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OMT for Parkinson's Disease ((OMT/PD) Trial)
N/A
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 weeks, 6 weeks, and 10 weeks
Awards & highlights
(OMT/PD) Trial Summary
This trial will explore whether a treatment modality (OMM/OMT) can reduce the morbidity of Parkinson's disease by comparing 6 weeks of OMT to 6 weeks of light touch intervention to 6 weeks of care as usual.
Who is the study for?
This trial is for adults over 18 with Parkinson's Disease stages 1-4 who can walk without help and speak English. They must have a MoCA score of at least 17, indicating basic cognitive function.Check my eligibility
What is being tested?
The study tests if Osteopathic Manipulative Treatment (OMT) improves walking in Parkinson's patients compared to light touch or usual care. It measures changes in gait after 6 weeks of treatment and again at a follow-up four weeks later.See study design
What are the potential side effects?
OMT is generally considered safe but may include temporary discomfort, pain or soreness where treated. Light touch is non-invasive and not expected to cause side effects.
(OMT/PD) Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 weeks, 6 weeks, and 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 weeks, 6 weeks, and 10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Balance
Change in Gait
Secondary outcome measures
Change in Cognition
Change in Depressed Mood
Change in Motor Skills
+1 more(OMT/PD) Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Osteopathic Manipulative Treatment (OMT)Experimental Treatment1 Intervention
Participants assigned to the OMT arm will receive 6 weekly sessions. The provider will perform the following 14 osteopathic procedures 1) lateral (and anteroposterior) translation of vertebrae in the thoracic/lumbar spine; 2) active myofascial stretch to the thoracic spine; 3) occipito-atlanto release; 4) translation of cervical spine; 5) muscle energy techniques of the cervical spine; 6) Spencer technique applied to the shoulder bilaterally; 7) supination/pronation of the forearm; 8) circumduction of the wrist; 9) sacroiliac joint gapping; 10) muscle energy technique applied to adductor muscles of lower extremity; 11) psoas muscle energy technique; 12) hamstring muscle energy technique; 13) articulatory technique applied to the ankle; 14) and muscle energy technique applied to the ankle in dorsi and plantar flexion. Further, each subject will receive cranial assessment and treatment emphasizing the venous sinus techniques and compression of the fourth ventricle (CV-4).
Group II: Standard of Care OnlyActive Control1 Intervention
Subjects will continue their usual care and will visit the UCSD for the 4 assessment sessions only, during their course of study participation.
Group III: Light TouchPlacebo Group1 Intervention
Participants assigned to the light touch comparator arm will receive 30 minutes of light touch procedures designed to be credible but minimally effective. The procedures for the light touch arm are adapted from the methodology established in the North Texas Chronic Low Back Pain Trial, and have been used successfully by the PI as a comparator arm numerous times in the past (e.g., in the OSTEPAThic Trial). Subjects assigned to receive light touch will be treated in positions similar to subjects receiving OMT. Light touch will target each of the 15+ anatomic regions for approximately 1 ½ to 2 minutes each to appropriately control for time, attention, and physical contact. Light touch hand placement will be over the same areas of the body contacted in the OMT protocol, but involve virtually no motion of a meaningful nature, such a range of motion testing which could have therapeutic effect.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osteopathic Manipulative Treatment (OMT)
2019
Completed Phase 4
~290
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,313 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still available for this experiment?
"According to the details on clinicaltrials.gov, this particular research endeavor is not actively looking for volunteers anymore; it was initially posted in July 2018 and last modified on June 17th 2022. But there are 488 other trials that have open enrolment at present."
Answered by AI
What outcomes is this experiment seeking to accomplish?
"The primary focus of the study, to be monitored over 0 weeks, 6 weeks, and 10 weeks is a Change in Gait. Additional objectives involve measuring Changes in PD-Related Health Status (assessed by Parkinsons disease Questionnaire-39), Cognition (utilizing Montreal Cognitive Assessment) and Depressed Mood (Geriatric Depression Scale)."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
65+
What site did they apply to?
University of California, San Diego
What portion of applicants met pre-screening criteria?
Met criteria
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