nCap Pain Relief Patch vs. Placebo
nCap Medical Nano-Capacitive Pain Relief Patch vs Placebo, a Prospective Randomized Controlled Trial
1 other identifier
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedStudy Start
First participant enrolled
April 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedApril 20, 2021
April 1, 2021
12 months
February 9, 2021
April 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain score using VAS scale
0-10 pain scale
After 30 minutes of use
Secondary Outcomes (4)
WOMAC score
3 weeks
Sustained pain response
3 weeks
Global assessment question
3 weeks
Pain medication monitoring
3 weeks
Study Arms (2)
Actual pain patch
EXPERIMENTALSham patch
PLACEBO COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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+)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- nCap Medicallead
Study Sites (1)
Knee Arthritis Clinical Trial Officew
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2021
First Posted
February 15, 2021
Study Start
April 16, 2021
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
April 20, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share