ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 58 for:    (complementary OR alternative) medicine AND (woman OR women OR female) | pain

Neuropathic Pain in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02608463
Recruitment Status : Active, not recruiting
First Posted : November 18, 2015
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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. 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 between the ages of 18 and 45. Participation in the study will last about 15 months with study visits about once a month. All participants will receive treatment as usual. Subjects diagnosed with neuropathic pain will be offered rTMS as a treatment option.

Condition or disease Intervention/treatment Phase
Pain Pregnancy Device: Transcranial Magnetic Stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Neuropathic Pain in Pregnancy
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Neuropathic Pain
Subjects will complete the painDETECT Questionnaire at study entry and be assigned to this group with a score ≥13. They will receive be invited to participate in repetitive transcranial magnetic stimulation (rTMS).
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).

No Intervention: Non-neuropathic Pain
Subjects will complete the painDETECT Questionnaire at study entry and be assigned to this group with a score on the 1≥score≤12 on the PDQ. They will receive no study intervention.
No Intervention: Control
Subjects will complete the painDETECT Questionnaire at study entry and be assigned to this group with a score = 0 on the PDQ. They will receive no study intervention.



Primary Outcome Measures :
  1. Change from Baseline Visual Analogue Scale for Pain [ Time Frame: Within approximately 40 weeks (pregnancy) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608463


Locations
United States, Arkansas
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Shona L Ray-Grififth, MD University of Arkansas

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02608463     History of Changes
Other Study ID Numbers: 204737
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Arkansas:
neuropathic pain
pregnancy

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms