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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478265
• Other study ID #: 20216774
• Status: Recruiting
• Start date: January 9, 2023
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: David C Majors, MD
• Phone: 714-456-7720
• Email: dmajors1[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
United States	University of California at Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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