War Wounded, a Comparison of Two Pain Management Approaches
War Wounded, a Comparison of Two Pain Management Approaches
This study aims to investigate the relative effectiveness of two different pain management
 plans for injuries sustained while active duty in the military. One arm of the study has
 subjects undergo standard comprehensive medical management, while the other adds the
 placement of a spinal cord stimulator, a common procedure for the alleviation of pain.
This study aims to investigate the relative effectiveness of two different pain management
 plans for injuries sustained while active duty in the military. One arm of the study has
 subjects undergo standard comprehensive medical management, while the other adds the
 placement of a spinal cord stimulator, a common procedure for the alleviation of pain.

 This site was never activated for the research by the sponsor.
Inclusion Criteria:

 1. 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.

 2. Subject is 18 years of age or older.

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

 4. 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.

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

 6. 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.

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

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

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

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

 11. Subject provides informed consent.

 Exclusion Criteria:

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

 2. 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.

 3. Subject has spinal disease that would, in the judgment of the investigator, preclude
 placement of a spinal cord stimulator.

 4. Subject has ongoing chronic infection or a medical condition associated with an
 unacceptably increased risk of infection related to device implantation.

 5. 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.

 6. Subject has a cardiac pacemaker.

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

 8. Subject is pregnant or is breast feeding.

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

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

 11. 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.