An interventional study of Transcutaneous Electrical Nerve Stimulation in Chronic Pain, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
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.
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.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 45 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
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Inclusion Criteria for Subjects without Pain Group:
Exclusion Criteria for Control Group:
Inclusion Criteria for Subjects with Pain Groups:
Exclusion Criteria for Subjects with Pain Groups:
This group will include twenty participants with no neck and/or upper quadrant pain that will not receive transcutaneous electrical nerve stimulation treatment.
This group will include twenty participants with neck and/or upper quadrant pain that will not receive transcutaneous electrical nerve stimulation treatment.
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
High frequency sensory transcutaneous electrical nerve stimulation
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.
Time frame: Change between baseline and two weeks from time of enrollment
Neck Proprioception
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.
Time frame: Baseline
Level of Anxiety
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.
Time frame: Change between baseline and two weeks post-enrollment
| Milestone | Subjects Without Pain | Subjects With Pain and No Intervention | Subjects With Pain and Intervention |
|---|---|---|---|
| Started | 21 | 12 | 12 |
| Completed | 16 | 12 | 10 |
| Not completed | 5 | 0 | 2 |
| Withdrew: Score on pain scale was not zero. subjects randomized to this arm had to have zero pain. | 5 | 0 | 0 |
| Withdrew: One subject unable to return for reassessment as required by protocol timeline. | 0 | 0 | 1 |
| Withdrew: Waiting for confirmation | 0 | 0 | 1 |
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.
| cm | Subjects Without Pain | Subjects With Pain and No Intervention | Subjects With Pain and Intervention |
|---|---|---|---|
| Decrease in Chronic Subclinical Neck or Upper Quadrant Pain | 0 (0 to 0) | 2.0 (0.1 to 3.8) | 2.0 (0.1 to 3.8) |
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.
| degrees | Subjects Without Pain | Subjects With Pain and No Intervention | Subjects With Pain and Intervention |
|---|---|---|---|
| Neck Proprioception | 4.2 ± 2.3 | 4.7 ± 4.2 | 4.7 ± 4.2 |
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.
| score on a scale | Subjects Without Pain | Subjects With Pain and No Intervention | Subjects With Pain and Intervention |
|---|---|---|---|
| Level of Anxiety | 13.5 ± 4.8 | 18.0 ± 7.0 | 18.0 ± 7.0 |
Collected over 2 weeks post enrollment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects Without Pain | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Subjects With Pain and No Intervention | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Subjects With Pain and Intervention | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
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.
| Age, Categorical(Participants) | Subjects Without Pain | Subjects With Pain and No Intervention | Subjects With Pain and Intervention | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 12 | 10 | 38 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Subjects Without Pain | Subjects With Pain and No Intervention | Subjects With Pain and Intervention | Total |
|---|---|---|---|---|
| Female | 12 | 11 | 5 | 28 |
| Male | 4 | 1 | 5 | 10 |
| Race and Ethnicity Not Collected(Participants) | Subjects Without Pain | Subjects With Pain and No Intervention | Subjects With Pain and Intervention | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Subjects Without Pain | Subjects With Pain and No Intervention | Subjects With Pain and Intervention | Total |
|---|---|---|---|---|
| United States | 16 | 12 | 10 | 38 |
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