Peripheral NeuropathyNCT02701075
MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain
A study testing MC5-A Scrambler Therapy in people with Peripheral Neuropathy and Low Back Pain, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
The FDA-approved MC5-A Scrambler Therapy (MC5-A ST) is an electroanalgesia device that interferes with pain signal transmission by using nerve fibers as a passive means to convey a message of normality (sans pain) to the central nervous system. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Peripheral Neuropathy, Low Back Pain
- What is being tested?
- MC5-A Scrambler Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 31 Aug 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- military service members (active duty \& retirees) between the ages of 18 and 79, inclusive
- neuropathic pain symptoms present for 3 months or greater prior to entry into the study
- rated pain intensity equal to or greater than 3 on NRS-11 pain scale
- painful peripheral neuropathy in an extremity that is the result of a traumatic injury (post-traumatic/ post-surgical neuropathy, stump pain, entrapment neuropathy), or low back pain with radiculopathy
- stable pain medication treatment regimen
- able to speak and read English, understand the study procedures, and consent to study participation
Who cannot join
- pacemaker or other implantable devices
- vena cava, aneurysm clips, coronary or other vascular stents
- pregnancy via a pregnancy test
- history of epilepsy, brain injury, symptomatic brain metastases
- prior celiac plexus block, or other neurolytic pain control treatment, within 4 weeks
- wounds or skin irritation in areas where the electrodes are required to be placed
Show all 15Show fewer
- cardiac ischemia within the previous 6 months
- severe arrhythmia
- documented history of moderate or severe traumatic brain injury
- latex allergies
- open wound over site of chronic pain
- unable to stop anti-epileptic medications or gabapentin over 2 weeks of MC5-A ST treatment
- history of electroanalgesia treatment (electroacupuncture, biomodulator, TENS) over last 30 days
- participation in the study would delay the medical board (MEB) processing of the service member off of active duty status or would delay a return to duty status to their home unit.
- metal implants such as cardiac pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
The FDA-approved MC5-A Scrambler Therapy (MC5-A ST) is an electroanalgesia device that interferes with pain signal transmission by using nerve fibers as a passive means to convey a message of normality (sans pain) to the central nervous system. While preliminary research has demonstrated its efficacy in treating chronic neuropathic pain secondary to cancer and failed back surgery syndrome, its effectiveness in treating chronic neuropathic pain secondary to traumatic musculoskeletal injuries like those experienced in combat has not been investigated. The purpose of this prospective, double-blind, randomized controlled, study is to determine if the MC5-A ST is efficacious in altering the biological, psychological, and social components of the chronic neuropathic pain experience in military Service Members (SMs) with traumatic musculoskeletal extremity injuries.
- Conditions
- Peripheral Neuropathy, Low Back Pain
- Being tested
- MC5-A Scrambler Therapy, MC5-A Scrambler Therapy Sham Device
- Keywords
- peripheral neuropathy, traumatic tissue injury, radiculopathy
- Medical subject headings
- Peripheral Nervous System Diseases, Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC5-A Scrambler TherapyDevice
Also called Calmare
up to 10 sessions, each session lasting 30 minutes
MC5-A Scrambler Therapy Sham DeviceDevice
Also called Calmare Sham
up to 10 sessions, each session lasting 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| MC5-A Scrambler Therapy | Experimental | MC5-A Scrambler Therapy is an electroanalgesia device that interferes with pain signal transmission by using nerve fibers as a passive means to convey a no pain message to the central nervous system. Electrodes are placed on dermatomes that correspond to the area of pain. Patient is treated for 30 minutes and given up to 10 treatment sessions. Receives: Device: MC5-A Scrambler Therapy |
| MC5-A Scrambler Therapy Sham Device | Sham comparator | The MC5-A Scrambler Therapy Device will be used as an active sham device in this randomized double blind study. Participants assigned to this arm will not receive active therapy. Receives: Device: MC5-A Scrambler Therapy Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11)
