OsteoarthritisNCT05478265
Patient Observational Pain and Activity Survey (POPAS) Study Using RS-4i Sequential Stimulator With Intersperse Technology in Axial Spine and Peripheral Joint Pain
An observational study of Osteoarthritis, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- RS-4i Plus
- Type of treatment
- Medical device
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be current adult patients of the UCI PM\&R or Orthopedic Department
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Irvine Medical Center
Orange, California, 92868
About this study
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.
- Conditions
- Osteoarthritis
- Being tested
- RS-4i Plus
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS-4i PlusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Axial Spine only, Age 65+ | Not described Receives: Device: RS-4i Plus | |
| Axial Spine only, Age 18-64 | Not described Receives: Device: RS-4i Plus | |
| Peripheral Joint only, Age 65+ | Not described Receives: Device: RS-4i Plus | |
| Peripheral Joint only, Age 18-64 | Not described Receives: Device: RS-4i Plus | |
| Axial + Peripheral Joint, Age 65+ | Not described Receives: Device: RS-4i Plus | |
| Axial + Peripheral Joint, Age 18-64 | Not described Receives: Device: RS-4i Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start9 Jan 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Majors, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478265
- Sponsor's protocol ID
- 20216774
- Status last verified
- Jun 2025
- First submitted
- 25 Jul 2022
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05478265
- Acronym / sponsor ID
- 20216774
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Axial Spine only, Age 65+ | – | Device: RS-4i Plus |
| Axial Spine only, Age 18-64 | – | Device: RS-4i Plus |
| Peripheral Joint only, Age 65+ | – | Device: RS-4i Plus |
| Peripheral Joint only, Age 18-64 | – | Device: RS-4i Plus |
| Axial + Peripheral Joint, Age 65+ | – | Device: RS-4i Plus |
| Axial + Peripheral Joint, Age 18-64 | – | Device: RS-4i Plus |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be current adult patients of the UCI PM\&R or Orthopedic Department
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RS-4i PlusRS-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. | Device | Axial + Peripheral Joint, Age 18-64, Axial + Peripheral Joint, Age 65+, Axial Spine only, Age 18-64, Axial Spine only, Age 65+, Peripheral Joint only, Age 18-64, Peripheral Joint only, Age 65+ |
Primary outcome
Level of Pain / Function using NRS
Time frame: 1 month
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
Level of Pain / Function using NRS
Time frame: 3 month
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
Level of Pain / Function using NRS
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Pain / Function using NRS (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.