Pain Inhibition With Neuromuscular Electrical Stimulation

March 4, 2022 updated by: University of New England

Influence of Neuromuscular Electrical Stimulation on Pain

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Electrical stimulation (ES) is used by physical therapists during treatment of many conditions including muscle weakness and pain. Neuromuscular electrical stimulation (NMES) is used to produce strength gains, but it is uncomfortable. The discomfort is thought to limit its acceptability by patients. Transcutaneous electrical stimulation (TENS) is the application of ES for pain relief. The intensity of TENS is strong but comfortable. The nervous system modulates pain in many ways, and one way that it can inhibit pain is through conditioned pain modulation; the "pain inhibits pain" phenomenon. Painful experiences can elicit inhibitory mechanisms that actually reduce pain. This study is designed to demonstrate that NMES elicited muscle contractions produce pain relieving effects that will benefit patients over and above the strengthening effects. Participants will be healthy young (18-30 years of age) who will rate their pain and undergo bilateral quantitative sensory testing of pressure pain over the right quadriceps tendon. They will experience three conditions: volitional contractions at 20 percent of the maximum voluntary isometric contraction (MVIC) force, electrically elicited contractions at 20 percent MVIC, and noxious electrical stimulation (NXES) at maximum tolerated intensity applied to the patella to prevent muscle contraction. Ten contractions or trains of stimulation will be applied at a ratio of 10 seconds on 50 seconds off to replicate the typical application of NMES for muscle strengthening. The order of the conditions will comprise: volitional contractions and NXES will be applied in a random order followed by NMES contractions. NMES was applied last to reduce any influence of muscle fatigue. Pressure pain thresholds (PPT) will be measured before and after each condition in both knees and the middle finder by applying pressure at a rate of 30 kilopascal/s. Participants will indicate immediately when the pressure turns to pain and the pressure will be recorded as their pain threshold. This will be repeated 3 times and the average of the last 2 measurements will be used in the analysis. Participants will rate their pain during the conditions using an 11-point visual analog scales in which 0= no pain and 10= the worst pain imaginable. Testing will take place over two sessions, in the Motion Analysis Laboratory of the University of New England separated by at least one hour. In session 1, participants will be familiarized with any procedures that could cause pain including pressure pain threshold testing, NMES elicited muscle contractions and noxious stimulation. The MVIC force of the quadriceps will also be measured and used to determine the goal force output for the volitional and electrically elicited contractions of 20 percent MVIC. In session 2, participants will undergo the testing procedures, each separated by at least 1 hour.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04103-2656
        • University of New England Motion Analysis Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy men and women between 18-30 years of age

Description

Inclusion Criteria:

Young, healthy men and women between 18-30 years of age

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Volitional Contractions (VOL)
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.
Device: Neuromuscular Electrical Stimulation (NMES)
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.
Device: Noxious Electrical Stimulation (NXES)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Inhibition
Time Frame: day 2
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Ratings
Time Frame: day 2
Participants will rate their pain during the conditions using a 100 mm visual analog scales in which 0= no pain and 100= the worst pain imaginable. Pain ratings from the 10 contractions or trains of NXES will be averaged and the average will be used in the analysis.
day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of New England

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine S Rudolph, PT, PhD, University of New England Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18.09.05-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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