Completed

NCT Number: NCT04945798

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Jonesboro, Arkansas, 72467, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

New York Institute of Technology

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 30, 2021
Registry last updated: Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.