Skip to main content
OpenTrials
Completed

NCT Number: NCT05427097

Thermal Energy 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dizziness Cervical Pain Ear Diseases Labyrinth Diseases Neck Pain Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo

São Paulo, 05403-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Helical® patches

Device

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

Other names: Non-active patches

Primary outcomes

  1. 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.

Secondary outcomes

  1. Improvement of cervical neck pain

    Time frame: 60 days

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jun 22, 2022
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.