Neuropathic PainPTP-NPNCT02979925
Improving Functions in Veterans With Post-traumatic Peripheral Neuropathic Pain
A study testing Active Transcutaneous Magnetic Stimulation in people with Neuropathic Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The proposed study will set the foundation for future multi-center studies. To validate tMS as a non-contact and non-invasive pain treatment option for reducing pain in Veterans with PTP-NP and improving their overall functions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Active Transcutaneous Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- Subject is willing and able to comply with scheduled visits, treatment plan, daily pain, sleep and all study related assessments and procedures
- Subjects must be literate in the language used in the assessments and pain diary
- Veterans (men or women) of any race or ethnicity who are at least 18 years of age
- Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 7 days after the last session of the assigned treatment
- A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active
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- Subject must have chronic peripheral neuropathic pain present for more than 4 months after a traumatic or surgical event per medical history, this may include, for example:
- motor vehicle accident
- fall
- sports injury
- knee or hip replacement
- hernia repair
- thoracotomy
- mastectomy
- focal/localized burns or crush injury
- In addition, to be eligible for inclusion in the study, all subjects must:
- have an average daily Numerical Pain Rating Scale (NPRS) score >3 during B1; and
- have a spontaneous pain intensity >30 on 0-100 Mechanical Visual Analogue Scale (M-VAS) to be eligible for randomization
- Must have their implicated peripheral nerve(s) identified
- Must meet criteria for neuropathic pain assessment to meet eligibility for the study [46]. Pain distribution across a nerve territory and history indicates relevant lesion or disease plus criteria listed in a and/or b
- (A): At least one negative or positive sensory sign or symptom confined to innervation territory of the lesioned nervous structure. Examples of negative or positive signs or symptoms include:
- Burning, stabbing or tingling sensation/pain
- Numbness/paresthesia
- Cold, heat or pressure
- Hyperalgesia or allodynia
- Hypoesthesia
- Increased or decreased sharp sensation (e.g., pinprick testing)
- Decreased vibration/vibratory sensation
- (B): Prior diagnostic tests confirming lesion or disease explaining neuropathic pain (Nerve conduction studies, EMG, skin or nerve biopsy). Documentation of affected nerve(s) indicating that the subject's pain is of neuropathic origin and is a result of injury/trauma to the affected/implicated nerve(s).
Who cannot join
- Subjects presenting with ANY of the following will NOT be included in the study:
- Subjects with neuropathic pain due to:
- diabetic peripheral neuropathy
- post herpetic neuralgia
- Human Immunodeficiency Virus
- chemo/anti-viral therapy
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- trigeminal neuralgia
- carpal tunnel syndrome
- subjects whose post-traumatic neuropathic pain is categorized as central (e.g., spinal cord injury) rather than peripheral
- Subjects with pain due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)
- Phantom limb pain after amputation. However, subjects with stump pain and phantom sensation but no phantom pain will not be excluded
- Subjects with skin conditions in the affected dermatome that in the judgment of the investigator can interfere with evaluation of the neuropathic pain condition
- Subjects with other pain such as lumbar or cervical radiculopathy that may confound assessment or self-evaluation of the peripheral neuropathic pain
- subjects with significant somatic pain at the site of their trauma that may confound assessment or self-evaluation of their neuropathic pain
- Any subject considered at risk of suicide or self-harm based on investigator judgment and/or the details of a risk assessment
- Use of prohibited medications in the absence of appropriate washout periods
- Participation in any other clinical trial within the 30 days prior to screening and/or during participation in this study
- Subjects with a history of a cardiac arrhythmia that has led to the placement of a cardiac pacer or defibrillator will be excluded from the study
- Pregnant females and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception during the study
- Subjects with a current diagnosis of DSM-IV-TR Axis I disorder, including, for example:
- schizophrenia
- bipolar disorder
- other psychotic disorders such as schizoaffective disorder and delusion disorder
- somatoform disorders or factitious disorders
- bipolar disorders, even if controlled or stable
- alcohol or substance related disorders in the past 2 years
- however, diagnoses of Generalized Anxiety Disorder (GAD) or major depression (MDD) that is clinically stable are allowed
- Subjects with pending Worker's Compensation, Worker's Compensation, civil litigation or disability claims pertinent to the subject based upon trauma
- current involvement in out-of-court settlements for claims pertinent to subject's trauma
- subjects with fully resolved litigation and compensation claims can participate
- Subjects who have previously received either transcranial or transcutaneous magnetic stimulation therapy in the past
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: Improving Functions in Veterans With Post-Traumatic Peripheral Neuropathic Pain
The proposed study will set the foundation for future multi-center studies. To validate tMS as a non-contact and non-invasive pain treatment option for reducing pain in Veterans with PTP-NP and improving their overall functions.
Read the detailed description
This study will only be conducted at the VA hospital in San Diego.
