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Pulsed Heat as a Drug-free Treatment for Pregnancy Related Pain

NCT05628298 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2022-11-28

No results posted yet for this study

Summary

Studies indicate that up to 75% of women will experience pain sometime during their pregnancy. Recent recommendations by the FDA recommended that non-steroidal anti-inflammatory (NSAIDS) medications be avoided during pregnancy. This recommendation limits the pain medications available for use during pregnancy.

Antidotal evidence suggests that the FDA cleared Soovu pulsed heat device may produce pain relief during pregnancy. This study tests the Soovu device's ability to provide pain relief during pregnancy and up to one month post-partum and may eventually offer a safe nondrug option to treat pregnancy related pain.

This is an observational pilot study

The primary objective and hypothesis of this study is that the use of the Soovu pain management device will produce a significant reduction of pain when comparing pre versus post treatment pain.

Conditions

Interventions

DEVICE

Soovu Pain Relief System

The Soovu Pain Relief system uses pulses of heat to block the TRPV-1 calcium channel on peripheral pain nerves. The study will determine if the FDA cleared device significantly reduces the subject's pregnancy related pain.

Sponsors & Collaborators

  • Virginia Mason Hospital/Medical Center

    collaborator OTHER

  • Soovu Labs Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2023-11-30
Completion
2024-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05628298 on ClinicalTrials.gov