Recruiting

nCap

Sponsor:

nCap Medical

Code:

NCT04753567

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

nCap pain relief patch

Sham Patch

Study Details

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.

Conditions

Osteoarthritis, Knee

Study ID

NCT04753567

Start date

Apr 16, 2021

Status verified date

Apr, 2021

Completion date

Apr, 2022

Anticipated

Primary completion date

Apr, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Actual pain patch

placebo comparator: Sham patch

Interventions

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

Primary outcome measure

  • Pain score using VAS scale [ Time Frame: After 30 minutes of use ]

Central Contacts and Locations

Central contacts

Tatjana Warren, PhD CRNA

8584051003tsbevans@yahoo.com

Locations

Knee Arthritis Clinical Trial Officew

Recruiting

Salt Lake City, Utah, United States, 84107

Contacts

Tatjana Warren, PhD

801-970-2577

More Information

Sponsor

nCap Medical

Last update posted

Apr 20, 2021

Last verified

Apr, 2021

Keywords

  • pain, arthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by nCap Medical on 2021-04-20.