InjuriesNCT01620411
War Wounded, a Comparison of Two Pain Management Approaches
A study testing Comprehensive Medical Management and Spinal Cord Stimulator in people with Injuries and Pain, run by University of California, San Diego at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- What is being tested?
- Comprehensive Medical Management and Spinal Cord Stimulator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2017
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- 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, preclude placement of a spinal cord stimulator.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Chronic Pain in Military Patients With Injuries Sustained During Active Duty. Comparison of Spinal Cord Stimulation and Comprehensive Medical Management.
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.
Read the detailed description
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.
- Being tested
- Comprehensive Medical Management, Spinal Cord Stimulator
- Keywords
- Active Duty, Comprehensive Medical Management, Spinal Cord Stimulator, Veteran, sustained, military
- Medical subject headings
- Wounds and Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Medical ManagementOther
Standard of care for failed back surgery syndrome sustained while on active duty, primarily focused on physical therapy, medication including: opioid analgesics, muscle relaxants, non-opioid analgesics, etc.
Spinal Cord StimulatorProcedure or surgery
This arm combines comprehensive medical management (as above) with the trial and possible eventual permenant placement of a spinal cord stimulator, a common pain management procedure.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Medical Management (CMM) | Experimental | This arm will receive standard of care treatment for injuries sustained while on active duty. Non-Invasive. Receives: Other: Comprehensive Medical Management |
| CMM + Spinal Cord Stimulator (SCS) | Experimental | This arm will combine comprehensive medical management with placement of a spinal cord stimulator. Receives: Procedure: Spinal Cord Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased Pain Ratings
Pain rating using the Numeric Pain Rating Scale (NPRS) over time. The NPRS is assessing the patients pain on a 11-point rating scale from 0 - 10 with 0 being no pain at all and 10 being the worst imaginable pain. The test is self-reported and can also be administered by an interviewer.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startJun 2012 (estimated)
- Primary completionJun 2016 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: Site was never activated by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuriesStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Moeller-Bertram, University of California, San Diego
- Investigators
- Tobias Moeller-Bertram, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620411
- Sponsor's protocol ID
- 120565
- Status last verified
- Aug 2019
- First submitted
- 13 Jun 2012
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- NCT01620411
- Acronym / sponsor ID
- 120565
- Keywords
- Active Duty, Comprehensive Medical Management, Spinal Cord Stimulator, Veteran, sustained, military
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Site was never activated by sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jun 2012 (estimated)
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 15 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Medical Management (CMM) | Experimental | Other: Comprehensive Medical ManagementThis arm will receive standard of care treatment for injuries sustained while on active duty. Non-Invasive. |
| CMM + Spinal Cord Stimulator (SCS) | Experimental | Procedure: Spinal Cord StimulatorThis arm will combine comprehensive medical management with placement of a spinal cord stimulator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not 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 (11 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, preclude placement of a spinal cord stimulator.
- 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.
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 |
|---|---|---|
| Comprehensive Medical ManagementStandard of care for failed back surgery syndrome sustained while on active duty, primarily focused on physical therapy, medication including: opioid analgesics, muscle relaxants, non-opioid analgesics, etc. | Other | Comprehensive Medical Management (CMM) |
| Spinal Cord StimulatorThis arm combines comprehensive medical management (as above) with the trial and possible eventual permenant placement of a spinal cord stimulator, a common pain management procedure. | Procedure or surgery | CMM + Spinal Cord Stimulator (SCS) |
Primary outcome
Decreased Pain Ratings
Time frame: 3 years
Pain rating using the Numeric Pain Rating Scale (NPRS) over time. The NPRS is assessing the patients pain on a 11-point rating scale from 0 - 10 with 0 being no pain at all and 10 being the worst imaginable pain. The test is self-reported and can also be administered by an interviewer.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Primary Investigator ProfileLink 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.
Tobias Moeller-Bertram principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Medical Management and Spinal Cord Stimulator in people with Injuries and Pain, run by University of California, San Diego 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 11 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: withdrawn, as of the sponsor's last update on 12 Aug 2019. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased Pain Ratings (time frame: 3 years). 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 12 Aug 2019.