nCap Pain Relief Patch vs. Placebo

NCT ID: NCT04753567

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-16

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Actual pain patch

Group Type EXPERIMENTAL

nCap pain relief patch

Intervention Type DEVICE

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

Group Type PLACEBO_COMPARATOR

Sham Patch

Intervention Type DEVICE

Sham patch will be worn for 3 weeks exactly like actual pain patch

Interventions

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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

Intervention Type DEVICE

Sham Patch

Sham patch will be worn for 3 weeks exactly like actual pain patch

Intervention Type DEVICE

Eligibility Criteria

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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+)
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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nCap Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Knee Arthritis Clinical Trial Officew

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tatjana Warren, PhD CRNA

Role: CONTACT

8584051003

Facility Contacts

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Tatjana Warren, PhD

Role: primary

801-970-2577

Other Identifiers

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00127554

Identifier Type: -

Identifier Source: org_study_id

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