Effect of Osteopathic Manipulative Medicine on Constipation in Parkinson's Disease

NCT02344485 | Unknown

• 1 other identifier: BHS-1065
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson's Disease; Constipation

Outcome Measures

Primary Outcomes (1)

• 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

  11 week period

Secondary Outcomes (3)

• Bristol Stool Scale

  11 week period

• PAC-SYM©

  11 week period

• PAC-QOL©

  11 week period

Other Outcomes (2)

• Stool analysis

  11 week period

• Mouth analysis

  11 week period

Study Arms (2)

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

Procedure: OMM treatment

Control

NO INTERVENTION

Subjects will continue with their routine care. No OMM will be performed during this study period

Interventions

OMM treatment PROCEDURE

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

Also known as: OMM (Osteopathic Manipulative Medicine), OMT (Osteopathic Manipulative Treatment), Osteopathic manipulation

OMM treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically diagnosed with Parkinson's disease
• Medically diagnosed with constipation (according to Rome III criteria)
• Be over 40 years old

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

New York Institute of Technology- Academic Health Care Center

Old Westbury, New York, 11568, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Constipation

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jayme Mancini, D.O.

  New York Institute of Technology- Academic Health Care Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayme Mancini, D.O.

CONTACT

516-686-1237; jmancini@nyit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 26, 2015
• Study Start: January 1, 2015
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)