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

NCT01616342 | Unknown Phase 4 DMC

• 1 other identifier: 29SEPT2011
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the degree to which spinal cord stimulation added to comprehensive medical management can provide increased relief of chronic pain in patients with injuries sustained while on active military duty, measured by patient assessments of pain.

Conditions

Extremity Injury

Outcome Measures

Primary Outcomes (1)

• Change in pain score

  Change from Baseline to Week 24 in weekly mean of average daily pain scores at the target site of pain (target pain, TP), based on an 11-point Numerical Pain Rating Scale (NPRS), by treatment group.

  144 weeks

Secondary Outcomes (22)

• change in related pain

  144 weeks

• change in mean daily pain score

  144 weeks

• change in mean pain per treatment group

  144 weeks

• change in MPQ per treatment group

  144 weeks

• change in spine related pain

  144 weeks

Study Arms (2)

Comprehensive Medical Management

ACTIVE COMPARATOR

Comprehensive Medical Management will include analgesic management in accordance with guidelines and practices at the site.

Device: Spinal cord stimulator

Spinal Cord Stimulation (SCS)

ACTIVE COMPARATOR

Subjects assigned to Arm A, CMM + SCS, will be treated with electrical pulses from a surgically implanted Precision Plus® SCS System (Boston Scientific Corporation).

Device: Spinal cord stimulator

Interventions

Spinal cord stimulator DEVICE

Precise (TM) spinal cord stimulator from boston scientific, and comprehensive mdedical management.

Comprehensive Medical Management; Spinal Cord Stimulation (SCS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sceptor Pain Foundation: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Related Links

• Sceptor Pain Foundation

Study Officials

• Richard Rauck, MD

  The Center for Clinical Research

  PRINCIPAL INVESTIGATOR

• Derry Ridgeway, MD

  SRA International

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: June 11, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 11, 2012

Record last verified: 2012-06

Locations

US (1)