Parkinson's DiseaseNCT02344485
Effect of Osteopathic Manipulative Medicine on Constipation in Parkinson's Disease
A study testing OMM treatment in people with Parkinson's Disease and Constipation, run by New York Institute of Technology at 1 site in United States.
Trial summary
The aim of this pilot study is to investigate the effect of Osteopathic Manipulative Medicine (OMM) in decreasing constipation symptoms in people with Parkinson's disease (PD). A second but optional aim is to determine if OMM changes the bacterial flora of the mouth and gut. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease, Constipation
- What is being tested?
- OMM treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to 31 Dec 2024
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically diagnosed with Parkinson's disease
- Medically diagnosed with constipation (according to Rome III criteria)
- Be over 40 years old
Who cannot join
- No diagnosis of Parkinson's disease
- No diagnosis of constipation that satisfies Rome III criteria
- Medically diagnosed with irritable bowel syndrome
- Another diagnosed cause for chronic constipation
- Currently pregnant
- Have another diagnosed neurologic condition (excluding headache or migraine, headache, migraine, dysautonomia, depression or other mood disorders (unless severe or uncontrolled), dementia or cognitive changes (unless severe), diffuse lewy body dementia, REM sleep behavior disorder, normal pressure hydrocephalus, multiple system atrophy P and C types, progressive supranuclear palsy, vascular parkinsonism, corticobasal ganglionic degeneration, and drug induced parkinsonism)
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- Spinal cord abnormality or lesion
- Cancer of the gastrointestinal tract, abdomen, or pelvis
- Anemia that has not been evaluated
- Unexplained weight loss, fever, night sweats, rectal bleeding, or black stools in past 2 months
- Active hepatitis, infectious mononucleosis, or enlarged spleen
- Abdominal aortic aneurysm
- Congenital malformation of the gastrointestinal tract
- Abdominal or pelvic surgery within the past 6 weeks
- Unable or unwilling to receive OMT.
- Unable or unwilling to rate one's own stools using a visual chart or to bring a picture of one's stool to each visit
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York Institute of Technology- Academic Health Care Center
Old Westbury, New York, 11568
Brian Harper, M.D., 516-686-1300, bharper@nyit.edu
Sheldon Yao, D.O.
About this study
The aim of this pilot study is to investigate the effect of Osteopathic Manipulative Medicine (OMM) in decreasing constipation symptoms in people with Parkinson's disease (PD). A second but optional aim is to determine if OMM changes the bacterial flora of the mouth and gut. OMM is a safe and gentle manual treatment provided by osteopathic physicians. All participants will receive OMM during the second half of the eleven week trial.
Read the detailed description
PD is a progressive neurodegenerative disorder which includes motor and non-motor (autonomic) symptoms, such as constipation. OMM has been shown to improve constipation symptoms in non-diseased subjects and cerebral palsy subjects. Constipation will be measured before, during, and after treatment by a constipation scoring system (Cleveland Criteria) to measure the severity of constipation and by the Bristol Stool Scale to measure colonic transit time. The study subjects' assessment of their constipation symptoms (PAC-SYM) and quality of life (PAC-QOL) will also be measured throughout the study.
Studies have also shown that there is a difference in the gut and oral bacterial flora of constipated versus healthy adults, so subjects will be given the option to provide weekly stool samples for analysis to track bacterial colonies and to observe for any flora changes over the study period. This will provide data to determine if bacterial colonies in stool are altered by OMM.
The study will require ten weekly on-site visits over the course of eleven weeks. For the first half of the study, surveys and optional stool tests will be performed without OMM treatment for four weeks to obtain baseline data. For the second half of the study, all subjects will receive OMM for four weeks along with surveys and optional stool microbial tests to obtain the experimental data.
