Clinical trial NCT01000142: Preventative Osteopathic Manipulative Treatment (OMT) and the Nursing Home Patient
Official title: Preventative OMT and the Nursing Home Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Health Status
Keywords: Osteopathic
Manipulation
Preventative
Elderly
Nursing Home
Prevention: General Health Status
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
First posted: 2009-10-22
Enrollment: 22
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in subject health status: reviewing data regarding medication usage, co-morbidities, hospitalizations and activities of daily living.
timeFrame: Five Months
Secondary outcomes:
Other outcomes:
Locations:
city: Kirksville
country: United States
facility: Kirksville Manor Care Center
state: Missouri
city: Kirksville
country: United States
facility: Twin Pines Adult Care Center
state: Missouri
Study officials:
affiliation: A.T. Still University-Kirksville College of Osteopathic Medicine
name: Karen T Snider, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Snider KT, Snider EJ, Johnson JC, Hagan C, Schoenwald C. Preventative osteopathic manipulative treatment and the elderly nursing home resident: a pilot study. J Am Osteopath Assoc. 2012 Aug;112(8):489-501.