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

General Health Status Clinical Trial

Official title:

Preventative OMT and the Nursing Home Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000142
• Other study ID #: 501-332
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2018
• Source: A.T. Still University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• General Health Status

Intervention

Procedure:
• Osteopathic Manipulative Treatment
Focused osteopathic musculoskeletal exam; paraspinal muscle inhibition and/or soft tissue kneading or stretching; rib raising and or rib mobilization; abdominal diaphragm release technique; abdominal mesenteric/colon release; thoracic inlet release technique; hip flexion/extension range of motion; shoulder range of motion with pectoral traction; cervical paraspinal muscle inhibition and/or soft tissue kneading or stretching; suboccipital release technique; specific OMT of significant somatic dysfunction (variable).
• Light Touch
Focused osteopathic musculoskeletal exam; contact ribs to simulate rib raising and paraspinal muscle inhibition; contact lower rib margin to simulate abdominal diaphragm release; palpate the four quadrants of the abdomen to simulate abdominal mesenteric/colon release; contact shoulders to simulate thoracic inlet release; contact suboccipital region to simulate thoracic inlet release.

Locations

Country	Name	City	State
United States	Kirksville Manor Care Center	Kirksville	Missouri
United States	Twin Pines Adult Care Center	Kirksville	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
A.T. Still University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in subject health status: reviewing data regarding medication usage, co-morbidities, hospitalizations and activities of daily living.		Five Months