Thermal Energy in the Treatment of Cervicogenic Dizziness

Not Applicable

Completed

• Conditions: Dizziness; Cervical Pain
• Interventions: Device: Helical® patches

• Registration Number: NCT05427097
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

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 Timeline

• Study Start: 2018-09-26
• Primary Completion: 2021-11-01
• Study Completion: 2022-05-01
• Status Verified: 2022-06
• Study First Submitted: 2022-06-12
• Study First Submitted QC: 2022-06-16
• Last Update Submitted: 2022-06-21
• Study First Posted: 2022-06-22
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Helical® patches	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).
Active	Helical® patches	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).

Primary Outcome Measures

Name	Time	Method
Improvement of dizziness	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 Outcome Measures

Name	Time	Method
Improvement of cervical neck pain	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.

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 São Paulo, Brazil