Effects of Osteopathic Manipulative Treatment (OMT) on Gait Biomechanics in Parkinson's Disease

The overall design proposed in this study is a randomized, placebo controlled, single-blind
controlled trial. Data will be collected in this developmental study to assess potential
differences in gait, balance, and quality of life of patients in the intervention arm (6-week
OMT intervention coupled with standard of care (SOC) versus the light touch comparator arm
(6-week light touch coupled with SOC) versus the non-intervention control arm (SOC alone). As
noted in the previous section, power analyses assuming a clinically significant improvement
in gait and balance indicate that 90 completers per condition will be enough to detect this
medium effect size. To achieve this aim, the investigators will over-recruit to allow for
~20% dropout rate by recruiting a total of 108 participants (36 per condition). The benefit
of OMT as compared to standard care for PD is what is being examined in this study and if
shown beneficial may be a less invasive with fewer side effects that standard care which may
utilize surgery.

Randomization will occur after baseline testing session. Individuals will be randomly
assigned to one of three treatment arms using a computer-generated randomization algorithm
that will determine group assignment in variable blocks of 3 & 6 and stratified by gender.
Study staff completing the assessment sessions will remain naive to treatment condition. All
study staff will be CITI-certified prior to study commencement.

The 6 OMT and the light touch comparator arm sessions will be administered at the UCSD EPARC
offices, or at Osteopathic Center San Diego.

OMT Intervention Arm. Along with SOC, participants assigned to the OMT arm will receive 30
minutes of OMT per week for 6 weeks. Following the precedent of OMT procedures used by Wells
et al., (1999), 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. All of these OMT procedures are used in
standard OMT practice and are gentle non-thrusting maneuvers in general. Further, each
subject will receive cranial assessment and treatment emphasizing the venous sinus techniques
and compression of the fourth ventricle (CV-4). The addition of the CV-4 beyond the 14 areas
assessed and treated in the Wells et al study reflects research that showed CV-4 impact on
sleep latency and muscle sympathetic activity impact on brain oxygen levels as well as alpha
rhythm. The utilization of the venous sinus technique is based on its impact in increasing
blood flow to the circle of Willis and Dr. King's pilot work. The myofascial and other
appropriate OMT procedures are directed at the whole neuromusculoskeleton system and benefit
postural balance and range of motion in general. Given the rare risk of spinal cord injury or
vertebral artery dissection with high velocity, low amplitude techniques, these will not be
utilized on this protocol. Participants undergoing OMT intervention will continue with their
current standard of care.

Comparator Arm (Light Touch) : 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. The subject will feel hand contact, a light touch, but no treatment intention
expressed by the operator verbally or by hand motion. While the operator's hands will be
placed of areas contacted in the OMT protocol, the precise placement will be off, away from,
the real OMT procedures. The intent of the light touch is to apply manual forces of
diminished magnitude purposely aimed to avoid treatable areas of somatic dysfunction relative
to gait and balance dysfunction in PD and, consequently, to minimize the likelihood of any
therapeutic effect.

Standard of Care (SOC) Only. Subjects will continue their usual care and will visit the UCSD
for the 4 assessment sessions only, during their course of study participation.

After the 4-week follow-up assessment visit, all participants assigned to light touch or SOC
arms will be offered the opportunity to receive 6 weeks of OMT, if they so desire.

Inclusion Criteria:

1. Age > 18 years.

2. Ambulatory without use of assistive device.

3. Fluency in written and spoken English.

4. Montreal Cognitive Assessment (MoCA) score > or = 17.

5. Stages 1 - 4 Parkinson's Disease diagnosis as measured by the Unified Parkinson's
disease rating scale.

Exclusion Criteria:

1. Currently enrolled in another clinical trial.

2. Current taking PD medications co-morbid conditions such as pseudobulbar palsy or
amyotrophic lateral sclerosis which may have musculoskeletal effects.

3. Individuals with current fractures, tumors, wounds.

4. Any lifetime Deep Brain Stimulation implant surgery.

5. Recent surgeries, eg., within past 90 days.

6. Patients who have experienced hospitalization due to a fall within the past 12 months.

7. Gait abnormalities other than Parkinson's disease.

8. Received OMT or another forms of manipulative therapy within the past two months.

9. Stage 5 Parkinson's Disease diagnosis per as measured by the Unified Parkinson's
disease rating scale.

10. Other co-morbid conditions that in the opinion of the PI would interfere with
participation in this study.

11. Diagnosis of psychosis or dementia (MoCA, DRS or other indication in eMR).

12. Pregnancy