Thermal Energy in the Treatment of Cervicogenic Dizziness

Dizziness Clinical Trial

Official title:

Thermal Energy of Helical® Adhesive Pads in the Treatment of Cervicogenic Dizziness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05427097
• Other study ID #: 1.433.854
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2022
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 contraction.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cervical Pain
• Dizziness
• Neck Pain
• Vertigo

Intervention

Device:
• Helical® patches
Active Helical® patches and non-active patches (placebo) are placed at cervical tension points

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	60 days
Secondary	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.	60 days