nCap Pain Relief Patch vs. Placebo

April 16, 2021 updated by: nCap Medical

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • Knee Arthritis Clinical Trial Officew
        • Contact:
          • Tatjana Warren, PhD
          • Phone Number: 801-970-2577

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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+)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Actual pain patch
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
PLACEBO_COMPARATOR: Sham patch
Device: Sham Patch
Sham patch will be worn for 3 weeks exactly like actual pain patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score using VAS scale
Time Frame: After 30 minutes of use
0-10 pain scale
After 30 minutes of use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC score
Time Frame: 3 weeks
arthritis assessment score
3 weeks
Sustained pain response
Time Frame: 3 weeks
0-10 VAS pain score
3 weeks
Global assessment question
Time Frame: 3 weeks
How the patient feels they are doing
3 weeks
Pain medication monitoring
Time Frame: 3 weeks
Tylenol use
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

nCap Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 16, 2021

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (ACTUAL)

February 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00127554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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