Neuropathic Pain in Pregnancy

Not Applicable

Completed

Conditions: Pain
Pregnancy

Interventions: Behavioral: painDETECT Questionnaire
Behavioral: Beck Depression Inventory
Behavioral: Pain Catastrophizing Scale
Behavioral: Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale
Device: Transcranial Magnetic Stimulation
Behavioral: Visual Analogue Scale
Behavioral: Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale

Registration Number: NCT02608463

Lead Sponsor: University of Arkansas

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 15

Inclusion Criteria

age 18-45 years old,
ability to give informed consent,
viable pregnancy, and
enrollment prior or equal to 24 weeks gestation

Exclusion Criteria

Active or history of substance use disorder within the past year
Non-English speaking

Part B

Inclusion Criteria:

Subjects enrolled in Part A and willing to consent to Part B of this protocol
Pregnant with current chronic neuropathic pain
Subjects failed treatment with amitriptyline or nortriptyline as defined by one of the following:
- no clinical improvement following a 4-week trial of amitriptyline or nortriptyline (i.e., CGI-I score ≥4)
- an inability to tolerate the medication (i.e., side effects)
Subjects must pass the TMS Safety Checklist Adult Safety Screen (TASS).
Subjects should be off medication, which can lower seizure thresholds (e.g., amitriptyline and nortriptyline) for at least two weeks prior to study entry.
Subjects with neuropathic pain including those with diagnosis of spinal cord injury, fibromyalgia, compression neuropathies (including diabetic peripheral neuropathy), post stroke pain, and multiple sclerosis
Subjects with a baseline VAS score greater than 30

Exclusion Criteria:

Current or past history of a seizure disorder (e.g., epilepsy)
Current history of preeclampsia
Current or history of brain lesions (e.g., aneurysm)
History of major head trauma (e.g., stroke; previous cranial neurosurgery)
Ferromagnetic metal in the head, neck, or chest (e.g., plates or pins, bullets, shrapnel)
Microprocessor implants in the head (e.g., cochlear implants) or life-sustaining microprocessor implants anywhere in the body (e.g., prosthetic cardiac valves)
Cardiac pacemaker
Active or inactive implants (e.g., deep brain stimulators, vagus nerve stimulators)
Active treatment with medications that lower seizure threshold (e.g., bupropion, amitriptyline, nortriptyline, or other TCA)
Increased intracranial pressure (which lowers seizure threshold)
Implanted medication pumps
Intracardiac lines
Significant heart disease defined as heart disease that causes moderate to severe symptoms and/or is characterized by moderate to severe pathology, including a recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional Classification of Class III or IV.
Bipolar disorder (to reduce the risk of mania)
History of suicide attempt(s)
Family history of epilepsy
Heavy alcohol consumption within the past 48 hours
Permanent makeup or tattoos with metallic dyes

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A - Neuropathic Pain	Pain Catastrophizing Scale	Subjects with a score of ≥ 13 on the painDETECT Questionnaire (PDQ) will be assigned to the Neuropathic Pain group.
Part A - Non-Neuropathic Pain	Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale	Subjects with a score of ≥ 1 or ≤ 12 on the painDETECT Questionnaire (PDQ) will be assigned to the Non-Neuropathic Pain group.
Part A - Neuropathic Pain	painDETECT Questionnaire	Subjects with a score of ≥ 13 on the painDETECT Questionnaire (PDQ) will be assigned to the Neuropathic Pain group.
Part A - Non-Neuropathic Pain	painDETECT Questionnaire	Subjects with a score of ≥ 1 or ≤ 12 on the painDETECT Questionnaire (PDQ) will be assigned to the Non-Neuropathic Pain group.
Part A - Control	painDETECT Questionnaire	Subjects with a score of score = 0 on the painDETECT Questionnaire (PDQ) will be assigned to the Control group.
Part B - rTMS	Beck Depression Inventory	Subjects from the Neuropathic Pain group will be invited to participate in the Part B rTMS group to receive repetitive transcranial magnetic stimulation (rTMS).
Part A - Neuropathic Pain	Visual Analogue Scale	Subjects with a score of ≥ 13 on the painDETECT Questionnaire (PDQ) will be assigned to the Neuropathic Pain group.
Part A - Non-Neuropathic Pain	Beck Depression Inventory	Subjects with a score of ≥ 1 or ≤ 12 on the painDETECT Questionnaire (PDQ) will be assigned to the Non-Neuropathic Pain group.
Part A - Control	Beck Depression Inventory	Subjects with a score of score = 0 on the painDETECT Questionnaire (PDQ) will be assigned to the Control group.
Part B - rTMS	Visual Analogue Scale	Subjects from the Neuropathic Pain group will be invited to participate in the Part B rTMS group to receive repetitive transcranial magnetic stimulation (rTMS).
Part A - Neuropathic Pain	Beck Depression Inventory	Subjects with a score of ≥ 13 on the painDETECT Questionnaire (PDQ) will be assigned to the Neuropathic Pain group.
Part A - Non-Neuropathic Pain	Visual Analogue Scale	Subjects with a score of ≥ 1 or ≤ 12 on the painDETECT Questionnaire (PDQ) will be assigned to the Non-Neuropathic Pain group.
Part A - Control	Visual Analogue Scale	Subjects with a score of score = 0 on the painDETECT Questionnaire (PDQ) will be assigned to the Control group.
Part A - Neuropathic Pain	Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale	Subjects with a score of ≥ 13 on the painDETECT Questionnaire (PDQ) will be assigned to the Neuropathic Pain group.
Part A - Neuropathic Pain	Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale	Subjects with a score of ≥ 13 on the painDETECT Questionnaire (PDQ) will be assigned to the Neuropathic Pain group.
Part A - Non-Neuropathic Pain	Pain Catastrophizing Scale	Subjects with a score of ≥ 1 or ≤ 12 on the painDETECT Questionnaire (PDQ) will be assigned to the Non-Neuropathic Pain group.
Part A - Non-Neuropathic Pain	Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale	Subjects with a score of ≥ 1 or ≤ 12 on the painDETECT Questionnaire (PDQ) will be assigned to the Non-Neuropathic Pain group.
Part A - Control	Pain Catastrophizing Scale	Subjects with a score of score = 0 on the painDETECT Questionnaire (PDQ) will be assigned to the Control group.
Part A - Control	Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale	Subjects with a score of score = 0 on the painDETECT Questionnaire (PDQ) will be assigned to the Control group.
Part A - Control	Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale	Subjects with a score of score = 0 on the painDETECT Questionnaire (PDQ) will be assigned to the Control group.
Part B - rTMS	Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale	Subjects from the Neuropathic Pain group will be invited to participate in the Part B rTMS group to receive repetitive transcranial magnetic stimulation (rTMS).
Part B - rTMS	Transcranial Magnetic Stimulation	Subjects from the Neuropathic Pain group will be invited to participate in the Part B rTMS group to receive repetitive transcranial magnetic stimulation (rTMS).

Primary Outcome Measures

Name	Time	Method
Change From Baseline Visual Analogue Scale for Pain	Baseline and end of study participation, an average of 194 days	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 total score ranges from 0-100 with higher numbers indicating worse outcomes. The VAS will be administered at every subject visit.

Secondary Outcome Measures