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Completed Not applicable Interventional

Influence of Noxious Electrical Stimulation on Chronic Pain From Knee Osteoarthritis

ClinicalTrials.gov ID: NCT04628013

Public ClinicalTrials.gov record NCT04628013. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Influence of Noxious Electrical Stimulation on Chronic Pain

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 clinical response. The hypothesis will be tested through 2 Specific Aims. Aim 1: The investigators will test the magnitude and duration of pain relief and functional improvement of a single treatment with NxES in adults with chronic knee OA pain. Aim 2: The investigators will determine if repeated NxES treatments show greater pain relief and/or functional improvements and if so, whether the gains plateau after a certain number of treatments. The knowledge gained by this study will be important to physical therapists and other health care practitioners who treat people with chronic knee osteoarthritic pain. If noxious electrical stimulation is found to be an effective strategy to decrease pain at rest and with movement, it may lead to improved patient care, improved function, and decreased chronic pain in people with knee osteoarthritis.

Study identification

NCT ID
NCT04628013
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of New England
Other
Enrollment
13 participants

Conditions and interventions

Eligibility (public fields only)

Age range
50 Years to 90 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 1, 2021
Primary completion
Dec 30, 2022
Completion
Dec 30, 2022
Last update posted
Aug 20, 2023

2021 – 2022

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of New England Portland Maine 04103

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04628013, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 20, 2023 · Synced Sep 10, 2026

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