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NCT04628013 · ClinicalTrials.gov registry record · NA

Influence of Noxious Electrical Stimulation on Chronic Pain From Knee Osteoarthritis

A NA study of Knee Osteoarthritis, sponsored by University of New England.

Completed
Registry status
NA
Development phase
13
Enrollment target
1
Study location

NCT04628013: Completed NA study of Knee Osteoarthritis, sponsored by University of New England.

NCT04628013 is a NA study of Knee Osteoarthritis that has completed, run by University of New England. The registered enrollment target is 13 participants, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04628013, a NA study of Knee Osteoarthritis, has completed, sponsored by University of New England.

COMPLETED
Registry status
NA
Development phase
13 participants
Enrollment target
1
Study location

Study Summary

Knee osteoarthritis (OA) is the most common lower extremity joint pain condition, and it is estimated that 15 million people in the US are living with symptomatic knee OA and that more than half (8 million) are under 65 years of age. To that end, the Centers for Disease Control and Prevention strongly recommends non-pharmacological treatments for chronic pain including physical therapy and weight loss; however, these interventions have significant barriers that can prevent their success. An intervention that targets pain specifically is transcutaneous electrical nerve stimulation (TENS), which is a low-cost intervention with evidence to support pain reduction. As used in the majority of research to date, the intervention called "TENS" refers to the application of electricity across the skin that produces a tingling sensation that is strong but comfortable. However, electricity is applied at a noxious level is thought to result in strong activation of the endogenous pain modulation system, thus producing longer-lasting pain inhibition. However, noxious electrical stimulation (NxES) has rarely been investigated as a treatment intervention. Recent studies, including our own, demonstrate that NxES produces immediate and potentially greater pain relief. Despite some promising research, the clinical use of NxES is sparse and more research is necessary to demonstrate its effects on resting pain, movement-related pain, physical function, and quality of life. The investigators hypothesize that the application of NxES will activate pain modulation mechanisms and change the pain modulation profile toward an anti-nociceptive state in adults with chronic knee osteoarthritis (OA) pain, and thereby decrease pain (at rest and with movement), improve physical function, and improve quality of life. The investigators expect individual differences; therefore, participants will be classified at baseline and their response to the intervention tracked using psychophysical tests and clinic

Primary Outcome

PPT will be measured using a pressure algometer (Wagner Instruments, USA; 1cm-squared rubber tip). Pressure will be applied and participants will indicate when the pressure turns to pain. Two trials from each test site with be averaged and used in the analysis. The change in the values from baseline across time points will be analyzed.

Conditions Studied

Interventions

  • DEVICE Noxious Electrical Stimulation (NxES)

Study Locations (1)

Maine

  • University of New England - Portland

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2021-08-02
Est. Completion 2022-12-31
Phase NA
University of New England

6 total trials

What the finished NCT04628013 record still lists

NCT04628013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which Noxious Electrical Stimulation (NxES) is the first listed.

NCT04628013 reports a single indexed study location in Maine.

Frequently Asked Questions

What is clinical trial NCT04628013 about?

NCT04628013 is a clinical study titled "Influence of Noxious Electrical Stimulation on Chronic Pain From Knee Osteoarthritis". Knee osteoarthritis (OA) is the most common lower extremity joint pain condition, and it is estimated that 15 million people in the US are living with symptomatic knee OA and that more than half (8 million) are under 65 years of age. To that end, the Centers for Disease Control and Prevention strong...

What is the current status of trial NCT04628013?

This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2021-08-02. Estimated completion is 2022-12-31.

What conditions does trial NCT04628013 study?

This clinical trial studies the following conditions: Knee Osteoarthritis.

What interventions are being tested in trial NCT04628013?

The interventions under investigation include: Noxious Electrical Stimulation (NxES) (DEVICE).

Who is sponsoring clinical trial NCT04628013?

This trial is sponsored by University of New England, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04628013 being conducted?

This trial has 1 study location across Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Knee Osteoarthritis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04628013's enrollment target sits among peer trials

13 99th of 101 higher than 3 of 101 other Knee Osteoarthritis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Knee Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04628013, the US trial registry maintained by the National Library of Medicine. NCT04628013 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.