General Health StatusNCT01000142
Preventative Osteopathic Manipulative Treatment (OMT) and the Nursing Home Patient
A study testing Osteopathic Manipulative Treatment and Light Touch in people with General Health Status, run by A.T. Still University of Health Sciences at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- General Health Status
- What is being tested?
- Osteopathic Manipulative Treatment and Light Touch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Resident of Participating Nursing Home
- Life Expectancy of at Least 6 Months
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kirksville Manor Care Center
Kirksville, Missouri, 63501
Twin Pines Adult Care Center
Kirksville, Missouri, 63501
About this study
Official title: Preventative OMT and the Nursing Home Patient
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.
Read the 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.
- Conditions
- General Health Status
- Being tested
- Osteopathic Manipulative Treatment, Light Touch
- Keywords
- Osteopathic, Manipulation, Preventative, Elderly, Nursing Home, Prevention: General Health Status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentProcedure or surgery
Also called OMT, OMM, Osteopathic Manipulative Medicine, Manipulation
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 TouchProcedure or surgery
Also called Sham manipulation, Placebo manipulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual Control Group | No intervention | Not described |
| 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. Receives: Procedure: Light Touch |
| Standard OMT Group | Experimental | Not described Receives: Procedure: Osteopathic Manipulative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subject health status: reviewing data regarding medication usage, co-morbidities, hospitalizations and activities of daily living.
Measured: Five Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General Health StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.T. Still University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen T Snider, DO, Principal investigator, A.T. Still University-Kirksville College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000142
- Sponsor's protocol ID
- 501-332
- Status last verified
- Sep 2018
- First submitted
- 20 Oct 2009
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22904246
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventative OMT and the Nursing Home Patient
- ClinicalTrials.gov ID
- NCT01000142
- Acronym / sponsor ID
- 501-332
- Conditions
- General Health Status
- Keywords
- Osteopathic, Manipulation, Preventative, Elderly, Nursing Home, Prevention: General Health Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- A.T. Still University of Health SciencesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual Control Group | No intervention | – |
| Light Touch Group | Sham comparator | Procedure: Light TouchFocused 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. |
| Standard OMT Group | Experimental | Procedure: Osteopathic Manipulative Treatment |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Resident of Participating Nursing Home
- Life Expectancy of at Least 6 Months
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentAlso: OMT, OMM, Osteopathic Manipulative Medicine, ManipulationFocused 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). | Procedure or surgery | Standard OMT Group |
| Light TouchAlso: Sham manipulation, Placebo manipulationFocused 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 or surgery | Light Touch Group |
Primary outcome
Changes in subject health status: reviewing data regarding medication usage, co-morbidities, hospitalizations and activities of daily living.
Time frame: Five Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Derived from this study: PubMed 22904246Snider 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen T Snider, DO principal investigator
A.T. Still University-Kirksville College of Osteopathic Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment and Light Touch in people with General Health Status, run by A.T. Still University of Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in subject health status: reviewing data regarding medication usage, co-morbidities, hospitalizations and activities of daily living. (time frame: Five Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.