Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive Medical Management | Active Comparator | Comprehensive Medical Management will include analgesic management in accordance with guidelines and practices at the site. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal cord stimulator | Device | Precise (TM) spinal cord stimulator from boston scientific, and comprehensive mdedical management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in related pain | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Rauck, MD | The Center for Clinical Research | Principal Investigator |
| Derry Ridgeway, MD | SRA International | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Research | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
Not provided
| Label | URL |
|---|---|
| Sceptor Pain Foundation | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |