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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

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 weeks, 6 weeks, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Balance

Change in Gait

Secondary study objectives

Change in Cognition

Change in Depressed Mood

Change in Motor Skills

+1 more

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)

2021

Completed Phase 4

~400

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