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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation | Device | High frequency sensory transcutaneous electrical nerve stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Johnson, DSc | Loma Linda University Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health | Loma Linda | California | 92354 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Unable to analyze 7 subjects due to:
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Subjects With Pain and No Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 16 subjects (without pain) were analyzed that reflects outcome measure below | Posted | Median | Full Range | cm | Change between baseline and two weeks from time of enrollment |
|
2 weeks post enrollment
No adverse events noted
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Without Pain | This group included sixteen participants with no neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Johnson | Loma Linda University | 9095584632 | 47471 | ejohnson@llu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 29, 2022 | Mar 1, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2022 | Mar 1, 2024 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Prospective randomized controlled trial
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| 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. | Change between baseline and two weeks post-enrollment |
| waiting for confirmation |
|
This group included twelve participants with neck and/or upper quadrant pain that did not receive transcutaneous electrical nerve stimulation treatment.
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
| OG002 | 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 |
|
|
| Secondary | 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. | 16 subjects (without pain) were analyzed that reflects outcome measure below | Posted | Mean | Standard Deviation | degrees | Baseline |
|
|
|
| Secondary | 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. | 16 subjects (without pain) were analyzed that reflects outcome measure below | Posted | Mean | Standard Deviation | score on a scale | Change between baseline and two weeks post-enrollment |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Subjects With Pain and Intervention | This group included ten 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 | 0 | 10 | 0 | 10 | 0 | 10 |
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| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|