Management of Chronic Pain in Military Patients With Injuries Sustained During Active Duty (War Wounded)

June 7, 2012 updated by: Sceptor Pain Foundation

Investigator Initiated Trial- Management of Chronic Pain in Military Patients With Injuries Sustained During Active Duty. Comparison of Spinal Cord Stimulation and Comprehensive Medical Management

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston Salem, North Carolina, United States, 27103
        • Recruiting
        • Center for Clinical Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Comprehensive Medical Management
Comprehensive Medical Management will include analgesic management in accordance with guidelines and practices at the site.
Device: Spinal cord stimulator
Precise (TM) spinal cord stimulator from boston scientific, and comprehensive mdedical management.
Active Comparator: Spinal Cord Stimulation (SCS)
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
Precise (TM) spinal cord stimulator from boston scientific, and comprehensive mdedical management.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in pain score
Time Frame: 144 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in related pain
Time Frame: 144 weeks
Change from Baseline to Week 24 and Week 144 in subjects' experiences related to pain, using the Pain Outcomes Questionnaire for Veterans Affairs (Intake and Discharge; POQ-VA), by treatment group.
144 weeks
change in mean daily pain score
Time Frame: 144 weeks
Change from Baseline to Week 24 in weekly mean of average daily pain scores for overall pain (OP), based on an 11-point Numerical Pain Rating Scale (NPRS), by treatment group.
144 weeks
change in mean pain per treatment group
Time Frame: 144 weeks
Change from Baseline to Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 36, Week 48, Week 72, Week 96, Week 120, and Week 144 in weekly mean of average daily pain scores for TP and OP, based on the 11-point NPRS, by treatment group.
144 weeks
change in MPQ per treatment group
Time Frame: 144 weeks
Change from Baseline to Week 24, Week 48, Week 96, and Week 144 in pain evaluation, measured by the McGill Pain Questionnaire (MPQ), by treatment group.
144 weeks
change in spine related pain
Time Frame: 144 weeks
Change from Baseline to Week 24, Week 48, Week 96, and Week 144 in spine-related pain, measured by the Modified Oswestry Pain Questionnaire, by treatment group.
144 weeks
change in neuropathic pain
Time Frame: 144 weeks
Change from Baseline to Week 24, Week 48, Week 96, and Week 144 in neuropathic pain, measured by the Neuropathic Pain Scale (NPS), by treatment group
144 weeks
analgesic efficacy
Time Frame: 144 weeks
Overall analgesic efficacy, measured by Investigator and Subject using categorical global scores of change at Week 24 and Week 144 (GIC-I, GIC-S), by treatment group.
144 weeks
pain relief using a categorical scale
Time Frame: 144 weeks
Assessment of pain relief, measured by the Subject using a categorical 5-point scale (None =0, A Little =1, Some =2, A Lot =3, or Complete =4) at Week 24 and Week 144, by treatment group
144 weeks
change in mood
Time Frame: 144 weeks
Change from Baseline to Week 24, Week 48, Week 96, and Week 144 in patient mood, measured by the Profile of Mood Survey (POMS), by treatment group.
144 weeks
change in emotional status
Time Frame: 144 weeks
Change from Baseline to Week 24, Week 48, Week 72, and Week 144 in patient emotional status (mood), measured by the Beck Depression
144 weeks
change in anxiety
Time Frame: 144 weeks
Change from Baseline to Week 24, Week 48, Week 72, and Week 144 in patient anxiety, measured by the Impact of Events - Revised (IES-R) scale and by the Post Traumatic Stress Disorder Checklist (PCL), by treatment group.
144 weeks
change in quality of life
Time Frame: 144 weeks
Change from Baseline to Week 24, Week 48, Week 96, and Week 144 in quality of life, measured by the SF-36 Health Survey, by treatment group.
144 weeks
effectiveness of intervention
Time Frame: 144 weeks
Overall effectiveness of intervention as measured by number (%) of subjects who withdraw prior to Week 24, prior to Week 48, prior to Week 96, and prior to Week 144, due to lack of efficacy.
144 weeks
Functional effectiveness of intervention
Time Frame: 144 weeks
Functional effectiveness of intervention as measured by number (%) of subjects who return to duty (active duty subjects) or return to employment (subjects treated as veterans) at Week 24, Week 48, Week 96, and Week 144.
144 weeks
Functional effectiveness of interventions via activity scores
Time Frame: 144 weeks
Functional effectiveness of interventions as measured by daily mean and peak activity scores and numbers of days with sedentary or moderate activity levels based on data downloads from the 3-D accelerometer at Baseline, during the 2-week interval prior to Week 12, and for the 2-week intervals preceding visits at Week 24, Week 48, Week 96, and Week 144.
144 weeks
change in sleep
Time Frame: 144 weeks
Change in Chronic Pain Sleep Inventory (CPSI), Baseline to Week 24, Week 48, Week 96, and Week 144, by treatment group.
144 weeks
urine drug tests
Time Frame: Baseline, week 6, week 12, week 24
Number (percentage) and change from Baseline in number (percentage) of subjects with non-adherence to the prescribed analgesic drug regimen (detection of non-prescribed medication/metabolite or non-detection of prescribed medication/metabolite) on urine drug tests (UDT), at Baseline, Week 6, Week 12, and Week 24.
Baseline, week 6, week 12, week 24
Effect of demographic characteristics
Time Frame: 144 weeks
Effect of demographic characteristics, combat exposure (measured by the combat exposure scale administered at Baseline), elapsed time since injury, site of injury, and type of injury (blast injury, penetrating wound, burn, amputation, combat versus non-combat, other) on the effectiveness of intervention measured by the subject reports of pain and pain relief, overall effectiveness scores, and efficacy scales, by treatment group.
144 weeks
predictive value of the change in NPRS average pain scores
Time Frame: Week 24, Week 48, Week 96, and Week 144
For subjects assigned to Arm A (CMM + SCS), the predictive value of the change in NPRS average pain scores (both TP and OP) from Baseline to the pre-implantation trial week for the scores observed at Week 24, Week 48, Week 96, and Week 144.
Week 24, Week 48, Week 96, and Week 144
Analgesic benefit
Time Frame: 144 weeks
Analgesic benefit of crossover to the non-assigned treatment arm, measured in subjects who change from the assigned arm to the alternative arm before Week 24, using the efficacy assessments recorded prior to crossover (removal or implantation of the SCS device), summarized as LOCF values at Week 24, with efficacy assessments during the weeks following the crossover event, counted as if the crossover event initiated (re-started) the Primary Treatment Phase.
144 weeks
Safety and tolerability of analgesic interventions
Time Frame: 144 weeks
Safety and tolerability of analgesic interventions, measured by spontaneously reported adverse events, serious adverse events, and adverse events leading to early withdrawal, by treatment group.
144 weeks
Tolerability of analgesic interventions
Time Frame: 144 weeks
Tolerability of analgesic interventions as measured by total number of hospital days experienced by the subject, including hospital days required for study-related interventions and hospital days resulting from adverse events and in-patient management of pain.
144 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sceptor Pain Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Rauck, MD, The Center for Clinical Research
  • Study Chair: Derry Ridgeway, MD, SRA International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 29SEPT2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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