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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05382039
• Other study ID #: 5220149
• Status: Completed
• Phase: N/A
• Start date: February 3, 2023
• Est. completion date: March 17, 2023

Study information

• Verified date: May 2024
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 17, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Transcutaneous Electrical Nerve Stimulation
High frequency sensory transcutaneous electrical nerve stimulation

Locations

Country	Name	City	State
United States	Loma Linda University Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Chronic Subclinical Neck or Upper Quadrant Pain	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.	Change between baseline and two weeks from time of enrollment
Secondary	Neck Proprioception	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.	Baseline
Secondary	Level of Anxiety	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.	Change between baseline and two weeks post-enrollment