- Conditions
- Neuropathic Pain
- Being tested
- Active Transcutaneous Magnetic Stimulation, Sham Transcutaneous Magnetic Stimulation
- Keywords
- neuropathic pain, TMS, nerve injury, transcutaneous magnetic stimulation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcutaneous Magnetic StimulationDevice
Also called TMS
Active transcutaneous magnetic stimulation (TMS) at the target site of nerve damage/injury.
Sham Transcutaneous Magnetic StimulationDevice
Also called TMS
Sham TMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
| Study group | Role | What they receive |
|---|---|---|
| Active transcutaneous magnetic stimulation | Experimental | Active transcutaneous magnetic stimulation (TMS) at the target site of nerve damage/injury. Receives: Device: Active Transcutaneous Magnetic Stimulation |
| Sham transcutaneous magnetic stimulation | Sham comparator | Sham TMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. Receives: Device: Sham Transcutaneous Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Spontaneous Pain Scores
Spontaneous pain rating: Spontaneous pain level will be measured by using a sliding algometer, known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable." The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents "no pain sensation" and 100 represents "the most intense pain sensation imaginable." A lower value indicates a better outcome with lower levels of pain reported.
Measured: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.
Secondary outcomes (2)
Evaluation of Evoked Pain Scores: Stroking
Stroking evoked pain will be assessed by gently moving a paintbrush over the site of PTNP. The patients will be asked if pain is felt. If so, the intensity of pain will be rated on a scale known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable." The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents "no pain sensation" and 100 represents "the most intense pain sensation imaginable." A lower value indicates a better outcome with lower levels of pain reported.
Measured: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.
Evaluation of Evoked Pain Scores: Von Frey
Punctate evoked pain will be conducted by gently pressing a 5.18 von Frey monofilament against the site of PTNP. The patients will be asked if pain is felt. If so, the intensity of pain will be rated on a scale known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable." The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents "no pain sensation" and 100 represents "the most intense pain sensation imaginable." A lower value indicates a better outcome with lower levels of pain reported.
Measured: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start1 Nov 2016
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Albert Yick Leung, MD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979925
- Sponsor's protocol ID
- B2366-P
- Other IDs
- 1192133
- Acronym
- PTP-NP
- Status last verified
- Jun 2021
- First submitted
- 29 Nov 2016
- Last updated
- 12 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Functions in Veterans With Post-Traumatic Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT02979925
- Acronym / sponsor ID
- PTP-NP / B2366-P
- Conditions
- Neuropathic Pain
- Keywords
- neuropathic pain, TMS, nerve injury, transcutaneous magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will set the foundation for future multi-center studies. To validate tMS as a non-contact and non-invasive pain treatment option for reducing pain in Veterans with PTP-NP and improving their overall functions.
Detailed description
This study will only be conducted at the VA hospital in San Diego.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active transcutaneous magnetic stimulation | Experimental | Device: Active Transcutaneous Magnetic StimulationActive transcutaneous magnetic stimulation (TMS) at the target site of nerve damage/injury. |
| Sham transcutaneous magnetic stimulation | Sham comparator | Device: Sham Transcutaneous Magnetic StimulationSham TMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- Subject is willing and able to comply with scheduled visits, treatment plan, daily pain, sleep and all study related assessments and procedures
- Subjects must be literate in the language used in the assessments and pain diary
- Veterans (men or women) of any race or ethnicity who are at least 18 years of age
- Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 7 days after the last session of the assigned treatment
Key exclusion criteria (31 listed)
- Subjects with neuropathic pain due to:
- Subjects with pain due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)
- Phantom limb pain after amputation. However, subjects with stump pain and phantom sensation but no phantom pain will not be excluded
- Subjects with skin conditions in the affected dermatome that in the judgment of the investigator can interfere with evaluation of the neuropathic pain condition
- Subjects with other pain such as lumbar or cervical radiculopathy that may confound assessment or self-evaluation of the peripheral neuropathic pain
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 |
|---|---|---|
| Active Transcutaneous Magnetic StimulationAlso: TMSActive transcutaneous magnetic stimulation (TMS) at the target site of nerve damage/injury. | Device | Active transcutaneous magnetic stimulation |
| Sham Transcutaneous Magnetic StimulationAlso: TMSSham TMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. | Device | Sham transcutaneous magnetic stimulation |
Primary outcome
Evaluation of Spontaneous Pain Scores
Time frame: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.
Spontaneous pain rating: Spontaneous pain level will be measured by using a sliding algometer, known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable." The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents "no pain sensation" and 100 represents "the most intense pain sensation imaginable." A lower value indicates a better outcome with lower levels of pain reported.
2 secondary outcomes
Evaluation of Evoked Pain Scores: Stroking
Time frame: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.
Evaluation of Evoked Pain Scores: Von Frey
Time frame: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Albert Yick Leung, MD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcutaneous Magnetic Stimulation in people with Neuropathic Pain, run by VA Office of Research and Development 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 29 inclusion and 31 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: finished, as of the sponsor's last update on 12 Jul 2021. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluation of Spontaneous Pain Scores (time frame: Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.). 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 Jul 2021.