Healthy ParticipantsNCT05280522

Pain Inhibition With Neuromuscular Electrical Stimulation

An observational study of Healthy Participants, run by University of New England at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Volitional Contractions (VOL), Neuromuscular Electrical Stimulation (NMES) and Noxious Electrical Stimulation (NXES)
Type of treatment: Medical device
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 19 Oct 2018to 28 May 2019
Phase: Observational
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 18 to 30 years
All sexes
Healthy volunteers accepted
Adult

Study population: Healthy men and women between 18-30 years of age

Who may be able to join

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

Who cannot join

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;

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dizziness or unexplained falls;
problems with blood vessels or circulation or skin sensation;
cancer
are or could be pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Healthy Participants
Being tested: Volitional Contractions (VOL), Neuromuscular Electrical Stimulation (NMES), Noxious Electrical Stimulation (NXES)
Keywords: Transcutaneous Electric Nerve Stimulation, Noxious Electrical Stimulation, Pain Threshold, Muscle Contraction, Muscle Weakness, Pain Management, Quadriceps, Strength, Pain Inhibition
Medical subject headings: Muscle Weakness, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Volitional Contractions (VOL)Other
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.
Neuromuscular Electrical Stimulation (NMES)Device
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.
Noxious Electrical Stimulation (NXES)Device
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.

Study groups in NCT05280522
Study group	Role	What they receive
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. Receives: Other: Volitional Contractions (VOL); Device: Neuromuscular Electrical Stimulation (NMES); Device: Noxious Electrical Stimulation (NXES)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: day 2

Secondary outcomes (1)

Pain Ratings
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.
Measured: day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 201828 May 2019

First posted15 Mar 2022
Study start19 Oct 2018
Primary completion28 May 2019
Study completion28 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies 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: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05280522
Sponsor's protocol ID: 18.09.05-003
Status last verified: Feb 2022
First submitted: 14 Feb 2022
Last updated: 15 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Neuromuscular Electrical Stimulation on Pain
ClinicalTrials.gov ID: NCT05280522
Acronym / sponsor ID: 18.09.05-003
Conditions: Healthy Participants
Keywords: Transcutaneous Electric Nerve Stimulation, Noxious Electrical Stimulation, Pain Threshold, Muscle Contraction, Muscle Weakness, Pain Management, Quadriceps, Strength
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of New EnglandUniversity, hospital or other
Study start: 19 Oct 2018 (actual)
Primary completion: 28 May 2019 (actual)
Study completion: 28 May 2019 (actual)
First posted: 15 Mar 2022 (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 demonstrate the pain relieving effect of neuromuscular electrical stimulation that is applied for the purpose of increasing muscle force output.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Repeated Measures Experiment	–	Other: Volitional Contractions (VOL), Device: Neuromuscular Electrical Stimulation (NMES), Device: Noxious Electrical Stimulation (NXES)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.

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: Healthy men and women between 18-30 years of age

Key inclusion criteria (1 listed)

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

Key exclusion criteria (10 listed)

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;

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
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.	Other	Repeated Measures Experiment
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	Repeated Measures Experiment
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.	Device	Repeated Measures Experiment

Primary outcome

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.

1 secondary outcome

Pain Ratings
Time frame: day 2

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.

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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.

Katherine S Rudolph, PT, PhD principal investigator

University of New England Physical Therapy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Participants, run by University of New England 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 15 Mar 2022. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Inhibition (time frame: day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05280522.

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 15 Mar 2022.