Clinical trial NCT05280522: Pain Inhibition With Neuromuscular Electrical Stimulation
Official title: Influence of Neuromuscular Electrical Stimulation on Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Participants
Keywords: Transcutaneous Electric Nerve Stimulation
Noxious Electrical Stimulation
Pain Threshold
Muscle Contraction
Muscle Weakness
Pain Management
Quadriceps
Strength
Pain Inhibition
Lead sponsor: University of New England
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men and women between 18-30 years of age

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Inhibition
timeFrame: day 2
Secondary outcomes:
measure: Pain Ratings
timeFrame: day 2
Other outcomes:
Locations:
city: Portland
country: United States
facility: University of New England Motion Analysis Lab
state: Maine
Study officials:
affiliation: University of New England Physical Therapy
name: Katherine S Rudolph, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: