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

Last updated: June 6, 2025
Sponsor: University of California, Irvine
Overall Status: Completed

Phase

N/A

Condition

Osteoarthritis

Muscle Pain

Arthritis And Arthritic Pain

Treatment

RS-4i Plus

Clinical Study ID

NCT05478265
20216774
  • Ages 18-89
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. chronic and persistent MSK lumbar back pain for greater than 12 weeks as documentedin patient records

  2. Age 18 to 89

  3. Willingness to comply with study protocol

  4. Signed Patient Consent on file

  5. Verified patient usage collected from RS-4i Plus via patient data adapter

Exclusion

Exclusion Criteria:

  1. Pregnancy

  2. Any contraindications, as indicated in the RS-4i Plus prescribing information

  3. Substantial allergy to adhesives

  4. Skin infection or irritation of skin where electrodes are to be placed

  5. Pacemaker/ICD

  6. Abnormal skin sensation

  7. Serious psychological disorder

  8. End-stage cardiac, peripheral arterial or pulmonary disease

  9. h/o recent vertebral fracture

  10. Severe degenerative or traumatic neuromuscular disease

  11. Non-English speaking

  12. Uncontrolled diabetes meelitus (Hb A1c> 8.5%)

  13. ESRD or ESHD

  14. Active cancer

Study Design

Total Participants: 69
Treatment Group(s): 1
Primary Treatment: RS-4i Plus
Phase:
Study Start date:
January 09, 2023
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • University of California at Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

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