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NCT05478265

Patient Observational Pain and Activity Survey (POPAS) Study Using RS-4i Sequential Stimulator With Intersperse Technology in Axial Spine and Peripheral Joint Pain

Completed Last updated 8 June 2025
What this trial tests

trial testing RS-4i Plus in Osteoarthritis in 69 participants. Completed in 30 June 2024.

Timeline
9 January 2023
Primary endpoint
30 June 2024
30 June 2024

Quick facts

Lead sponsorUniversity of California, Irvine
StatusCompleted
Study typeOBSERVATIONAL
Enrollment69
Start date9 January 2023
Primary completion30 June 2024
Estimated completion30 June 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Irvine

Who can join

Adults 18 to 89, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Osteoarthritis

Currently open trials in the same condition.

Other University of California, Irvine trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05478265.

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