Study Results
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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UNKNOWN
NA
70 participants
INTERVENTIONAL
2021-04-16
2022-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Actual pain patch
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
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
Sham Patch
Sham patch will be worn for 3 weeks exactly like actual pain patch
Eligibility Criteria
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Inclusion Criteria
* Male and Female Adults age 40-79
* VAS pain score of \> 4 at the beginning of the study
Exclusion Criteria
* 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+)
40 Years
79 Years
ALL
Yes
Sponsors
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nCap Medical
INDUSTRY
Responsible Party
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Locations
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Knee Arthritis Clinical Trial Officew
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Tatjana Warren, PhD
Role: primary
Other Identifiers
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00127554
Identifier Type: -
Identifier Source: org_study_id
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