OMT for Parkinson's Disease
((OMT/PD) Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?Parkinson's disease (PD) is a neurological disorder that puts individuals at high risk for injuries and long-term disabilities as a result of a fall or other trauma. Injuries sustained from falls account for many deaths as well as thousands of hospital admissions and nursing home stays every month. Quality of life and even longevity itself is reduced due to the resulting surgeries, immobility, complications and even cognitive impairments that can follow. The proposed study will explore beneficial impact of a treatment modality (OMM/OMT) that may significantly reduce the morbidity of this condition by comparing 6 weeks of OMT versus 6 weeks light touch intervention versus 6 weeks care as usual to improve gait in individuals with PD. Gait will be measured at mid-treatment, post-treatment and 4-week follow-up.

Eligibility Criteria

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.

Inclusion Criteria

You have been diagnosed with Parkinson's Disease that is measured by a specific rating scale.

You scored at least 17 on the Montreal Cognitive Assessment (MoCA).

You are older than 18 years.

+2 more

Participant Groups

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.

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.

Osteopathic Manipulative Treatment (OMT) is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Osteopathic Manipulative Treatment for: