Low Back PainNCT05504369
Effects of Magnetic Tape on the Autonomic Nervous System
A study testing Magnetic tape in people with Low Back Pain, run by Florida Gulf Coast University at 1 site in Spain.
Trial summary
The effect of magnetic tape on pain and autonomic nervous system in subject with lower back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Magnetic tape
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current lower back pain with NPRS of 5
- Between ages 18-65
Who cannot join
- No lower back pain or pain <5 on the NPRS
- Not meeting age limit
- Having condition that prevents the PA procedure
- Conditions of the nervous system and inability keep eyes open
Trial locations and contacts
1 site in 1 country.
About this study
The effect of magnetic tape on pain and autonomic nervous system in subject with lower back pain.
Read the detailed description
The effects of magnetic nanoparticles in tape applied in the lumbar spine on the autonomic nervous system measured with fully automated pupillometry and on pain in the spine measured with posterior to anterior pressure on the spinous process and the skin pinch test paravertebrally
- Conditions
- Low Back Pain
- Being tested
- Magnetic tape, Placebo tape
- Keywords
- Magnetic tape, magnetic nano particles, Pupillometry, Autonomic nervous system, lower back pain, PA test, Skin pinch test
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic tapeOther
Tape with magnetic nanoparticles applied to the skin
Placebo tapeOther
Tape without nano particles applied to the skin
| Study group | Role | What they receive |
|---|---|---|
| Magnetic tape arm | Active comparator | Tape application bilaterally in the lumbar spine Receives: Other: Magnetic tape |
| Placebo tape arm | Sham comparator | Tape application bilaterally in the lumbar spine Receives: Other: Placebo tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillometry
1 minute continues pupil diameter measure
Measured: 60 seconds measure preceding tape application. After outcome 5
Pupillometry
1 minute continues pupil diameter measure
Measured: Second 60 second measure immediate after tape application. After outcome 1
Pupillometry
1 minute continues pupil diameter measure
Measured: Third 60 measure 3 minutes after the tape is removed. After outcome 2
Secondary outcomes (4)
PA spine
Anterior (PA) pressure on each spinal segment
Measured: First PA measure of 5 seconds on each PA of 5 seconds on each segment is starting off the measurement phase. This is the first outcome measure
Skin pinch test
Bilaterally of each vertebrae
Measured: 3 seconds skin pinch test at each level starting immediately following the first PA measure. After Outcome 4
PA spine
Anterior (PA) pressure on each spinal segment
Measured: Five second measure of PA of 5 seconds each segment is taken immediately after the third pupillometry measure (tape removed). After outcome 3
Skin Pinch test
Bilaterally of each vertebrae
Measured: 3 seconds skin pinch test at each level starting immediately following outcome 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Jan 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Single group design with random allocation of intervention placebo versus treatment tape. Next day other intervention was used
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Responsible party
- Principal investigator, Dr. Rob Sillevis,, Florida Gulf Coast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504369
- Sponsor's protocol ID
- 1240878
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan in place
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnetic Tape on the Autonomic Nervous System
- ClinicalTrials.gov ID
- NCT05504369
- Acronym / sponsor ID
- 1240878
- Conditions
- Low Back Pain
- Keywords
- Magnetic tape, magnetic nano particles, Pupillometry, Autonomic nervous system, lower back pain, PA test, Skin pinch test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Collaborators
- University of Valencia
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of magnetic tape on pain and autonomic nervous system in subject with lower back pain.
Detailed description
The effects of magnetic nanoparticles in tape applied in the lumbar spine on the autonomic nervous system measured with fully automated pupillometry and on pain in the spine measured with posterior to anterior pressure on the spinous process and the skin pinch test paravertebrally
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single group design with random allocation of intervention placebo versus treatment tape. Next day other intervention was used
| Arm | Type | Receives |
|---|---|---|
| Magnetic tape arm | Active comparator | Other: Magnetic tapeTape application bilaterally in the lumbar spine |
| Placebo tape arm | Sham comparator | Other: Placebo tapeTape application bilaterally in the lumbar spine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current lower back pain with NPRS of 5
- Between ages 18-65
Key exclusion criteria (4 listed)
- No lower back pain or pain <5 on the NPRS
- Not meeting age limit
- Having condition that prevents the PA procedure
- Conditions of the nervous system and inability keep eyes open
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 |
|---|---|---|
| Magnetic tapeTape with magnetic nanoparticles applied to the skin | Other | Magnetic tape arm |
| Placebo tapeTape without nano particles applied to the skin | Other | Placebo tape arm |
Primary outcome
Pupillometry
Time frame: 60 seconds measure preceding tape application. After outcome 5
1 minute continues pupil diameter measure
Pupillometry
Time frame: Second 60 second measure immediate after tape application. After outcome 1
1 minute continues pupil diameter measure
Pupillometry
Time frame: Third 60 measure 3 minutes after the tape is removed. After outcome 2
1 minute continues pupil diameter measure
4 secondary outcomes
PA spine
Time frame: First PA measure of 5 seconds on each PA of 5 seconds on each segment is starting off the measurement phase. This is the first outcome measure
Skin pinch test
Time frame: 3 seconds skin pinch test at each level starting immediately following the first PA measure. After Outcome 4
PA spine
Time frame: Five second measure of PA of 5 seconds each segment is taken immediately after the third pupillometry measure (tape removed). After outcome 3
Skin Pinch test
Time frame: 3 seconds skin pinch test at each level starting immediately following outcome 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: No. No plan in place
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic tape in people with Low Back Pain, run by Florida Gulf Coast University at 1 site in Spain.
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 2 inclusion and 4 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 17 Aug 2022. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pupillometry (time frame: 60 seconds measure preceding tape application. After outcome 5). The study lists 3 primary outcomes in all. 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 17 Aug 2022.