RS-4i Sequential Stimulator with Intersperse Technology in Axial Spine and Peripheral Joint Pain

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

Details

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.

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Study Population:

Subjects will be current adult patients of the UCI PM&R or Orthopedic Department

Criteria:

Inclusion Criteria:

1. chronic and persistent MSK lumbar back pain for greater than 12 weeks as documented in 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 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