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Neuropathic Pain in Pregnancy

Neuropathic Pain in Pregnancy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02608463
Enrollment
15
Registered
2015-11-18
Start date
2016-01-01
Completion date
2019-04-19
Last updated
2021-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Pregnancy

Keywords

neuropathic pain, pregnancy

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.

Interventions

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.

BEHAVIORALPain 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.

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.

BEHAVIORALPatient'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.

DEVICETranscranial 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).

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Part A 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

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline Visual Analogue Scale for PainBaseline and end of study participation, an average of 194 days100 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Neuropathic Pain Group
≥13 on the painDETECT Questionnaire (PDQ)
10
Non-Neuropathic Pain Group
score of ≥1 or ≤12 on the PDQ
5
Controls
Patients without neuropathic pain receiving care as usual.
0
Total15

Baseline characteristics

CharacteristicTotalNeuropathic Pain GroupNon-Neuropathic Pain GroupControls
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
15 Participants10 Participants5 Participants0 Participants
Age, Continuous29.4 years29.4 years29.4 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants10 Participants5 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
14 Participants10 Participants4 Participants0 Participants
Region of Enrollment
United States
15 participants10 participants5 participants
Sex: Female, Male
Female
15 Participants10 Participants5 Participants0 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 50 / 0
other
Total, other adverse events
8 / 105 / 50 / 0
serious
Total, serious adverse events
3 / 103 / 50 / 0

Outcome results

Primary

Change From Baseline Visual Analogue Scale for Pain

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.

Time frame: Baseline and end of study participation, an average of 194 days

Population: No subjects were ever assigned to the control group, so no stats were performed on this group

ArmMeasureValue (LEAST_SQUARES_MEAN)
Neuropathic Pain GroupChange From Baseline Visual Analogue Scale for Pain-0.57 score on a scale
Non-Neuropathic Pain GroupChange From Baseline Visual Analogue Scale for Pain-14.4 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026