- Conditions
- Parkinson's Disease, Constipation
- Being tested
- OMM treatment
- Medical subject headings
- Parkinson Disease, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMM treatmentProcedure or surgery
Also called OMM (Osteopathic Manipulative Medicine), OMT (Osteopathic Manipulative Treatment), Osteopathic manipulation
OMM is a gentle hands-on treatment that helps to reduce myofascial restrictions and improve joint range of motion. In doing so, it can address the mechanical, neurologic, and respiratory functions of the body
| Study group | Role | What they receive |
|---|---|---|
| OMM treatment | Experimental | Subject will receive osteopathic manipulative treatment protocol for constipation in Parkinson's disease once a week for 4 weeks, in addition to continuing with their routine care Receives: Procedure: OMM treatment |
| Control | No intervention | Subjects will continue with their routine care. No OMM will be performed during this study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Scoring System (Cleveland Criteria)
A standardized form measuring bowel movement patterns will be completed by the subject five times over the study period to see if there is a difference in constipation severity between the period with no OMT and the period with OMT
Measured: 11 week period
Secondary outcomes (3)
Bristol Stool Scale
A visual standardized stool chart will be used by the subject and study investigator nine times over the study period to visually categorize the shape of the stools to see if there is a difference in colonic transit time between the period with no OMT and the period with OMT
Measured: 11 week period
PAC-SYM©
A standardized form will be completed by the subject five times over the study period to assess constipation symptoms to see if there is a difference between the period with no OMT and the period with OMT
Measured: 11 week period
PAC-QOL©
A standardized form will be completed by the subject five times over the study period to assess the impact of constipation on daily life to see if there is a difference between the period with no OMT and the period with OMT
Measured: 11 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayme Mancini, D.O., Principal investigator, New York Institute of Technology- Academic Health Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344485
- Sponsor's protocol ID
- BHS-1065
- Status last verified
- Nov 2023
- First submitted
- 16 Jan 2015
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathic Manipulative Medicine on Constipation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02344485
- Acronym / sponsor ID
- BHS-1065
- Conditions
- Parkinson's Disease, Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2015
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jan 2015 (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.
The aim of this pilot study is to investigate the effect of Osteopathic Manipulative Medicine (OMM) in decreasing constipation symptoms in people with Parkinson's disease (PD). A second but optional aim is to determine if OMM changes the bacterial flora of the mouth and gut. OMM is a safe and gentle manual treatment provided by osteopathic physicians. All participants will receive OMM during the second half of the eleven week trial.
Detailed description
PD is a progressive neurodegenerative disorder which includes motor and non-motor (autonomic) symptoms, such as constipation. OMM has been shown to improve constipation symptoms in non-diseased subjects and cerebral palsy subjects. Constipation will be measured before, during, and after treatment by a constipation scoring system (Cleveland Criteria) to measure the severity of constipation and by the Bristol Stool Scale to measure colonic transit time. The study subjects' assessment of their constipation symptoms (PAC-SYM) and quality of life (PAC-QOL) will also be measured throughout the study.
Studies have also shown that there is a difference in the gut and oral bacterial flora of constipated versus healthy adults, so subjects will be given the option to provide weekly stool samples for analysis to track bacterial colonies and to observe for any flora changes over the study period. This will provide data to determine if bacterial colonies in stool are altered by OMM.
The study will require ten weekly on-site visits over the course of eleven weeks. For the first half of the study, surveys and optional stool tests will be performed without OMM treatment for four weeks to obtain baseline data. For the second half of the study, all subjects will receive OMM for four weeks along with surveys and optional stool microbial tests to obtain the experimental data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMM treatment | Experimental | Procedure: OMM treatmentSubject will receive osteopathic manipulative treatment protocol for constipation in Parkinson's disease once a week for 4 weeks, in addition to continuing with their routine care |
| Control | No intervention | –Subjects will continue with their routine care. No OMM will be performed during this study period |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medically diagnosed with Parkinson's disease
- Medically diagnosed with constipation (according to Rome III criteria)
- Be over 40 years old
Key exclusion criteria (16 listed)
- No diagnosis of Parkinson's disease
- No diagnosis of constipation that satisfies Rome III criteria
- Medically diagnosed with irritable bowel syndrome
- Another diagnosed cause for chronic constipation
- Currently pregnant
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 |
|---|---|---|
| OMM treatmentAlso: OMM (Osteopathic Manipulative Medicine), OMT (Osteopathic Manipulative Treatment), Osteopathic manipulationOMM is a gentle hands-on treatment that helps to reduce myofascial restrictions and improve joint range of motion. In doing so, it can address the mechanical, neurologic, and respiratory functions of the body | Procedure or surgery | OMM treatment |
Primary outcome
Constipation Scoring System (Cleveland Criteria)
Time frame: 11 week period
A standardized form measuring bowel movement patterns will be completed by the subject five times over the study period to see if there is a difference in constipation severity between the period with no OMT and the period with OMT
3 secondary outcomes
Bristol Stool Scale
Time frame: 11 week period
PAC-SYM©
Time frame: 11 week period
PAC-QOL©
Time frame: 11 week period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Jayme Mancini, D.O. principal investigator
New York Institute of Technology- Academic Health Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMM treatment in people with Parkinson's Disease and Constipation, run by New York Institute of Technology at 1 site 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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jayme Mancini, D.O. (516-686-1237, jmancini@nyit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation Scoring System (Cleveland Criteria) (time frame: 11 week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2023.