NCT02608463

Neuropathic Pain in Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Pregnancy

Interventions

Type	Name	Description
BEHAVIORAL	painDETECT Questionnaire	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.
BEHAVIORAL	Pain Catastrophizing Scale	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.
BEHAVIORAL	Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale	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.
BEHAVIORAL	Beck Depression Inventory	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).
BEHAVIORAL	Visual Analogue Scale	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.
BEHAVIORAL	Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale	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.
DEVICE	Transcranial Magnetic Stimulation	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).

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-04-19
• Completion: 2019-04-19
• First posted: 2015-11-18
• Last updated: 2021-06-23
• Results posted: 2020-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study