Measured: Baseline, Week 3, Week 6
Secondary outcomes (1)
Change over time in oral consumption of analgesic medications
Measured: Baseline, Week 3, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startSep 2013
- Primary completionDec 2016
- Study completion31 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Ann Marie Nayback-Beebe, PhD, RN, Brooke Army Medical Center
- Investigators
- Ann Marie Nayback-Beebe, PhD, FNP-BC, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701075
- Sponsor's protocol ID
- TSNRP-N13-04
- Status last verified
- Feb 2017
- First submitted
- 22 Jan 2014
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain
- ClinicalTrials.gov ID
- NCT02701075
- Acronym / sponsor ID
- TSNRP-N13-04
- Conditions
- Peripheral Neuropathy, Low Back Pain
- Keywords
- peripheral neuropathy, traumatic tissue injury, radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- 31 Aug 2017 (estimated)
- First posted
- 8 Mar 2016 (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 FDA-approved MC5-A Scrambler Therapy (MC5-A ST) is an electroanalgesia device that interferes with pain signal transmission by using nerve fibers as a passive means to convey a message of normality (sans pain) to the central nervous system. While preliminary research has demonstrated its efficacy in treating chronic neuropathic pain secondary to cancer and failed back surgery syndrome, its effectiveness in treating chronic neuropathic pain secondary to traumatic musculoskeletal injuries like those experienced in combat has not been investigated. The purpose of this prospective, double-blind, randomized controlled, study is to determine if the MC5-A ST is efficacious in altering the biological, psychological, and social components of the chronic neuropathic pain experience in military Service Members (SMs) with traumatic musculoskeletal extremity injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MC5-A Scrambler Therapy | Experimental | Device: MC5-A Scrambler TherapyMC5-A Scrambler Therapy is an electroanalgesia device that interferes with pain signal transmission by using nerve fibers as a passive means to convey a no pain message to the central nervous system. Electrodes are placed on dermatomes that correspond to the area of pain. Patient is treated for 30 minutes and given up to 10 treatment sessions. |
| MC5-A Scrambler Therapy Sham Device | Sham comparator | Device: MC5-A Scrambler Therapy Sham DeviceThe MC5-A Scrambler Therapy Device will be used as an active sham device in this randomized double blind study. Participants assigned to this arm will not receive active therapy. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- military service members (active duty \& retirees) between the ages of 18 and 79, inclusive
- neuropathic pain symptoms present for 3 months or greater prior to entry into the study
- rated pain intensity equal to or greater than 3 on NRS-11 pain scale
- painful peripheral neuropathy in an extremity that is the result of a traumatic injury (post-traumatic/ post-surgical neuropathy, stump pain, entrapment neuropathy), or low back pain with radiculopathy
- stable pain medication treatment regimen
Key exclusion criteria (15 listed)
- pacemaker or other implantable devices
- vena cava, aneurysm clips, coronary or other vascular stents
- pregnancy via a pregnancy test
- history of epilepsy, brain injury, symptomatic brain metastases
- prior celiac plexus block, or other neurolytic pain control treatment, within 4 weeks
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 |
|---|---|---|
| MC5-A Scrambler TherapyAlso: Calmareup to 10 sessions, each session lasting 30 minutes | Device | MC5-A Scrambler Therapy |
| MC5-A Scrambler Therapy Sham DeviceAlso: Calmare Shamup to 10 sessions, each session lasting 30 minutes | Device | MC5-A Scrambler Therapy Sham Device |
Primary outcome
Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11)
Time frame: Baseline, Week 3, Week 6
1 secondary outcome
Change over time in oral consumption of analgesic medications
Time frame: Baseline, Week 3, Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Ann Marie Nayback-Beebe, PhD, FNP-BC principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MC5-A Scrambler Therapy in people with Peripheral Neuropathy and Low Back Pain, run by Brooke Army Medical Center 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 6 inclusion and 15 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 7 Feb 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11) (time frame: Baseline, Week 3, Week 6). 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 7 Feb 2017.