Trial Outcomes & Findings for Effects of Electrotherapy on Pain, Anxiety, Motion and Disability in Adults With Neck or Upper Body Pain. (NCT NCT05382039)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

Change between baseline and two weeks from time of enrollment

Results posted on

2024-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects Without Pain This group included twenty participants with no neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment.	Subjects With Pain and No Intervention This group included twelve participants with neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment.	Subjects With Pain and Intervention This group included eleven participants with neck and/or upper quadrant pain that did receive transcutaneous electrical nerve stimulation treatment. Transcutaneous Electrical Nerve Stimulation: High frequency sensory transcutaneous electrical nerve stimulation
Overall Study STARTED	21	12	12
Overall Study COMPLETED	16	12	10
Overall Study NOT COMPLETED	5	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects Without Pain This group included twenty participants with no neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment.	Subjects With Pain and Intervention This group included eleven participants with neck and/or upper quadrant pain that did receive transcutaneous electrical nerve stimulation treatment. Transcutaneous Electrical Nerve Stimulation: High frequency sensory transcutaneous electrical nerve stimulation
Overall Study Score on pain scale was not zero. Subjects randomized to this arm had to have zero pain.	5	0
Overall Study One subject unable to return for reassessment as required by protocol timeline.	0	1
Overall Study waiting for confirmation	0	1

Baseline Characteristics

1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Without Pain n=16 Participants This group included twenty participants with no neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment.	Subjects With Pain and No Intervention n=12 Participants This group included twelve participants with neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment.	Subjects With Pain and Intervention n=10 Participants This group included eleven participants with neck and/or upper quadrant pain that did receive transcutaneous electrical nerve stimulation treatment. Transcutaneous Electrical Nerve Stimulation: High frequency sensory transcutaneous electrical nerve stimulation	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=16 Participants • 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	0 Participants n=12 Participants • 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	0 Participants n=10 Participants • 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	0 Participants n=38 Participants • 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.
Age, Categorical Between 18 and 65 years	16 Participants n=16 Participants • 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	12 Participants n=12 Participants • 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	10 Participants n=10 Participants • 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	38 Participants n=38 Participants • 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.
Age, Categorical >=65 years	0 Participants n=16 Participants • 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	0 Participants n=12 Participants • 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	0 Participants n=10 Participants • 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	0 Participants n=38 Participants • 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.
Sex: Female, Male Female	12 Participants n=16 Participants • Unable to analyze 7 subjects due to: 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	11 Participants n=12 Participants • Unable to analyze 7 subjects due to: 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	5 Participants n=10 Participants • Unable to analyze 7 subjects due to: 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	28 Participants n=38 Participants • Unable to analyze 7 subjects due to: 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.
Sex: Female, Male Male	4 Participants n=16 Participants • Unable to analyze 7 subjects due to: 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	1 Participants n=12 Participants • Unable to analyze 7 subjects due to: 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	5 Participants n=10 Participants • Unable to analyze 7 subjects due to: 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.	10 Participants n=38 Participants • Unable to analyze 7 subjects due to: 1 subject (pain and intervention) unable to return after two weeks for reassessment. 1 subject (pain and intervention) unable to complete data collection due to a pain score VAS \>4/10. 1 subject (no pain) unable to complete data due to lightheadedness. 4 subjects (no pain) excluded due to a pain score \>0/10.
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	16 participants n=16 Participants	12 participants n=12 Participants	10 participants n=10 Participants	38 participants n=38 Participants

PRIMARY outcome

Timeframe: Change between baseline and two weeks from time of enrollment

Population: 16 subjects (without pain) were analyzed that reflects outcome measure below

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.

Outcome measures

Outcome measures
Measure	Subjects Without Pain n=16 Participants This group included twenty participants with no neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment.	Subjects With Pain and No Intervention n=12 Participants This group included twelve participants with neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment.	Subjects With Pain and Intervention n=10 Participants This group included eleven participants with neck and/or upper quadrant pain that did receive transcutaneous electrical nerve stimulation treatment. Transcutaneous Electrical Nerve Stimulation: High frequency sensory transcutaneous electrical nerve stimulation
Decrease in Chronic Subclinical Neck or Upper Quadrant Pain	0 cm Interval 0.0 to 0.0	2.0 cm Interval 0.1 to 3.8	2.0 cm Interval 0.1 to 3.8

SECONDARY outcome

Timeframe: Baseline

Population: 16 subjects (without pain) were analyzed that reflects outcome measure below

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.

Outcome measures

Outcome measures
Measure	Subjects Without Pain n=16 Participants This group included twenty participants with no neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment.	Subjects With Pain and No Intervention n=12 Participants This group included twelve participants with neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment.	Subjects With Pain and Intervention n=10 Participants This group included eleven participants with neck and/or upper quadrant pain that did receive transcutaneous electrical nerve stimulation treatment. Transcutaneous Electrical Nerve Stimulation: High frequency sensory transcutaneous electrical nerve stimulation
Neck Proprioception	4.2 degrees Standard Deviation 2.3	4.7 degrees Standard Deviation 4.2	4.7 degrees Standard Deviation 4.2

SECONDARY outcome

Timeframe: Change between baseline and two weeks post-enrollment

Population: 16 subjects (without pain) were analyzed that reflects outcome measure below

Assessed with the State-Trait Anxiety Inventory-form Y (STAI) which is a definitive clinical composite 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") for a potential total of 80 points. A score of zero points represents no anxiety. A score of 80 points represents severe anxiety.

Outcome measures

Outcome measures
Measure	Subjects Without Pain n=16 Participants This group included twenty participants with no neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment.	Subjects With Pain and No Intervention n=12 Participants This group included twelve participants with neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment.	Subjects With Pain and Intervention n=10 Participants This group included eleven participants with neck and/or upper quadrant pain that did receive transcutaneous electrical nerve stimulation treatment. Transcutaneous Electrical Nerve Stimulation: High frequency sensory transcutaneous electrical nerve stimulation
Level of Anxiety	13.5 score on a scale Standard Deviation 4.8	18.0 score on a scale Standard Deviation 7.0	18.0 score on a scale Standard Deviation 7.0

Adverse Events

Subjects Without Pain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subjects With Pain and No Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subjects With Pain and Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Johnson

Loma Linda University

Phone: 9095584632

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place