Treatment Efficacy of OMT for Carpal Tunnel Syndrome

The incidence of Carpal Tunnel Syndrome (CTS) in adults in the U.S. ranges from 15-20%
depending on the study, and costs over one billion dollars annually in medical care. Surgery
for CTS accounts for much of these costs with up to one third of these patients experiencing
re-occurrence of symptoms post-operatively.

The overall goal for this proposed exploratory clinical trial is to evaluate the efficacy of
a conservative, manual medicine treatment as an adjunctive therapy to standard care for CTS.
This pilot study utilizes a prospective, randomized, placebo-controlled clinical trial
methodology to examine whether an eight week treatment regimen of osteopathic manipulative
treatment (OMT) when used adjunctively to standard therapy will have immediate and lasting
positive effects on the symptoms, functional limitations, and physiologic impairment
associated with CTS.

Male and female subjects between the ages of 20 and 65 who meet electro-physiologic and
symptom/functional inclusion criteria will be randomly assigned to one of three study
groups, all of which will continue standard medical care with their treating
physician/provider; (i) OMT plus standard medical care; (ii) placebo (sub-therapeutic
ultrasound) plus standard medical care; and (iii) standard medical care only (no-treat).

Outcome measures are: 1. Median and Ulnar motor and sensory nerve conduction amplitudes and
distal latencies, 2. Symptoms and Functional status, 3. Strength, 4. Sensation, 5. Interior
dimensions of the carpal tunnel, and 6. Quantification (signal intensity by MRI) of water
(edema) in the Median nerve and carpal tunnel. Placebo potency and blinding success will be
evaluated. A preliminary investigation demonstrates our ability to recruit subjects and
measure these outcomes. Power analysis based upon a decrease in the mean median motor nerve
distal latency of 30% identified a minimum number of 42 subjects per treatment group.

It is expected that a significantly greater number of subjects in the OMT adjunctive
treatment group will achieve the effective change in nerve latency compared to the other two
treatment groups. It is also expected that the OMT adjunctive treatment group will have
greater improvement of all physiological and clinical outcome measures than the other two
groups. It is anticipated that the findings of this preliminary clinical trial will provide
a basis for the development of a multi-center clinical trial to compare the outcomes of
conservative non-surgical manual medicine treatments with the outcomes of surgical
treatments of CTS.

Inclusion Criteria:

- Men and women with a self-reported medical diagnosis of unilateral or bilateral CTS,
between the ages of 21 and 65 and all races and ethnic groups.

- Median motor nerve distal latency greater than 4.2 ms

- A difference between ipsilateral Median and Ulnar motor nerve distal latency greater
than 1.5 ms.

- Median nerve sensory nerve distal latency greater than 2.2 ms

- A difference between Median and Ulnar sensory nerve peak distal latency greater than
0.2 ms

Exclusion Criteria:

- severe CTS that has progressed to muscle atrophy

- pregnancy

- previous wrist surgery on the wrist to be studied

- systemic disease or condition including but not limited to diabetes mellitus, thyroid
disorders, rheumatoid disorders, Paget's bone disease, gout, myxedema, multiple
myeloma, acromegaly, hepatic disease, dialysis patients, or other diseases or
conditions in which peripheral neuropathies are common.

- secondary cause of CTS such as a ganglion cyst, mass, or an accessory muscle shown by
an MRI exam of the wrist.