Chronic Pain
Conditions
Keywords
Neck, upper quadrant, upper body, chronic pain, sub-clinical pain, mild pain
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.
Interventions
DEVICETranscutaneous Electrical Nerve Stimulation
High frequency sensory transcutaneous electrical nerve stimulation
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Chronic Subclinical Neck or Upper Quadrant Pain | Change between baseline and two weeks from time of enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck Proprioception | Baseline | 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. |
| Level of Anxiety | Change between baseline and two weeks post-enrollment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 12 |
| 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 | 10 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | One subject unable to return for reassessment as required by protocol timeline. | 0 | 0 | 1 |
| Overall Study | Score on pain scale was not zero. Subjects randomized to this arm had to have zero pain. | 5 | 0 | 0 |
| Overall Study | waiting for confirmation | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Subjects With Pain and No Intervention | Subjects With Pain and Intervention | Subjects Without Pain |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 12 Participants | 10 Participants | 16 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment United States | 38 participants | 12 participants | 10 participants | 16 participants |
| Sex: Female, Male Female | 28 Participants | 11 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 1 Participants | 5 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 0 / 16 | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 16 | 0 / 12 | 0 / 10 |
Outcome results
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.
Time frame: Change between baseline and two weeks from time of enrollment
Population: 16 subjects (without pain) were analyzed that reflects outcome measure below
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subjects Without Pain | Decrease in Chronic Subclinical Neck or Upper Quadrant Pain | 0 cm |
| Subjects With Pain and No Intervention | Decrease in Chronic Subclinical Neck or Upper Quadrant Pain | 2.0 cm |
| Subjects With Pain and Intervention | Decrease in Chronic Subclinical Neck or Upper Quadrant Pain | 2.0 cm |
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.
Time frame: Change between baseline and two weeks post-enrollment
Population: 16 subjects (without pain) were analyzed that reflects outcome measure below
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Without Pain | Level of Anxiety | 13.5 score on a scale | Standard Deviation 4.8 |
| Subjects With Pain and No Intervention | Level of Anxiety | 18.0 score on a scale | Standard Deviation 7 |
| Subjects With Pain and Intervention | Level of Anxiety | 18.0 score on a scale | Standard Deviation 7 |
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.
Time frame: Baseline
Population: 16 subjects (without pain) were analyzed that reflects outcome measure below
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Without Pain | Neck Proprioception | 4.2 degrees | Standard Deviation 2.3 |
| Subjects With Pain and No Intervention | Neck Proprioception | 4.7 degrees | Standard Deviation 4.2 |
| Subjects With Pain and Intervention | Neck Proprioception | 4.7 degrees | Standard Deviation 4.2 |