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

This study has been completed.
Sponsor:
Information provided by:
A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01000142
First received: October 20, 2009
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
General Health Status
Procedure: Osteopathic Manipulative Treatment
Procedure: Light Touch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Preventative OMT and the Nursing Home Patient

Resource links provided by NLM:


Further study details as provided by A.T. Still University of Health Sciences:

Primary Outcome Measures:
  • Changes in subject health status: reviewing data regarding medication usage, co-morbidities, hospitalizations and activities of daily living. [ Time Frame: Five Months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: October 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment as Usual Control Group
Sham Comparator: Light Touch Group
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.
Procedure: 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.
Other Names:
  • Sham manipulation
  • Placebo manipulation
Experimental: Standard OMT Group 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).
Other Names:
  • OMT
  • OMM
  • Osteopathic Manipulative Medicine
  • Manipulation

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000142

Locations
United States, Missouri
Twin Pines Adult Care Center
Kirksville, Missouri, United States, 63501
Kirksville Manor Care Center
Kirksville, Missouri, United States, 63501
Sponsors and Collaborators
A.T. Still University of Health Sciences
Investigators
Principal Investigator: Karen T Snider, DO A.T. Still University-Kirksville College of Osteopathic Medicine
  More Information

No publications provided by A.T. Still University of Health Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen T. Snider, D.O., Principal Investigator, A.T. Still University
ClinicalTrials.gov Identifier: NCT01000142     History of Changes
Other Study ID Numbers: 501-332
Study First Received: October 20, 2009
Last Updated: July 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by A.T. Still University of Health Sciences:
Osteopathic
Manipulation
Preventative
Elderly
Nursing Home
Prevention: General Health Status

ClinicalTrials.gov processed this record on August 28, 2014