Pain Inhibition With Neuromuscular Electrical Stimulation
Influence of Neuromuscular Electrical Stimulation on Pain
1 other identifier
observational
20
1 country
1
Brief Summary
The purpose of this study is to demonstrate the pain relieving effect of neuromuscular electrical stimulation that is applied for the purpose of increasing muscle force output.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2019
CompletedFirst Submitted
Initial submission to the registry
February 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedMarch 15, 2022
February 1, 2022
7 months
February 14, 2022
March 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Inhibition
Pain inhibition will be assessed as the difference in pressure pain threshold (PPT) before and 15 minutes after each condition. PPT will be measured with a pain pressure algometer (Algomed, Medco, Durham, NC). Pressure will be applied over the quadriceps tendon 1 cm proximal to the patella through a 1.0 cm diameter tip at a rate of 30 kilopascals/second. Using a standard script, participants are asked to indicate when the sensation changes from deep pressure to pain. PPTs will be measured at the right (treatment) knee, as well as the contralateral knee and the distal phalanx of the middle finger of the right hand. Three consecutive PPTs will be measured at each site, with ≥ 30 s between each measurement. The last 2 measurements will be averaged and used in the analysis. The change in PPT before and after each condition will comprise the magnitude of pain inhibition.
day 2
Secondary Outcomes (1)
Pain Ratings
day 2
Study Arms (1)
Repeated Measures Experiment
Participants are positioned in an isokinetic dynamometer (Biodex System 4 Isokinetic Dynamometer , Biodex Medical Systems, Inc., Shirley, NY) with the knee flexed to approximately 90 degrees. After 3-4 submaximal warm up contractions, participants generate maximum knee extension force while vigorous verbal encouragement is provided. Two trials are collected with 30 seconds between trials. The maximum forces from the 2 trials is used to determine the target force of 20% MVIC used for the volitional and NMES contractions and to normalize the force of the muscle contractions.
Interventions
Participants are provided visual feedback showing the 20% MVIC force and instructed to produce the target force for 10 s then relax for 50 s. The timing is provided by the research personnel until 10 contractions are completed. Participants rate their pain during each contraction on a visual analog scale. The pain ratings are averaged across all 10 contractions and the average is used in the analysis.
Participants are instructed to relax throughout the NMES contractions. The amplitude of the stimulation is increased until 20 percent MVIC force is achieved and the amplitude is recorded. The timing of the NMES is 12 s on: 50 s off for 10 contractions. The on-time included a 2s ramp up to the target amplitude. Participants rate their pain during each contraction on a visual analog scale. The pain ratings were averaged across all 10 contractions and the average was used in the analyses.
The intensity of the electrical stimulation is increased slowly over 30 s to the maximum tolerated level. Trains of NXES are delivered at the maximum tolerated intensity with a timing ratio of 12 s on: 50 s off for a total of 10 trains. The on-time included a 2s ramp up to the target amplitude. Participants rate the pain during each contraction on a visual analog scale. The pain ratings were averaged across all 10 trains of NXES and the average is used in the analyses.
Eligibility Criteria
Healthy men and women between 18-30 years of age
You may qualify if:
- Young, healthy men and women between 18-30 years of age
You may not qualify if:
- high blood pressure or heart problems;
- Type II diabetes;
- Injury in the last 12 months to your feet, legs, back or spine that required the care of a medical professional;
- pain in the past 6 months that has lasted more than a few days;
- fibromyalgia or other chronic pain condition;
- neurological problems such as stroke;
- dizziness or unexplained falls;
- problems with blood vessels or circulation or skin sensation;
- cancer
- are or could be pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of New England Motion Analysis Lab
Portland, Maine, 04103-2656, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine S Rudolph, PT, PhD
University of New England Physical Therapy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2022
First Posted
March 15, 2022
Study Start
October 19, 2018
Primary Completion
May 28, 2019
Study Completion
May 28, 2019
Last Updated
March 15, 2022
Record last verified: 2022-02