DizzinessNCT05427097
Thermal Energy in the Treatment of Cervicogenic Dizziness
A study testing Helical® patches in people with Dizziness and Cervical Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Cervical pain contributes to postural deviations and imbalance. Nanotechnology may be used for the treatment of neck pain by fixing to the skin small rounds silicone patches containing double spiral carbon nanotubes arranged in the form of a coil (Helical), which would then relieve dizziness caused by muscular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dizziness, Cervical Pain
- What is being tested?
- Helical® patches
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Sep 2018to 1 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervicogenic Dizziness diagnosis
- Normal otoneurological examination
- Signed the informed consent form
- Neck without other radiological changes, which are not solely attributable to aging (osteophytosis, rectification, disc space reduction).
Who cannot join
- Active vestibular disease
- Traumatic neck injury
- Neurological
- Rheumatic or orthopedic diseases not attributable to aging (fractures, tumors) and/or that have surgical indication
- Somatoform diseases; cognitive limitations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thermal Energy of Helical® Adhesive Pads in the Treatment of Cervicogenic Dizziness
Cervical pain contributes to postural deviations and imbalance. Nanotechnology may be used for the treatment of neck pain by fixing to the skin small rounds silicone patches containing double spiral carbon nanotubes arranged in the form of a coil (Helical), which would then relieve dizziness caused by muscular contraction.
Read the detailed description
The selected patients should have neck pain arising from muscle contraction with loss of balance or instability lasting more than 90 days and normal electrooculography. Treatment consisted of placing 10 Helical patches, placebo or active, distributed as follows: two in the upper cervical area, two in the lower cervical area (near the 5th and 6th vertebrae), two in the upper trapezius muscle area (between neck and shoulder), and four in the tender point area (as reported by the patient). Using a Visual Analogue Scale (VAS) and specific questionnaires, the investigators will match pain, muscle tension and dizziness scores from Day 1 to those from Day 15 and Day 30.
- Conditions
- Dizziness, Cervical Pain
- Being tested
- Helical® patches
- Keywords
- Thermal, Vertigo
- Medical subject headings
- Dizziness, Neck Pain, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helical® patchesDevice
Also called Non-active patches
Active Helical® patches and non-active patches (placebo) are placed at cervical tension points
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | The treatment consisted of placing 10 active Helical patches spread as follows:
* Two in the upper cervical area (suboccipital);
* Two in the lower cervical area (near the 5th and 6th vertebrae);
* Two in the upper trapezius muscle area (between neck and shoulder);
* Four in the tender point area (as reported by the patient). Receives: Device: Helical® patches |
| Placebo | Placebo comparator | The treatment consisted of placing 10 placebo Helical patches spread as follows:
* Two in the upper cervical area (suboccipital);
* Two in the lower cervical area (near the 5th and 6th vertebrae);
* Two in the upper trapezius muscle area (between neck and shoulder);
* Four in the tender point area (as reported by the patient). Receives: Device: Helical® patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of dizziness
Improvement of dizziness indices provided by the visual analogue scale. Technically speaking, Visual Analog for Dizziness consists of a horizontal (or vertical) line, usually 100mm in length. The left end of the line signifies no dizziness which is depicted by a smiling face while the right end signifies the worst possible dizziness with a frowning face.
Measured: 60 days
Secondary outcomes (1)
Improvement of cervical neck pain
Improvement of cervical neck pain indices provided by the visual analogue scale.
Technically speaking, Visual Analog for Pain consists of a horizontal (or vertical) line, usually 100mm in length. The left end of the line signifies no pain which is depicted by a smiling face while the right end signifies the worst possible pain with a frowning face.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start26 Sep 2018
- Primary completion1 Nov 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Parallel groups
- Model description
- Two groups, one placebo and one intervention
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Roseli Saraiva Moreira Bittar, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427097
- Sponsor's protocol ID
- 1.433.854
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bittar R, Alves NG, Bertoldo C, Brugnera C, Oiticica J. Efficacy of Carbon Microcoils in Relieving Cervicogenic Dizziness. Int Arch Otorhinolaryngol. 2017 Jan;21(1):4-7. doi: 10.1055/s-0036-1592418. Epub 2016 Oct 26.
