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NCT05478265 · ClinicalTrials.gov registry record
Patient Observational Pain and Activity Survey (POPAS) Study Using RS-4i Sequential Stimulator With Intersperse Technology in Axial Spine and Peripheral Joint Pain
A clinical trial, sponsored by University of California, Irvine.
- Completed
- Registry status
- 69
- Enrollment target
NCT05478265 is a clinical trial that has completed, run by University of California, Irvine. The registered enrollment target is 69 participants.
The verdict
NCT05478265 has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- 69 participants
- Enrollment target
Study Summary
Spine pain and joint pain are among the most common worldwide ailments and directly contributes to disability as well as increased duration of care. Spine and joint pain affect work sick leave, production and increased financial costs to healthcare. Non-invasive treatments for spine and joint pain can vary widely from lifestyle changes, physical therapy, oral medication, and select medical devices, that can improve pain level and help improve the quality of life of individuals. Thus, the general population suffers from an ailment that has multiple conservative treatment options with variable outcomes. Transcutaneous Electrical Neuromuscular Stimulation (TENS) has been show to decrease pain and restore function. Interferential therapy (INF) is a specific signal type that is effective for reducing musculoskeletal pain. Neuromuscular Electrical Stimulation (NMES) uses a specific signal type to cause muscles to contract and therefore provide functional improvement. The RS-4i Plus is an FDA-regulated prescription TENS medical device that outputs an INF signal and a NMES signal, and a unique Intersperse signal, which combines NMES and INF into a single treatment. Therefore, the goal of this study is to determine if use of the prescribed RS-4i Plus in patients presenting with pain, axial or peripheral joint, can be efficacious in decreasing the patient's pain and improving their activity measured at one month, three months, and six months of use.
Interventions
- DEVICE RS-4i Plus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2024-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05478265
The ClinicalTrials.gov registry entry for NCT05478265 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RS-4i Plus is the first listed.
NCT05478265 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05478265 about?
NCT05478265 is a clinical study titled "Patient Observational Pain and Activity Survey (POPAS) Study Using RS-4i Sequential Stimulator With Intersperse Technology in Axial Spine and Peripheral Joint Pain". Spine pain and joint pain are among the most common worldwide ailments and directly contributes to disability as well as increased duration of care. Spine and joint pain affect work sick leave, production and increased financial costs to healthcare. Non-invasive treatments for spine and joint pain c...
What is the current status of trial NCT05478265?
This trial is currently completed. The enrollment target is 69 participants. The study started on 2023-01-09. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT05478265?
The interventions under investigation include: RS-4i Plus (DEVICE).
Who is sponsoring clinical trial NCT05478265?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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