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

Osteoarthritis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05478265
Study type Observational
Source University of California, Irvine
Contact David C Majors, MD
Phone 714-456-7720
Email dmajors1@hs.uci.edu
Status Recruiting
Phase
Start date January 9, 2023
Completion date August 2024
View Details
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