CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
painDETECT Questionnaire +6 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02608463
NCT02608463N/ACompleted

Neuropathic Pain in Pregnancy

University of Arkansas·interventional·Posted Nov 18, 2015·Updated Jun 23, 2021

In Brief

A clinical study evaluating painDETECT Questionnaire, Pain Catastrophizing Scale, and 5 other interventions for Pain and Pregnancy. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Pregnancy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 18, 2015
Enrollment StartJan 1, 2016
Primary CompletionApr 19, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.6 years ago

Interventions

painDETECT Questionnairebehavioral

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.

Pain Catastrophizing Scalebehavioral

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.

Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scalebehavioral

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.

Beck Depression Inventorybehavioral

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).

Visual Analogue Scalebehavioral

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.

Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scalebehavioral

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.

Transcranial Magnetic Stimulationdevice

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).