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

NCT05628298 | Unknown FDA Device

• 1 other identifier: R23-22
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Pain; Pain, Labor

Keywords

pain; pregnancy; Female

Outcome Measures

Primary Outcomes (1)

• Changes in pain level

  Changes in pain level before and after treatment as measured by PROMIS NPR

  After each treatment over a six month period

Secondary Outcomes (1)

• Changes in pain interference scale

  Monthly over six months

Study Arms (1)

Experimental group

Women in their 2nd and 3rd trimester of pregnancy who have significant pregnancy related pain (\>5/10). Subjects will be allowed to use the device during labor and one month postpartum.

Device: Soovu Pain Relief System

Interventions

Soovu Pain Relief System DEVICE

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Pregnant females
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant females in their 2nd and third trimester with pregnancy related pain

You may qualify if:

• Pregnant subjects in the second and third trimester of pregnancy with pain related to their pregnancy.
• Subjects must have a pain level greater then 4 on a 0-10 point numeric pain scale.
• Subjects between the ages of 18 and 60 years old.
• Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

You may not qualify if:

• Subjects felt to have any condition or complication related to their pregnancy that their provider recommends that the subject abstains from the use of the Soovu device.
• Subjects with a BMI \> 0.45
• Subjects who have a significant ongoing pain problem unrelated to their pregnancy that would make interpretation of their study data uncertain.
• Presence of a condition or abnormality that in the opinion of the investigator or provider would compromise the safety of the patient or the quality of the data.

Sponsors & Collaborators

• Soovu Labs Inc.: lead
• Virginia Mason Hospital/Medical Center: collaborator

Study Sites (1)

Virginia Mason Medical center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Pain; Labor Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

charles chabal, MD

CONTACT

2065794910; ChabalMD@gmail.com

Sheena hembrador, MD

CONTACT

888-825-3227; sheena.hembrador@vmfh.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: January 15, 2023
• Primary Completion: November 30, 2023
• Study Completion: March 30, 2024
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)