PainNCT05628298
Pulsed Heat as a Drug-free Treatment for Pregnancy Related Pain
An observational study of Pain and Pain, Labor, run by Soovu Labs Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pain, Pain, Labor
- What is being tested?
- Soovu Pain Relief System
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2023to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Adult
Study population: Pregnant females in their 2nd and third trimester with pregnancy related pain
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical center
Seattle, Washington, 98101
Sheena Hembrador, MD, 206-223-6881, sheena.hembrador@vmfh.org
charles chabal, MD, 2065794910, ChabalMD@gmail.com
About this study
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.
Read more
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.
Read the detailed description
Pain associated with pregnancy occurs in approximately 60 to 70% of women. The mechanism of action of pulsed heat and TRPV-1 blockade is expected to be relevant in this population based on the etiology of their pain, and should help reduce their pain. In addition, there have been several pregnant women who have used the device to treat their pain associated with pregnancy. Their use was driven partly based on the FDA's recommendation to avoid non-steroidal anti-inflammatory medications limiting medication options. Based on these antidotal experiences and feedback, as well as the device's mechanism of action, this study is proposed.
The study is a pilot observational study that will provide results to support a larger more rigorous and involved clinical trial.
- The primary objective of this study is to determine whether the Soovu Pain Relief device is effective in reducing pain associated with pregnancy in the 2nd and 3rd trimester and in the first month postpartum.
- The secondary objectives include testing whether the study device reduces the effects of pain on physical function and the satisfaction and opinions of both subjects and providers on the effectiveness and usability of the study device. Subjects will also be asked about and needed pain medication use and their experience with the device if they used it during delivery.
Study design This is a single center nonrandomized non blinded pilot study on the effects of the Soovu Pain Relief device in pregnancy associated pain. 25-35 subjects are planned in the study which covers the 2nd and 3rd trimester and one month post-partum. Subjects will be referred to the study by their care providers or via posters in the clinic. Each subject who enters the study will receive a Soovu Pain Relief device with instructions on its use. All subjects will continue to receive their usual care. There are no visits associated with involvement in the study. Subjects can elect to use the device to treat their pain during the study and will record their pain level pre and post use. The data is collected via the phone app that controls the device. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
The total duration of the study is expected to be 14 months. 6-7 months for subject recruitment and 7 months for final subject follow-up.
The primary efficacy endpoint is the difference between the numerical pain score (0-10) pretreatment versus post treatment. Pain relief is the primary outcome measure as related to the study pain management device.
Secondary Efficacy Endpoints The secondary efficacy endpoints include whether the study device reduces the effects of pain on physical function and the satisfaction and opinions of both subjects and providers on the effectiveness and usability of the study device. The physical function questionnaire is a well validated instrument form the PROMIS outcome library and is a measure of function not necessarily pain. The usability and satisfaction evaluations help determine subject and provider acceptance of the device and can lead to product improvements.
The primary outcomes measure is pain level pre versus post treatment with the Soovu Device on a 0-10 point numeric scale. The data will be modeled as a repeated measures ordinal regression (primary choice), or a repeated measures model on a continuous response.
Analysis of Secondary Endpoints Changes on the PROMIS pain interference short form measure given on a monthly basis during the study will be analyzed using a Anova repeated measures technique.
Subject satisfaction with the experimental Soovu device at monthly intervals and one month post-partum if indicated (Likert scale) will be tabulated and represented as a mean value with standard deviations. Subjects will also be asked whether they needed any supplemental pain medications and the name or type of medications.
Provider assessment and opinions of device (Likert scale) at study conclusion and one month post-partum. The results will be tabulated and represented as a mean value with standard deviations.
- Conditions
- Pain, Pain, Labor
- Being tested
- Soovu Pain Relief System
- Keywords
- pain, pregnancy, Female
- Medical subject headings
- Pain, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soovu Pain Relief SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Soovu Pain Relief System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain level
Changes in pain level before and after treatment as measured by PROMIS NPR
Measured: After each treatment over a six month period
Secondary outcomes (1)
Changes in pain interference scale
- Changes on the PROMIS pain interference short form measure given on a monthly basis during the study.
