Osteoarthritis, KneeNCT04753567
nCap Pain Relief Patch vs. Placebo
A study testing nCap pain relief patch in people with Osteoarthritis, Knee, run by nCap Medical at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- nCap pain relief patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2021to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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+)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Knee Arthritis Clinical Trial Officew
Salt Lake City, Utah, 84107
Tatjana Warren, PhD, 801-970-2577
About this study
Official title: 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- nCap pain relief patch, Sham Patch
- Keywords
- pain, arthritis
- Medical subject headings
- Osteoarthritis, Knee, Pain, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCap pain relief patchDevice
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 PatchDevice
Sham patch will be worn for 3 weeks exactly like actual pain patch
| Study group | Role | What they receive |
|---|---|---|
| Actual pain patch | Experimental | Not described Receives: Device: nCap pain relief patch |
| Sham patch | Placebo comparator | Not described Receives: Device: Sham Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score using VAS scale
0-10 pain scale
Measured: After 30 minutes of use
Secondary outcomes (4)
WOMAC score
arthritis assessment score
Measured: 3 weeks
Sustained pain response
0-10 VAS pain score
Measured: 3 weeks
Global assessment question
How the patient feels they are doing
Measured: 3 weeks
Pain medication monitoring
Tylenol use
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start16 Apr 2021
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- nCap Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753567
- Sponsor's protocol ID
- 00127554
- Status last verified
- Apr 2021
- First submitted
- 9 Feb 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- nCap Medical Nano-Capacitive Pain Relief Patch vs Placebo, a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04753567
- Acronym / sponsor ID
- 00127554
- Conditions
- Osteoarthritis, Knee
- Keywords
- pain, arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- nCap MedicalIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actual pain patch | Experimental | Device: nCap pain relief patch |
| Sham patch | Placebo comparator | Device: Sham Patch |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nCap pain relief patchEach 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 | Device | Actual pain patch |
| Sham PatchSham patch will be worn for 3 weeks exactly like actual pain patch | Device | Sham patch |
Primary outcome
Pain score using VAS scale
Time frame: After 30 minutes of use
0-10 pain scale
4 secondary outcomes
WOMAC score
Time frame: 3 weeks
Sustained pain response
Time frame: 3 weeks
Global assessment question
Time frame: 3 weeks
Pain medication monitoring
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nCap pain relief patch in people with Osteoarthritis, Knee, run by nCap Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatjana Warren, PhD CRNA (8584051003, tsbevans@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score using VAS scale (time frame: After 30 minutes of use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.