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Completed

NCT Number: NCT05382039

Effects of Electrotherapy on Pain, Anxiety, Motion and Disability in Adults With Neck or Upper Body Pain.

This will be a prospective randomized controlled trial with sixty adults, 20 to 40 years of age. There will be three groups as follows: the normal group, control group, and intervention group where subjects will receive instructions for home use of TENS for pain reduction. The aim is for an equal distribution of males and females in each group.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Health

Loma Linda, California, 92354, United States

About this study

This will be a prospective randomized controlled trial with sixty adults, 20 to 40 years of age. There will be three groups as follows: twenty subjects with no pain in the normal group; forty subjects with chronic subclinical neck or upper quadrant pain will be randomized into two groups: twenty subjects in the control group, and twenty subjects in the intervention group. The aim is for an equal distribution of males and females in each group.

Data will be collected for each subject using the NORAXON® myoMOTION™ System, the visual analog scale (VAS), the State-Trait Anxiety Inventory (STAI), and the Neck Disability Index (NDI); all assessments will be made by a clinician.

Normal group (20 subjects): Initial assessment on day one and post assessments on day eight and on day thirty. Control group (20 subjects): Initial assessment on day one and post assessments on day eight and on day thirty. Intervention group (20 subjects): Initial assessment on day one pre-intervention and post-intervention assessment of high-frequency sensory TENS (gate control theory of pain) for thirty minutes followed by post-assessments in day eight and day thirty.

The intervention group will receive a thirty-minute high frequency TENS (gate control theory of pain) once a day for seven days and twenty-one days after the initial seven days to measure immediate and short-term effects on the dependent variables further described below. Subjects will be educated on TENS usage by a licensed physical therapist. A daily log will be given to all subjects in the intervention group to assure compliance with treatment. In addition, the TENS device will keep track of date, time and day of usage, and TENS parameters.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Subjects without Pain Group:

  • > 19 and <41 years of age
  • Currently enrolled as students at Loma Linda University.
  • No pain

Exclusion criteria

for Control Group:

  • Neck and/or upper quadrant pain
  • <20 years or >40 years of age

Inclusion criteria

for Subjects with Pain Groups:

  • >19 and <41 years of age
  • Currently enrolled as students at Loma Linda University
  • No acute pain
  • With neck and/or upper quadrant chronic pain
  • With <5/10 pain on the Visual Analog Scale (VAS)

Exclusion criteria

for Subjects with Pain Groups:

  • <20 years or >40 years of age
  • Acute pain
  • With >5/10 pain on the Visual Analog Scale (VAS)
  • Currently receiving clinical pain treatment
  • Pain medications within six hours of data collection
  • Contraindications for the use of electrotherapy

Treatment and study plan

Transcutaneous electrical nerve stimulation

Device

High frequency sensory transcutaneous electrical nerve stimulation

Primary outcomes

  1. Decrease in Chronic Subclinical Neck or Upper Quadrant Pain

    Time frame: Change between baseline and two weeks from time of enrollment

    Assessed with the Visual Analog Scale (VAS) which is a subjective measure of pain intensity consisting of a 10 centimeter (cm) line with anchor statements on the left (no pain) and extreme pain on the right. Pain scores will be determined by measuring the distance in cm from "no pain" or 0 cm to the participant's anchor point.

Secondary outcomes

  1. Neck Proprioception

    Time frame: Baseline

    Measurements assessed with NORAXON® myoMOTION™ System that is a composite measurement through an instrument that utilizes inertial measurement units (IMUs) to measure angles of motion in joints via sensors place on the head and neck. This system will measure cervical spine proprioception utilizing the joint position error (JPE) test by indicating the ability of a blindfolded subject to accurately reposition their head back to a predetermined neutral point after head movement.

  2. Level of Anxiety

    Time frame: Change between baseline and two weeks post-enrollment

    Assessed with the State-Trait Anxiety Inventory-form Y (STAI) which is a definitive clinical composite measure of state and trait anxiety in adults. Form Y has 20 items for assessing trait anxiety and 20 for state anxiety which will indicate how the subject feels "right now"/"at this moment" and how the subject "generally feels." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always") for a potential total of 80 points. A score of zero points represents no anxiety. A score of 80 points represents severe anxiety.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Effects of Electrotherapy on Cervical Spine Proprioception, Pain, Anxiety, and Disability in Adults With Subclinical Neck or Upper Quadrant Pain.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 19, 2022
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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