Measured: Monthly over six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start15 Jan 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soovu Labs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Virginia Mason Hospital/Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628298
- Sponsor's protocol ID
- R23-22
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Heat as a Drug-free Treatment for Pregnancy Related Pain
- ClinicalTrials.gov ID
- NCT05628298
- Acronym / sponsor ID
- R23-22
- Conditions
- Pain, Pain, Labor
- Keywords
- pain, pregnancy, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Soovu Labs Inc.Industry (pharma, biotech, devices)
- Collaborators
- Virginia Mason Hospital/Medical Center
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pain associated with pregnancy occurs in approximately 60 to 70% of women. The mechanism of action of pulsed heat and TRPV-1 blockade is expected to be relevant in this population based on the etiology of their pain, and should help reduce their pain. In addition, there have been several pregnant women who have used the device to treat their pain associated with pregnancy. Their use was driven partly based on the FDA's recommendation to avoid non-steroidal anti-inflammatory medications limiting medication options. Based on these antidotal experiences and feedback, as well as the device's mechanism of action, this study is proposed.
The study is a pilot observational study that will provide results to support a larger more rigorous and involved clinical trial.
- The primary objective of this study is to determine whether the Soovu Pain Relief device is effective in reducing pain associated with pregnancy in the 2nd and 3rd trimester and in the first month postpartum.
- The secondary objectives include testing whether the study device reduces the effects of pain on physical function and the satisfaction and opinions of both subjects and providers on the effectiveness and usability of the study device. Subjects will also be asked about and needed pain medication use and their experience with the device if they used it during delivery.
Study design This is a single center nonrandomized non blinded pilot study on the effects of the Soovu Pain Relief device in pregnancy associated pain. 25-35 subjects are planned in the study which covers the 2nd and 3rd trimester and one month post-partum. Subjects will be referred to the study by their care providers or via posters in the clinic. Each subject who enters the study will receive a Soovu Pain Relief device with instructions on its use. All subjects will continue to receive their usual care. There are no visits associated with involvement in the study. Subjects can elect to use the device to treat their pain during the study and will record their pain level pre and post use. The data is collected via the phone app that controls the device. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
The total duration of the study is expected to be 14 months. 6-7 months for subject recruitment and 7 months for final subject follow-up.
The primary efficacy endpoint is the difference between the numerical pain score (0-10) pretreatment versus post treatment. Pain relief is the primary outcome measure as related to the study pain management device.
Secondary Efficacy Endpoints The secondary efficacy endpoints include whether the study device reduces the effects of pain on physical function and the satisfaction and opinions of both subjects and providers on the effectiveness and usability of the study device. The physical function questionnaire is a well validated instrument form the PROMIS outcome library and is a measure of function not necessarily pain. The usability and satisfaction evaluations help determine subject and provider acceptance of the device and can lead to product improvements.
The primary outcomes measure is pain level pre versus post treatment with the Soovu Device on a 0-10 point numeric scale. The data will be modeled as a repeated measures ordinal regression (primary choice), or a repeated measures model on a continuous response.
Analysis of Secondary Endpoints Changes on the PROMIS pain interference short form measure given on a monthly basis during the study will be analyzed using a Anova repeated measures technique.
Subject satisfaction with the experimental Soovu device at monthly intervals and one month post-partum if indicated (Likert scale) will be tabulated and represented as a mean value with standard deviations. Subjects will also be asked whether they needed any supplemental pain medications and the name or type of medications.
Provider assessment and opinions of device (Likert scale) at study conclusion and one month post-partum. The results will be tabulated and represented as a mean value with standard deviations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Device: Soovu Pain Relief SystemWomen 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant females in their 2nd and third trimester with pregnancy related pain
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soovu Pain Relief SystemThe 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. | Device | Experimental group |
Primary outcome
Changes in pain level
Time frame: After each treatment over a six month period
Changes in pain level before and after treatment as measured by PROMIS NPR
1 secondary outcome
Changes in pain interference scale
Time frame: Monthly over six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Pain, Labor, run by Soovu Labs Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact charles chabal, MD (2065794910, ChabalMD@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain level (time frame: After each treatment over a six month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.