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NCT04109703 · ClinicalTrials.gov registry record · NA
High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
A NA study of Chronic Pain and Low Back Pain, sponsored by Soovu Labs.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04109703: Completed NA study of Chronic Pain and Low Back Pain, sponsored by Soovu Labs.
NCT04109703 is a NA study of Chronic Pain and Low Back Pain that has completed, run by Soovu Labs. The registered enrollment target is 100 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04109703, a NA study of Chronic Pain and Low Back Pain, has completed, sponsored by Soovu Labs.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a double blinded randomized active placebo controlled trial in subjects with chronic low back pain. The trial compares pain relief by a device that delivered high level pulsed heat (45 °C) to pain relief delivered by a steady heat lower temperature device (37 °C). The hypothesis is that the high temperature pulsed heat device will produce significantly better pain relief as compared to the lower level steady heat device. The secondary hypothesis is that pain relief will occur faster in the high pulsed heat device as compared to the control device.
Primary Outcome
Numerical Pain Score (NPS) Range Zero (minimum) through ten (maximum score) thirty minutes after completion of the treatment session.
Conditions Studied
Interventions
- DEVICE High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.
- DEVICE Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.
Study Locations (1)
California
- Northern California Research Institute - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2019-09-25 |
| Phase | NA |
What the finished NCT04109703 record still lists
NCT04109703 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (87% lower).
The record links to 4 conditions, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions - of which High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc. is the first listed.
NCT04109703 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04109703 about?
NCT04109703 is a clinical study titled "High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain". This study is a double blinded randomized active placebo controlled trial in subjects with chronic low back pain. The trial compares pain relief by a device that delivered high level pulsed heat (45 °C) to pain relief delivered by a steady heat lower temperature device (37 °C). The hypothesis is tha...
What is the current status of trial NCT04109703?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2019-06-01. Estimated completion is 2019-09-25.
What conditions does trial NCT04109703 study?
This clinical trial studies the following conditions: Chronic Pain, Low Back Pain, Analgesia, Heat.
What interventions are being tested in trial NCT04109703?
The interventions under investigation include: High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc. (DEVICE), Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc. (DEVICE).
Who is sponsoring clinical trial NCT04109703?
This trial is sponsored by Soovu Labs, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04109703 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04109703's enrollment target sits among peer trials
100 132nd of 301 higher than 164 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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