	Active comparator	Other: OMTOMT: direct myofascial release for the triplanar diagnonosis to the OA, thoracic outlet, respiratory diaphragm and pelvic diaphragm concluding with a pedal pump for 120 seconds. The STAI (Y2), DASS and Scale of Body Connection administered to this cohort at baseline (T1), after two treatments (T3), and after four treatments (T4).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Functionally healthy adults that can move all four limbs within normal range of motion.

Key exclusion criteria (1 listed)

People with the following conditions may not participate in the study: known bony injuries or fractures, open wounds, abscesses, infections of the soft tissue or bones, malignancies, auto-immune disorders affecting the musculoskeletal system (ex. lupus, rheumatoid arthritis), severe osteoporosis, aortic aneurysm, deep venous thrombosis, history of pulmonary embolism, bleeding disorders, neurovascular compromise, anticoagulation therapy, recent surgery, recent herniated discs, unstable heart conditions, and musculoskeletal strains or sprains, enlarged spleen or liver, mononucleosis, pregnancy, untreated hyperthyroidism.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OMTOMT: direct myofascial release for the triplanar diagnonosis to the OA, thoracic outlet, respiratory diaphragm and pelvic diaphragm concluding with a pedal pump for 120 seconds	Other	OMT

Primary outcome

Proprioception: Active Hip Flexion Position Detection.
Time frame: 4 weeks
Measurements use a goniometer. Measurements are in degrees. Participant judges accuracy of position on a scale of 1-5: 1= very inaccurate, 2= somewhat inaccurate, 3=neutral, 4= somewhat accurate, 5= very accurate.
Proprioception: Active Shoulder Joint Position Detection.
Time frame: 4 weeks
Measurements use a goniometer. Measurements are in degrees. Participant judges accuracy of position on a scale of 1-5: 1= very inaccurate, 2= somewhat inaccurate, 3=neutral, 4= somewhat accurate, 5= very accurate.
Proprioception: Active Thoracolumbar Position Detection.
Time frame: 4 weeks
Measurements use a goniometer. Measurements are in degrees. Participant judges accuracy of position on a scale of 1-5: 1= very inaccurate, 2= somewhat inaccurate, 3=neutral, 4= somewhat accurate, 5= very accurate.
Body Awareness: Scale of Body Connection
Time frame: 4 weeks
A higher score represents better outcomes with increased body awareness. Minimum score: 0. Maximum for whole scale: 4. Scores are based on 12 items for body awareness (BA) and 8 items for body dissociation (BD). The items are scored on a 5-point scale, ranging from 0-4 with 0 at "not at all" and 4 at "all of the time." To score the BA subscale: sum the endorsed items and divide by the total number of items (12). To score the DB subscale: sum the endorsed items and divide by the total number of items (8). A positive change on the BA scale would represent an increase in bodily awareness, and a positive result. A negative change on the DB scale would represent a decrease in bodily dissociation, and a positive result.
Mood: Depression Anxiety Stress Scale.
Time frame: 4 weeks
Increasing scores are associated with depression, anxiety, or stress. Items are scored within three subscales: depression, anxiety and stress. For individual subscales the scoring is as follows. Depression: normal (0-9), mild (10-13), moderate (14-20), severe (21-27), extremely severe (28+). Anxiety: normal (0-7), mild (8-9), moderate (10-14), severe (15-19), extremely severe (20+). Stress: normal (0-14), mild (15-18), moderate (19-25), severe (26-33), extremely severe (34+). Minimum score is 0 and maximum score is 126 for the entire scale.
Mood: State Trait Anxiety Inventory Form Y-2.
Time frame: 4 weeks
A higher score is associated with increased anxiety trait. The minimum score is 20. The maximum score is 80. The range for no or little anxiety is 20-37. Moderate anxiety scores are from 38-44. High anxiety range is from 45-80.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
BackgroundTrevithick A, Park SY. A Novel Method for Assessment of Proprioception. Journal of Emerging Investigators. 2018. https://www.emerginginvestigators.org/articles/a-novel-method-for-assessment-of-proprioception/pdf. Published June 22, 2018. Accessed January 7, 2021.
Background: PubMed 18047441Price CJ, Thompson EA. Measuring dimensions of body connection: body awareness and bodily dissociation. J Altern Complement Med. 2007 Nov;13(9):945-53. doi: 10.1089/acm.2007.0537.
BackgroundKosmahl EM. Goniometry: Thoraco-Lumbar Spine Sidebending. The University of Scranton. https://www.scranton.edu/faculty/kosmahl/courses/gonio/spine/pages/thor-side.shtml. Accessed February 1, 2021.
BackgroundSeffinger MA, executive ed. Foundations of Osteopathic Medicine: Philosophy, Science, Clinical Applications, and Research. 4th ed. Philadelphia, PA: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2018.
BackgroundChila AG, executive ed. Foundations of Osteopathic Medicine. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011.
BackgroundBeatty DR. The Pocket Manual of OMT. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins/Wolters Kluwer Health, Inc.; 2011.
BackgroundLovibond, S.H. & Lovibond, P.F. Manual for the Depression Anxiety Stress Scales. 2nd edition. 1995. Sydney: Psychology Foundation. http://www2.psy.unsw.edu.au/dass/Download%20files/Dass42.pdf. Updated July 26, 2018. Accessed January 23, 2021.
BackgroundMeasurement of Range of Motion of the Hip. Musculoskeletal Key. https://musculoskeletalkey.com/measurement-of-range-of-motion-of-the-hip/. Published August 10, 2016. Accessed February 1, 2021.
BackgroundNicholas AS; Nicholas EA. In: Atlas of Osteopathic Techniques. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2016.
BackgroundSpeilberger CD. State Trait Anxiety Inventory for Adults. Mind Garden, Inc. www.mindgarden.com. 1977. Accessed December 31, 2020.
Background: PubMed 21589740van der Wal J. The architecture of the connective tissue in the musculoskeletal system-an often overlooked functional parameter as to proprioception in the locomotor apparatus. Int J Ther Massage Bodywork. 2009 Dec 7;2(4):9-23. doi: 10.3822/ijtmb.v2i4.62.
Derived from this study: PubMed 40678989Levy EC, Jung MK. Effects of a myofascial and lymphatic osteopathic manipulative treatment protocol on mood and body connection: a randomized pilot study. J Osteopath Med. 2025 Jul 21;126(1):37-46. doi: 10.1515/jom-2024-0196. eCollection 2026 Jan 1.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Suessle, DO principal investigator

New York Institute of Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing OMT in people with Segmental and Somatic Dysfunction of Other Regions (M99.09), run by New York Institute of Technology 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Apr 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proprioception: Active Hip Flexion Position Detection. (time frame: 4 weeks). The study lists 6 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 NCT04945798, which also lists 12 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 29 Apr 2022.