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

NCT05382039 | Completed Results FDA Device

• 1 other identifier: 5220149
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Neck, upper quadrant, upper body, chronic pain, sub-clinical pain, mild pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Neck Proprioception

  Baseline

• Level of Anxiety

  Change between baseline and two weeks post-enrollment

Study Arms (3)

Subjects without Pain

NO INTERVENTION

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

Subjects with Pain and No Intervention

NO INTERVENTION

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

Subjects with Pain and Intervention

EXPERIMENTAL

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

Device: Transcutaneous Electrical Nerve Stimulation

Interventions

Transcutaneous Electrical Nerve Stimulation DEVICE

High frequency sensory transcutaneous electrical nerve stimulation

Subjects with Pain and Intervention

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Eric Johnson
• Organization: Loma Linda University

ejohnson@llu.edu

9095584632

Study Officials

• Eric Johnson, DSc

  Loma Linda University Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Doctor of Physical Therapy Program & Director, Neuroscience Research Laboratory

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: February 3, 2023
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)