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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: RS-4i Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic and persistent MSK lumbar back pain for greater than 12 weeks as documented in patient records Age 18 to 89 Willingness to comply with study protocol Signed Patient Consent on file Verified patient usage collected from RS-4i Plus via patient data adapter Exclusion Criteria: Pregnancy Any contraindications, as indicated in the RS-4i Plus prescribing information Substantial allergy to adhesives Skin infection or irritation of skin where electrodes are to be placed Pacemaker/ICD Abnormal skin sensation Serious psychological disorder End-stage cardiac, peripheral arterial or pulmonary disease h/o recent vertebral fracture Severe degenerative or traumatic neuromuscular disease Non-English speaking Uncontrolled diabetes meelitus (Hb A1c> 8.5%) ESRD or ESHD Active cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Axial Spine only, Age 65+<br> | Device: RS-4i Plus<br>* 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.<br>|
| Axial Spine only, Age 18-64<br> | Device: RS-4i Plus<br>* 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.<br>|
| Peripheral Joint only, Age 65+<br> | Device: RS-4i Plus<br>* 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.<br>|
| Peripheral Joint only, Age 18-64<br> | Device: RS-4i Plus<br>* 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.<br>|
| Axial + Peripheral Joint, Age 65+<br> | Device: RS-4i Plus<br>* 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.<br>|
| Axial + Peripheral Joint, Age 18-64<br> | Device: RS-4i Plus<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 6 months |