AtMS for Alleviating Posttraumatic Peripheral Neuropathic Pain (PTP-NP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Functionality - Absenteeism
研究概览
简要总结
The goal of this clinical trial is to learn if adaptative transcutaneous magnetic stimulation (AtMS) works to reduce pain caused by post-traumatic peripheral neuropathic pain (PTP-NP) within Veterans and/or active duty military personnel. It will also learn about the safety of AtMS. The main questions it aims to answer are:
- What are the effects of adaptative tMS (AtMS) in alleviating patients' PTP-NP compared to fixed tMS (FtMS) and Sham-tMS?
- What are the effects of AtMS in improving functions in patients suffering from PTP-NP compared to FtMS and Sham-tMS?
- What are the effects of AtMS in improving mood in patients suffering from PTP NP compared FtMS and Sham-tMS?
Researchers will compare AtMS, FtMS and Sham-tMS to see if AtMS is the best form of tMS in treating PTP-NP.
Participants will undergo the following:
- Receive a total of 8 AtMS, FtMS, or Sham-tMS treatments over 16 weeks.
- Visit the clinic a total of 12 times for assessments, check ups, and treatments.
- Keep a daily diary of their PTP-NP intensity, sleep interference, and pain medications used.
详细描述
This study will be enrolling a total of 144 veterans or active military over a 4 year period at the VA San Diego Healthcare System (VASDHS). Participants will be randomized into one of three groups:
Group A: AtMS Group B: FtMS Group C: Sham-tMS
Individual participation will consist of 12 visits to the VASDHS over the course of 5 months. The visits will be divided into the following phases:
- PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments)
- INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-7 (5 weekday tMS sessions at >24 and <72 hours apart); and
- POST-TREATMENT ASSESSMENTS AND MAINTENANCE TREATMENT PHASE (weeks 6-20) consists of 2 initial biweekly post-induction treatment assessments and maintenance treatments (Visits 8 and 9), and two additional monthly post-induction treatment assessments and maintenance treatments (Visits 10 and 11) and one final study visit (Visit 12)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans (men or women) of any race or ethnicity who are at least 18 years of age
- •Chronic peripheral neuropathic pain present for more than 4 months after a traumatic or surgical event per medical history
- •Have an average daily Numerical Pain Rating Scale (NPRS) score > 3
- •At least one negative or positive sensory sign or symptom confined to innervation territory of the lesioned nervous structure
- •Prior diagnostic tests confirming lesion or disease explaining neuropathic
排除标准
- •Pregnancy
- •Subjects with central neuropathic pain (ex: due to diabetic peripheral neuropathy, HIV, chemo/anti-viral therapy, carpal tunnel syndrome, post-traumatic pain classified as central rather than peripheral)
- •Subjects with pain due to Complex Regional Pain Syndrome
- •Phantom limb pain after amputation (stump pain and phantom sensation are allowed)
- •Subjects with skin conditions in the affected dermatome
- •Subjects with other pain such as lumbar or cervical radiculopathy that may confound assessment
- •Any subject considered at risk of suicide
- •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
- •Heart pacemaker
- •Subjects with a current diagnosis of DSM-IV-TR Axis I disorder (GAD & MDD are allowed if clinically stable)
- •Subjects with pending lawsuits related to injury
- •Subjects who have previously received either transcranial or transcutaneous magnetic stimulation therapy in the past
结局指标
主要结局
Functionality - Absenteeism
时间窗: From baseline to the end of treatment at 20 weeks
Work Productivity and Activity Impairment Questionnaire (WPAI-SHP version 2) metric 1: Absenteeism (the percentage of work time missed); \*\*\*Only those being employed provided answer for absenteeism\*\*\* WPAI absenteeism scores are based 2-items (2 and 4); a score cannot be calculated if there is a missing response to the corresponding item. Question 2 represents time in hours lost due to health reasons while question 4 represents the time spent working. Time lost is divided by the total time (sum of 2 and 4) and then multiplied by 100 to express as a percentage. All WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
Functionality - Presenteeism
时间窗: From baseline to the end of treatment at 20 weeks
Work Productivity and Activity Impairment Questionnaire (WPAI-SHP version 2) metric 2: Presenteeism (the percentage of impairment experienced while at work); \*\*\*Only those being employed provided answer for presenteeism\*\*\* WPAI presenteeism scores are based on 1-item (5) which is divided by 10 and later multiplied by 100 to express as a percentage; a score cannot be calculated if there is a missing response to the corresponding item. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
Functionality - Overall work Productivity Impairment
时间窗: From baseline to the end of treatment at 20 weeks
Work Productivity and Activity Impairment Questionnaire (WPAI-SHP version 2) metric 3: Overall work productivity loss (an estimate of combination of absenteeism and presenteeism); \*\*\*Only those being employed provided answer for absenteeism {Q2/(Q2+Q4)}, presenteeism {Q5/10}\*\*\* WPAI overall work productivity scores are computed based on absenteeism and presenteeism scores, using the following formula, Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4)))x(Q5/10)\], and then being multiplied by 100 to express as a percentage; a score cannot be calculated if there is a missing response to the corresponding item. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
Functionality - Activity Impairment
时间窗: From baseline to the end of treatment at 20 weeks
Work Productivity and Activity Impairment Questionnaire (WPAI-SHP version 2) metric 4: Activity impairment (the percentage of impairment in daily activities) \*\*\*Only those being employed provided answer for absenteeism, presenteeism, and overall work impairment\*\*\* WPAI activity impairment scores are based on 1-item (item 6) which is divided by 10 and later multiplied by 100 to express as a percentage; a score cannot be calculated if there is a missing response to the corresponding item. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
Neuropathic Pain Rating
时间窗: From enrollment to the end of treatment at 20 weeks
0 is equivalent to no neuropathic pain and 10 indicates the worst possible neuropathic pain
Mood
时间窗: From baseline to the end of treatment at 20 weeks
Hamilton Rating Scale for Depression (HRSD) an interviewed asks 21 questions about mood, sleep, appetite, and other symptoms related to depression. The interviewer rates the severity of each symptom based on a pre-defined scale of 0-4. The scores for each item are then summed to produce a total score. The total score on the HAM-D is used to assess the severity of depression. Lower scores indicate less severe depression, while higher scores indicate more severe depression. Typical scoring interpretations: Below 7: Absence or remission of depression; 7-17: Mild depression; 18-24: Moderate depression; 25 and above: Severe depression
Quality of Life (Sleep Interference)
时间窗: From enrollment to the end of treatment at 20 weeks
Daily Sleep Interference Log measures how much neuropathic pain impacts the patients sleep each night. The log is ranked on a 0 to 10 scale, 0 being pain didn't interfere with sleep and 10 being pain completely interfered with sleep, with a lower score representing a better outcome.
次要结局
- QST Temperature Thresholds(From baseline to end of treatment at 20 weeks)
- von Frey Monofilament Threshold(From baseline to end of the treatment at 20 weeks)
- Neuropathic Pain Medication Usage(From enrollment to the end of treatment at 20 weeks)
- Allodynia Area Mapping (Von Frey)(From baseline to the end of treatment at 20 weeks)
- Allodynia Area Mapping (paint brush)(From baseline to the end of treatment at 20 weeks)