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

Loma Linda University (LLU)

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Transcutaneous Electrical Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05382039

5220149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Subjects without Pain

No Intervention group

Description:

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 group

Description:

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 group

Description:

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

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation