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

NCT ID: NCT05382039

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2023-03-17

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects without Pain

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Subjects with Pain and No Intervention

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Subjects with Pain and Intervention

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

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

High frequency sensory transcutaneous electrical nerve stimulation

Interventions

Transcutaneous Electrical Nerve Stimulation

High frequency sensory transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• >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

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

• <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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Eric Johnson

Associate Director, Doctor of Physical Therapy Program & Director, Neuroscience Research Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Johnson, DSc

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Health

Locations

Loma Linda University Health

Loma Linda, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

5220149

Identifier Type: -

Identifier Source: org_study_id