Improving Functions in Veterans With Post-traumatic Peripheral Neuropathic Pain

Completed · Not applicable · Has a placebo group

Conditions studied: Neuropathic Pain

In brief

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.

Key facts

Study ID

NCT02979925

Run by

VA Office of Research and Development

People needed

57

Starts

2016-11-01

Expected to finish

2019-09-30

Last updated by the study team

2021-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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

Where it is running

• VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States

Full record on ClinicalTrials.gov

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