Preventative Osteopathic Manipulative Treatment (OMT) and the Nursing Home Patient

Not Applicable

Completed

• Conditions: General Health Status

• Registration Number: NCT01000142
• Lead Sponsor: A.T. Still University of Health Sciences

Brief Summary

This pilot research study will investigate the possible benefit that elderly nursing home patients may receive from regular Osteopathic Manipulative Medicine (OMM) care during the winter months. The study is based on the osteopathic philosophies that structure and function are interrelated and that the body has self-healing mechanisms. The body is expected to have optimized ability to heal itself "when all its parts are in place" (AT Still). This study is looking at subject population for whom their ability to take care of themselves is diminished by their underlying diseases. Based on the osteopathic philosophies, optimization of the nursing home patient's physical structure through osteopathic manipulative treatment (OMT) should enhance their body's homeostatic mechanisms. This study is assessing the validity of these philosophies by looking at the effect of OMT on the global health of these individuals.

Detailed Description

This study will randomly assign 36 nursing home patients from two Kirksville nursing homes into three groups of twelve subjects: 1) treatment as usual (TAU) control group; 2) light touch (LT) group, and 3) standard OMT group.

This study will begin with rolling admission of volunteer nursing home patients starting in October 2009. Subjects in the LT and OMT group would receive focused musculoskeletal evaluations twice a month for 5 months (10 visits). The OMT group would also receive an OMT protocol each visit that would specifically address optimization of homeostatic mechanisms - balancing autonomic nervous system and improving lymphatic drainage- along with OMT that would specifically target somatic dysfunction found on that day's evaluation. The LT group subjects would receive a light touch protocol meant to simulate OMT. The TAU group will receive no intervention. The protocol period will end for all subjects by March 2010. All osteopathic examinations, assessments, and treatments will be performed at the participating nursing homes.

Throughout the protocol period, at the end of the winter (March 2010), and three months later (June 2010), retrospective chart reviews will be conducted on all subjects. All cause morbidity and mortality for all subjects will be assessed by monitoring their medications, health history changes, and hospitalizations.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-21
• Study First Posted: 2009-10-22
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Resident of Participating Nursing Home
• Life Expectancy of at Least 6 Months

Exclusion Criteria

• Diagnosis of Terminal Cancer
• Diagnosis of Active Tuberculosis
• Diagnosis of Metabolic Bone Disease or Condition That Would Place Patient at Risk for Pathological Fracture
• Unable to Cooperate
• Unable to Tolerate OMT
• OMT is Contraindicated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in subject health status: reviewing data regarding medication usage, co-morbidities, hospitalizations and activities of daily living.	Five Months

Trial Locations

Locations (2)

Kirksville Manor Care Center; 🇺🇸 Kirksville, Missouri, United States

Twin Pines Adult Care Center; 🇺🇸 Kirksville, Missouri, United States