- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04945798
Effects of Osteopathic Manipulative Treatment of Fascial Restrictions on Body Awareness, Mood, and Proprioception
22. april 2022 opdateret af: New York Institute of Technology
The purpose of this research is to assess the effects osteopathic manipulative treatment (OMT) of fascial strain patterns on body awareness, proprioception, and mood.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
29
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arkansas
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Jonesboro, Arkansas, Forenede Stater, 72467
- New York Institute of Technology College of Osteopathic Medicine at Arkansas State University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: No OMT
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).
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Aktiv komparator: OMT
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). |
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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Proprioception: Active Hip Flexion Position Detection.
Tidsramme: 4 weeks
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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.
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4 weeks
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Proprioception: Active Shoulder Joint Position Detection.
Tidsramme: 4 weeks
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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.
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4 weeks
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Proprioception: Active Thoracolumbar Position Detection.
Tidsramme: 4 weeks
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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.
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4 weeks
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Body Awareness: Scale of Body Connection
Tidsramme: 4 weeks
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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.
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4 weeks
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Mood: Depression Anxiety Stress Scale.
Tidsramme: 4 weeks
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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.
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4 weeks
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Mood: State Trait Anxiety Inventory Form Y-2.
Tidsramme: 4 weeks
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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.
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4 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Amy Suessle, DO, New York Institute of Technology
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
22. marts 2021
Primær færdiggørelse (Faktiske)
15. marts 2022
Studieafslutning (Faktiske)
15. marts 2022
Datoer for studieregistrering
Først indsendt
10. marts 2021
Først indsendt, der opfyldte QC-kriterier
22. juni 2021
Først opslået (Faktiske)
30. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- BHS1611
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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