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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05427097
Other study ID # 1.433.854
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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