Thermal Energy in the Treatment of Cervicogenic Dizziness

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dizziness, Cervical Pain

Intervention / Treatment
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* Device: Helical® patches


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups, one placebo and one intervention
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>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<br>* Active Helical® patches and non-active patches (placebo) are placed at cervical tension points<br>* Other names: Non-active patches;|
| Placebo Comparator: Placebo<br>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<br>* Active Helical® patches and non-active patches (placebo) are placed at cervical tension points<br>* Other names: Non-active patches;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thermal, Vertigo