Chronic PainNCT05382039
Effects of Electrotherapy on Pain, Anxiety, Motion and Disability in Adults With Neck or Upper Body Pain.
A study testing Transcutaneous Electrical Nerve Stimulation in people with Chronic Pain, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2023to 17 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- > 19 and <41 years of age
- Currently enrolled as students at Loma Linda University.
- No pain
- >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)
Who cannot join
- Neck and/or upper quadrant pain
- <20 years or >40 years of age
- <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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health
Loma Linda, California, 92354
About this study
Official title: Effects of Electrotherapy on Cervical Spine Proprioception, Pain, Anxiety, and Disability in Adults With Subclinical Neck or Upper Quadrant Pain.
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Transcutaneous Electrical Nerve Stimulation
- Keywords
- Neck, upper quadrant, upper body, chronic pain, sub-clinical pain, mild pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
High frequency sensory transcutaneous electrical nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between baseline and two weeks from time of enrollment
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change between baseline and two weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start3 Feb 2023
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Prospective randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Johnson, Loma Linda University
- Investigators
- Eric Johnson, DSc, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382039
- Sponsor's protocol ID
- 5220149
- Status last verified
- May 2024
- First submitted
- 16 May 2022
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electrotherapy on Cervical Spine Proprioception, Pain, Anxiety, and Disability in Adults With Subclinical Neck or Upper Quadrant Pain.
- ClinicalTrials.gov ID
- NCT05382039
- Acronym / sponsor ID
- 5220149
- Conditions
- Chronic Pain
- Keywords
- Neck, upper quadrant, upper body, chronic pain, sub-clinical pain, mild pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Transcutaneous Electrical Nerve StimulationThis group will include twenty participants with neck and/or upper quadrant pain that will receive transcutaneous electrical nerve stimulation treatment. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- > 19 and <41 years of age
- Currently enrolled as students at Loma Linda University.
- No pain
- >19 and <41 years of age
- Currently enrolled as students at Loma Linda University
Key exclusion criteria (8 listed)
- Neck and/or upper quadrant pain
- <20 years or >40 years of age
- <20 years or >40 years of age
- Acute pain
- With >5/10 pain on the Visual Analog Scale (VAS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationHigh frequency sensory transcutaneous electrical nerve stimulation | Device | Subjects with Pain and Intervention |
Primary outcome
Decrease in Chronic Subclinical Neck or Upper Quadrant Pain
Time frame: 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.
2 secondary outcomes
Neck Proprioception
Time frame: Baseline
Level of Anxiety
Time frame: Change between baseline and two weeks post-enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Johnson, DSc principal investigator
Loma Linda University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation in people with Chronic Pain, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Chronic Subclinical Neck or Upper Quadrant Pain (time frame: Change between baseline and two weeks from time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.