Extremity InjuryPhase 4War WoundedNCT01616342
Management of Chronic Pain in Military Patients With Injuries Sustained During Active Duty
A Phase 4 study testing Spinal cord stimulator in people with Extremity Injury, run by Sceptor Pain Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Extremity Injury
- What is being tested?
- Spinal cord stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Clinical Research
Winston-Salem, North Carolina, 27103
Jason Kyung-soo Hong, MD, 336-765-6181 ext. 140, jhong@ccrpain.com
Richard Rauck, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Extremity Injury
- Being tested
- Spinal cord stimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulatorDevice
Precise (TM) spinal cord stimulator from boston scientific, and comprehensive mdedical management.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Medical Management | Active comparator | Comprehensive Medical Management will include analgesic management in accordance with guidelines and practices at the site. Receives: 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). Receives: Device: Spinal cord stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 144 weeks
Secondary outcomes (22)
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.
Measured: 144 weeks
change in mean daily pain score
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 144 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extremity InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sceptor Pain Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Richard Rauck, MD, Principal investigator, The Center for Clinical ResearchDerry Ridgeway, MD, Study chair, SRA International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616342
- Sponsor's protocol ID
- 29SEPT2011
- Acronym
- War Wounded
- Status last verified
- Jun 2012
- First submitted
- 26 Oct 2011
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01616342
- Acronym / sponsor ID
- War Wounded / 29SEPT2011
- Conditions
- Extremity Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sceptor Pain FoundationUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Medical Management | Active comparator | Device: Spinal cord stimulatorComprehensive Medical Management will include analgesic management in accordance with guidelines and practices at the site. |
| Spinal Cord Stimulation (SCS) | Active comparator | Device: Spinal cord stimulatorSubjects assigned to Arm A, CMM + SCS, will be treated with electrical pulses from a surgically implanted Precision Plus® SCS System (Boston Scientific Corporation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal cord stimulatorPrecise (TM) spinal cord stimulator from boston scientific, and comprehensive mdedical management. | Device | Comprehensive Medical Management, Spinal Cord Stimulation (SCS) |
Primary outcome
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.
22 secondary outcomes
change in related pain
Time frame: 144 weeks
change in mean daily pain score
Time frame: 144 weeks
change in mean pain per treatment group
Time frame: 144 weeks
change in MPQ per treatment group
Time frame: 144 weeks
change in spine related pain
Time frame: 144 weeks
change in neuropathic pain
Time frame: 144 weeks
analgesic efficacy
Time frame: 144 weeks
pain relief using a categorical scale
Time frame: 144 weeks
change in mood
Time frame: 144 weeks
change in emotional status
Time frame: 144 weeks
change in anxiety
Time frame: 144 weeks
change in quality of life
Time frame: 144 weeks
effectiveness of intervention
Time frame: 144 weeks
Functional effectiveness of intervention
Time frame: 144 weeks
Functional effectiveness of interventions via activity scores
Time frame: 144 weeks
change in sleep
Time frame: 144 weeks
urine drug tests
Time frame: Baseline, week 6, week 12, week 24
Effect of demographic characteristics
Time frame: 144 weeks
predictive value of the change in NPRS average pain scores
Time frame: Week 24, Week 48, Week 96, and Week 144
Analgesic benefit
Time frame: 144 weeks
Safety and tolerability of analgesic interventions
Time frame: 144 weeks
Tolerability of analgesic interventions
Time frame: 144 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- Sceptor Pain FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Rauck, MD principal investigator
The Center for Clinical Research
Derry Ridgeway, MD study chair
SRA International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinal cord stimulator in people with Extremity Injury, run by Sceptor Pain Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score (time frame: 144 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.