Neuropathic Pain in Pregnancy
Condition: Pain; Pregnancy
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      This will be the first study to investigate the use of rTMS in the treatment of neuropathic
      pain in pregnancy. This study will enroll 60 pregnant subjects, age 18-45. All participants
      will receive treatment as usual. Subjects diagnosed with neuropathic pain will be offered
      rTMS as a treatment option.
    

Detailed description: 
      Neuropathic pain is a common pain disorder that is caused by problems in the nervous system.
      It affects more women than men and commonly occurs in pregnancy. Physicians have little
      information to guide their treatment of neuropathic pain in pregnancy. The overall goal of
      this study is to define the course, management, and pregnancy outcomes of neuropathic pain in
      pregnancy and the acute postpartum period. It is difficult to manage neuropathic pain in
      pregnancy as treatment options must minimize their risk to the unborn child as they have a
      direct effect on infant outcomes through their exposure in utero. Thus, other treatments are
      needed. Repetitive transcranial magnetic stimulation (rTMS) may be an acceptable alternative
      to medications. Transcranial magnetic stimulation uses a magnetic force to change the way
      nerves work in the brain. This non-invasive and localized mechanism of action makes it
      attractive for use in special populations, such as pregnancy. Study visits will occur
      approximately every 4-6 weeks during pregnancy until approximately 3 months postpartum for a
      maximum of 12 visits.
    

Intervention name(s): painDETECT Questionnaire; Pain Catastrophizing Scale; Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale; Beck Depression Inventory; Visual Analogue Scale; Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale; Transcranial Magnetic Stimulation
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Device
Intervention description(s): This self-report questionnaire consists of 7 questions that address the quality of neuropathic pain syndromes. The first 5 questions ask about the gradation of pain, question 6 asks about the pain course pattern and question 7 asks about radiating pain. There are 4 additional questions (not counted in the total score) which asks the subject to rate their pain now and over the last 4 weeks and to mark on a body chart if there is pain radiating into other parts of the body.; The PCS is a 13-item self-report scale. It asks subjects to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification, and helplessness.; The 3-item, self-report Pain Intensity assesses how much a person hurts. The first 2 items assess pain intensity over the past 7 days; the last item asks subject to rate pain intensity "right now." The 4-item, self-report Pain Interference measures the consequences of pain on relevant aspects of subject's life. It includes impairment in subject's social, cognitive, emotional, physical, & recreational activities. It also incorporates items about sleep and enjoyment of life. It assesses pain interference over the past 7 days.
The 7-item, self-report Pain Behavior measures behaviors that typically indicate to others that an individual is experiencing pain. Measures include observations (sighing, crying), behaviors (resting, guarding, facial expressions, asking for help), & verbal reports of pain. It assesses pain interference over the past 7 days.
All three scales, derived from the Patient Reported Outcomes Measurement Information System (PROMIS), are not disease specific.; The BDI is a widely used instrument that has been used in both clinical and non-clinical setting measuring depressive symptoms. It is a 21 item questionnaire with 4-5 responses for each question. Responses are coded 0-3 for the 4 point scales. The 5 point scales include an additional 2a and 2b response code. The symptom categories reflect overt behavioral manifestations of depression. The instrument has both a high degree of reliability and validity (Beck, Ward, Mendelson, Mock & Erbaugh, 1961).; 100 mm line scale that is subject administered to subjectively rate current pain symptoms. The subject will be instructed to draw a single vertical line that best describes current state.; The PGIC gives a global rating of change in symptoms, activities, emotion, and overall quality of life related to the subject's pain condition. This is a self-rated scale.
The CGI-I gives a global rating of the improvement/change in the symptoms since the last study visit. This is administered by the MD.; Subjects will undergo daily repetitive transcranial magnetic stimulation (rTMS), defined as Monday through Friday, for a total of 10 consecutive sessions. rTMS will be applied using the NeuroStar TMS Therapy System through a figure-8 coil connected to a magnetic stimulator, which provides a biphasic pulse. The coil is applied to the primary motor cortex, M1, contralateral to the painful side. The optimal stimulus site, motor hot spot, will be determined according to visual detection of muscle twitches, and a resting motor threshold is defined as the minimal intensity necessary to induce at least one visible muscle twitch. An rTMS session consists of 10 trains at 90% intensity of resting motor threshold (one train, 100 pulses at 10 Hz; intertrain interval, 50s).
Other intervention name(s): PDQ; PCS; Pain Measures; BDI; VAS; PGIC & CGI-I; NeuroStar® TMS
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects will participate in Part A, receive standard of care and complete the painDETECT Questionnaire (PDQ) to be assigned to 1 of 3 groups based on the PDQ score.
Subjects in Part A will complete the following at study entry and each study visit: the Beck Depression Inventory (BDI), Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), and measures of pain intensity, interference, behavior. At each visit after study entry, subjects will complete the Patients' Global Impression of Change scale (PGIC); clinicians will complete the Clinical Global Impression-Global Improvement scale (CGI-I).
Subjects in Part B will receive rTMS and be followed daily until day 29 after last rTMS session. For each session, subjects will complete a VAS prior, immediately after, and 60 minutes post, day 22 & day 29; a BDI on Days 1, 5, 12, 22, & 29; on days 5, 12, 22, & 29 subjects will complete the PGIC; clinicians will complete the CGI-I.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: neuropathic pain; pregnancy