Clinical trial NCT05382039: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Neck, upper quadrant, upper body, chronic pain, sub-clinical pain, mild pain
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Decrease in Chronic Subclinical Neck or Upper Quadrant Pain
timeFrame: Change between baseline and two weeks from time of enrollment
Secondary outcomes:
measure: Neck Proprioception
timeFrame: Baseline
measure: Level of Anxiety
timeFrame: Change between baseline and two weeks post-enrollment
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda University Health
name: Eric Johnson, DSc
role: PRINCIPAL_INVESTIGATOR
References: