NCT01000142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

October 20, 2009

Last Update Submit

September 26, 2018

Conditions

General Health Status

Keywords

OsteopathicManipulationPreventativeElderlyNursing HomePrevention: General Health Status

Outcome Measures

Primary Outcomes (1)

  • Changes in subject health status: reviewing data regarding medication usage, co-morbidities, hospitalizations and activities of daily living.

    Five Months

Study Arms (3)

Treatment as Usual Control Group

NO INTERVENTION

Light Touch Group

SHAM COMPARATOR

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

Standard OMT Group

EXPERIMENTAL
Procedure: Osteopathic Manipulative Treatment

Interventions

Osteopathic Manipulative TreatmentPROCEDURE

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).

Also known as: OMT, OMM, Osteopathic Manipulative Medicine, Manipulation
Standard OMT Group
Light TouchPROCEDURE

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.

Also known as: Sham manipulation, Placebo manipulation
Light Touch Group

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kirksville Manor Care Center

Kirksville, Missouri, 63501, United States

Location

Twin Pines Adult Care Center

Kirksville, Missouri, 63501, United States

Location

Related Publications (1)

  • 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.

    PMID: 22904246DERIVED

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Karen T Snider, DO

    A.T. Still University-Kirksville College of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 22, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations

US(2)