An observational study in Osteoarthritis, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by University of California, Irvine · Observational
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.
273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.
This study's enrollment of 69 is below the median of 120 across 44 observational studies indexed under Arthralgia.
Browse Arthralgia studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be current adult patients of the UCI PM\&R or Orthopedic Department
Exclusion Criteria:
Device: RS-4i Plus
Device: RS-4i Plus
Device: RS-4i Plus
Device: RS-4i Plus
Device: RS-4i Plus
Device: RS-4i Plus
RS-4i Plus in an FDA-regulated prescription TENS medical device that outputs and INF signal and a NMES signal and Intersperse signal, which combines INF and NMES into a single treatment.
Level of Pain / Function using NRS
Outcome with be rated on a scale of 0-10, in which 10 is the most severe pain / worst function and 0 is the least pain / best function. The time frame will include assessment at 1 month interval to determine if the intervention is showing a change / long term improvement in the pain / function
Time frame: 1 month
Level of Pain / Function using NRS
Outcome with be rated on a scale of 0-10, in which 10 is the most severe pain / worst function and 0 is the least pain / best function. The time frame will include assessment at 3 month interval to determine if the intervention is showing a change / long term improvement in the pain / function
Time frame: 3 month
Level of Pain / Function using NRS
Outcome with be rated on a scale of 0-10, in which 10 is the most severe pain / worst function and 0 is the least pain / best function. The time frame will include assessment at 6 month interval to determine if the intervention is showing a change or long term improvement in the pain / function
Time frame: 6 months
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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University of California, Irvine