Management of Chronic Pain in Military Patients With Injuries Sustained During Active Duty

The study population includes combat-injured patients and other patients injured while on
active duty who experience chronic pain as a result of the injury and who receive treatment
as active duty military personnel at Department of Defense facilities or through the
Department of Veteran's Affairs. The population will include patients with pain related to
limb amputation, and patients eligible for care in the Veteran's Administration Polytrauma
Network program (Polytrauma Veterans) or for management of similar injuries within the
Department of Defense health care system. Study subjects will have complex problems that are
difficult to treat with current standard rehabilitative approaches. The circumstances of
these patients' injuries create a substantial societal interest in determining and providing
the best achievable rehabilitation, an interest that combines the expectation that medical
science will advance the quality of medical care, practical benefits to subjects and society
of returning patients to active duty or employment, and the moral imperative to support
persons injured while defending our national security.

Inclusion Criteria:

- Subject is a veteran or active duty service member injured while on active military
duty receiving care for pain related to the injury(ies) in the Department of Defense
health care system or through the Department of Veteran's Affairs.

- Subject is 18 years of age or older.

- The elapsed time since the active-duty injury leading to chronic pain is not less
than 3 months.

- Subject reports constant or daily episodes of injury-related pain of at least
moderate severity, graded 4 or higher on an 11-point NPRS (point estimate by subject
and Investigator at time of enrolment based on overall pain or pain at a specific
site). Pain may be nociceptive, neuropathic, or mixed. Phantom pain associated with
amputation of an extremity or extremities is allowed.

- Attempts to control pain with commercially available systemic analgesics have not
provided adequate relief, in the judgment of the managing physician and subject.

- Subject is able to localize site(s) of pain. At least one site of daily pain
contributing to moderate severity (Inclusion Criterion 4) and intractability
(Inclusion Criterion 5) must be in an extremity, or phantom pain at the site of an
amputated extremity. If the extremity site of pain is not an amputated limb, then the
pain must have a neuropathic component. This site is identified as the site of Target
Pain (TP) for efficacy evaluations during the trial.

- Subject is an acceptable candidate for surgical placement of an indwelling spinal
cord stimulation device.

- Subject is judged an appropriate candidate for treatment using the available
techniques and interventions encompassed within the protocol's definition of
comprehensive medical management.

- For the duration of the trial, subject is willing to limit interventions for control
of chronic pain to those approved by the Investigator.

- The subject is judged psychologically appropriate for either treatment intervention,
based on the impression of an interviewing psychologist or psychiatrist.

- Subject provides informed consent.

Exclusion Criteria:

- Subject experiences phantom pain associated with amputation of both an upper and
lower extremity.

- Subject has headache or visceral truncal pain or other non-musculoskeletal pain as
the only pain that results in constant or daily scores of ≥4 on the 11-point NPRS.

- Subject has spinal disease that would, in the judgment of the investigator, - Subject
has ongoing chronic infection or a medical condition associated with an unacceptably
increased risk of infection related to device implantation.

- Subject has a current diagnosis or history of psychosis, cognitive impairment,
hallucinations, or unexplained loss of consciousness, whether or not related to a
combat injury that, in the opinion of the investigator, would exclude the patient
from participating in the trial.

- Subject has a cardiac pacemaker.

- Subject has any significant medical or psychiatric condition that would interfere
with the conduct of the study or with the outcome measures.

- Subject is pregnant or is breast feeding.

- Subject has participated in any drug or device trial in the past 30 days.

- Subject has any planned elective or semi-elective surgery during the 6 months of the
Primary Treatment Phase, including stump revisions or grafting.

- Subject has a psychological condition of great enough severity that it would
unacceptably increase the medical risks associated with implantation and care of the
devices required for the treatment on the CMM + SCS arm, or would likely interfere
with the subject's ability to sustain participation in a research study of long
duration. Investigators are encouraged to include the medical monitor and the
coordinating investigator in discussions about individual candidate subjects who have
psychological diagnoses as part of the polytrauma syndrome before enrollment or
treatment on this protocol.