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

Primary Purpose

Chronic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Neck, upper quadrant, upper body, chronic pain, sub-clinical pain, mild pain

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Loma Linda University Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

Subjects without Pain

Subjects with Pain and No Intervention

Subjects with Pain and Intervention

Arm Description

This group will include twenty participants with no neck and/or upper quadrant pain that will not receive transcutaneous electrical nerve stimulation treatment.

This group will include twenty participants with neck and/or upper quadrant pain that will not receive transcutaneous electrical nerve stimulation treatment.

This group will include twenty participants with neck and/or upper quadrant pain that will receive transcutaneous electrical nerve stimulation treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Level of anxiety
Assessed with the State-Trait Anxiety Inventory-form Y (STAI) which is a definitive clinical 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"). Higher scores indicate greater anxiety.

Full Information

First Posted
May 16, 2022
Last Updated
August 15, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT05382039
Brief Title
Effects of Electrotherapy on Pain, Anxiety, Motion and Disability in Adults With Neck or Upper Body Pain.
Official Title
Effects of Electrotherapy on Cervical Spine Proprioception, Pain, Anxiety, and Disability in Adults With Subclinical Neck or Upper Quadrant Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Neck, upper quadrant, upper body, chronic pain, sub-clinical pain, mild pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects without Pain
Arm Type
No Intervention
Arm Description
This group will include twenty participants with no neck and/or upper quadrant pain that will not receive transcutaneous electrical nerve stimulation treatment.
Arm Title
Subjects with Pain and No Intervention
Arm Type
No Intervention
Arm Description
This group will include twenty participants with neck and/or upper quadrant pain that will not receive transcutaneous electrical nerve stimulation treatment.
Arm Title
Subjects with Pain and Intervention
Arm Type
Experimental
Arm Description
This group will include twenty participants with neck and/or upper quadrant pain that will receive transcutaneous electrical nerve stimulation treatment.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Intervention Description
High frequency sensory transcutaneous electrical nerve stimulation
Primary Outcome Measure Information:
Title
Decrease in chronic subclinical neck or upper quadrant pain
Description
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.
Time Frame
Change between baseline assessment and Day Eight post-enrollment
Secondary Outcome Measure Information:
Title
Neck proprioception
Description
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.
Time Frame
Change between baseline assessment and Day Eight post-enrollment
Title
Level of anxiety
Description
Assessed with the State-Trait Anxiety Inventory-form Y (STAI) which is a definitive clinical 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"). Higher scores indicate greater anxiety.
Time Frame
Change between baseline assessment and Day Eight post-enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric G Johnson, DSc
Phone
909-558-4632
Ext
47471
Email
ejohnson@llu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Mleziva, Dr.
Phone
909-558-4632
Ext
85690
Email
pmleziva@llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Johnson, DSc
Organizational Affiliation
Loma Linda University Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Mleziva

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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