Thermal Energy in the Treatment of Cervicogenic Dizziness

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.

Study Overview

• Status: Completed
• Conditions: Dizziness; Cervical Pain
• Intervention / Treatment: Device: Helical® patches

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-010
    • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; 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).	Device: Helical® patches; Active Helical® patches and non-active patches (placebo) are placed at cervical tension points; Other Names: Non-active patches
Placebo Comparator: Placebo; 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).	Device: Helical® patches; Active Helical® patches and non-active patches (placebo) are placed at cervical tension points; Other Names: Non-active patches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: June 12, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Vertigo; Thermal
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Neck Pain; Vertigo; Dizziness
• Other Study ID Numbers: 1.433.854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No