nCap Pain Relief Patch vs. Placebo

Osteoarthritis, Knee Clinical Trial

Official title:

nCap Medical Nano-Capacitive Pain Relief Patch vs Placebo, a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753567
• Other study ID #: 00127554
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2021
• Est. completion date: April 2022

Study information

• Verified date: April 2021
• Source: nCap Medical
• Contact: Tatjana Warren, PhD CRNA
• Phone: 8584051003
• Email: tsbevans[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether use of the nCap Medical Nano-Capacitive pain relief patch reduces subject pain as measured by subject pain scores, WOMAC scores (pain, stiffness and physical function), global assessment scores, and pain medication change as compared to participants randomly assigned to the sham patch group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

Inclusion Criteria:

• Meet Altman's clinical criteria for Knee Osteoarthritis

• Male and Female Adults age 40-79

• VAS pain score of > 4 at the beginning of the study

Exclusion Criteria:

• Subject unable to walk unassisted. Participants must be able to stand/walk for 30 minutes

• Inability to read and understand English. Must be able to complete WOMAC scale and questionnaires

• Severe systemic disease limiting ability to ambulate for 30 minutes

• Use of a TENS unit for one week before study or during study

• History of total knee replacement on the affected knee

• Knee surgery on the affected knee in the last 12 months

• Injection into the knee in the last 6 months

• Knee pain < 411

• Inability to cognitively understand consent form or research study, or inability to give consent

• Diagnosis of fibromyalgia, rheumatoid arthritis, gout, dysplasia, septic arthritis, knee pain from other diseases.

• Malignancy

• Injury to knee within 6 months

• Concomitant use of opioids, NSAIDS or other analgesics for 1 week before trial (or 5 half-lives, whichever is greater)9, or during trial with exception of acetaminophen.

• Pregnant or lactating

• Poor general health (ASA classification of IV+)

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• nCap pain relief patch
Each participant will be randomly assigned to sham or actual patch. Patches will be worn for 3 weeks. Pain and quality of life will be assessed and compared between groups
• Sham Patch
Sham patch will be worn for 3 weeks exactly like actual pain patch

Locations

Country	Name	City	State
United States	Knee Arthritis Clinical Trial Officew	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
nCap Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score using VAS scale	0-10 pain scale	After 30 minutes of use
Secondary	WOMAC score	arthritis assessment score	3 weeks
Secondary	Sustained pain response	0-10 VAS pain score	3 weeks
Secondary	Global assessment question	How the patient feels they are doing	3 weeks
Secondary	Pain medication monitoring	Tylenol use	3 weeks