PubMed 28050200
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Energy of Helical® Adhesive Pads in the Treatment of Cervicogenic Dizziness
- ClinicalTrials.gov ID
- NCT05427097
- Acronym / sponsor ID
- 1.433.854
- Conditions
- Dizziness, Cervical Pain
- Keywords
- Thermal, Vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 22 Jun 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.
Cervical pain contributes to postural deviations and imbalance. Nanotechnology may be used for the treatment of neck pain by fixing to the skin small rounds silicone patches containing double spiral carbon nanotubes arranged in the form of a coil (Helical), which would then relieve dizziness caused by muscular contraction.
Detailed description
The selected patients should have neck pain arising from muscle contraction with loss of balance or instability lasting more than 90 days and normal electrooculography. Treatment consisted of placing 10 Helical patches, placebo or active, distributed as follows: two in the upper cervical area, two in the lower cervical area (near the 5th and 6th vertebrae), two in the upper trapezius muscle area (between neck and shoulder), and four in the tender point area (as reported by the patient). Using a Visual Analogue Scale (VAS) and specific questionnaires, the investigators will match pain, muscle tension and dizziness scores from Day 1 to those from Day 15 and Day 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups, one placebo and one intervention
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Helical® patchesThe treatment consisted of placing 10 active Helical patches spread as follows: * Two in the upper cervical area (suboccipital); * Two in the lower cervical area (near the 5th and 6th vertebrae); * Two in the upper trapezius muscle area (between neck and shoulder); * Four in the tender point area (as reported by the patient). |
| Placebo | Placebo comparator | Device: Helical® patchesThe treatment consisted of placing 10 placebo Helical patches spread as follows: * Two in the upper cervical area (suboccipital); * Two in the lower cervical area (near the 5th and 6th vertebrae); * Two in the upper trapezius muscle area (between neck and shoulder); * Four in the tender point area (as reported by the patient). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cervicogenic Dizziness diagnosis
- Normal otoneurological examination
- Signed the informed consent form
- Neck without other radiological changes, which are not solely attributable to aging (osteophytosis, rectification, disc space reduction).
Key exclusion criteria (5 listed)
- Active vestibular disease
- Traumatic neck injury
- Neurological
- Rheumatic or orthopedic diseases not attributable to aging (fractures, tumors) and/or that have surgical indication
- Somatoform diseases; cognitive limitations.
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 |
|---|---|---|
| Helical® patchesAlso: Non-active patchesActive Helical® patches and non-active patches (placebo) are placed at cervical tension points | Device | Active, Placebo |
Primary outcome
Improvement of dizziness
Time frame: 60 days
Improvement of dizziness indices provided by the visual analogue scale. Technically speaking, Visual Analog for Dizziness consists of a horizontal (or vertical) line, usually 100mm in length. The left end of the line signifies no dizziness which is depicted by a smiling face while the right end signifies the worst possible dizziness with a frowning face.
1 secondary outcome
Improvement of cervical neck pain
Time frame: 60 days
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 28 Jun 2022.
- Results publication: PubMed 28050200Bittar R, Alves NG, Bertoldo C, Brugnera C, Oiticica J. Efficacy of Carbon Microcoils in Relieving Cervicogenic Dizziness. Int Arch Otorhinolaryngol. 2017 Jan;21(1):4-7. doi: 10.1055/s-0036-1592418. Epub 2016 Oct 26.
- Individual participant dataSharing planned: Undecided
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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 Helical® patches in people with Dizziness and Cervical Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 inclusion and 5 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 28 Jun 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 Brazil. 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?
Improvement of dizziness (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05427097, which also lists 1 linked publication.
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 28 Jun 2022.