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nCap Pain Relief Patch vs. Placebo

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nCap pain relief patch
Sham Patch
Sponsored by
nCap Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring pain, arthritis

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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+)

Sites / Locations

  • Knee Arthritis Clinical Trial OfficewRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Actual pain patch

Sham patch

Arm Description

Outcomes

Primary Outcome Measures

Pain score using VAS scale
0-10 pain scale

Secondary Outcome Measures

WOMAC score
arthritis assessment score
Sustained pain response
0-10 VAS pain score
Global assessment question
How the patient feels they are doing
Pain medication monitoring
Tylenol use

Full Information

First Posted
February 9, 2021
Last Updated
April 16, 2021
Sponsor
nCap Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04753567
Brief Title
nCap Pain Relief Patch vs. Placebo
Official Title
nCap Medical Nano-Capacitive Pain Relief Patch vs Placebo, a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
nCap Medical

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
pain, arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Actual pain patch
Arm Type
Experimental
Arm Title
Sham patch
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
nCap pain relief patch
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham Patch
Intervention Description
Sham patch will be worn for 3 weeks exactly like actual pain patch
Primary Outcome Measure Information:
Title
Pain score using VAS scale
Description
0-10 pain scale
Time Frame
After 30 minutes of use
Secondary Outcome Measure Information:
Title
WOMAC score
Description
arthritis assessment score
Time Frame
3 weeks
Title
Sustained pain response
Description
0-10 VAS pain score
Time Frame
3 weeks
Title
Global assessment question
Description
How the patient feels they are doing
Time Frame
3 weeks
Title
Pain medication monitoring
Description
Tylenol use
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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+)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatjana Warren, PhD CRNA
Phone
8584051003
Email
tsbevans@yahoo.com
Facility Information:
Facility Name
Knee Arthritis Clinical Trial Officew
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatjana Warren, PhD
Phone
801-970-2577

12. IPD Sharing Statement

Plan to Share IPD
No

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nCap Pain Relief Patch vs. Placebo

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