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

NCT04945798 | Completed

• 1 other identifier: BHS1611
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  4 weeks

Study Arms (2)

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).

Other: OMT

Interventions

OMT OTHER

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

OMT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

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

Jonesboro, Arkansas, 72467, United States

Location

Related Publications (11)

• 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.

  BACKGROUND

• 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.

  PMID: 18047441 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Chila AG, executive ed. Foundations of Osteopathic Medicine. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011.

  BACKGROUND

• Beatty DR. The Pocket Manual of OMT. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins/Wolters Kluwer Health, Inc.; 2011.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Nicholas AS; Nicholas EA. In: Atlas of Osteopathic Techniques. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2016.

  BACKGROUND

• Speilberger CD. State Trait Anxiety Inventory for Adults. Mind Garden, Inc. www.mindgarden.com. 1977. Accessed December 31, 2020.

  BACKGROUND

• 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.

  PMID: 21589740 BACKGROUND

Study Officials

• Amy Suessle, DO

  New York Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: June 30, 2021
• Study Start: March 22, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)