Cervical Pain, Dizziness
Conditions
Keywords
Thermal, Vertigo
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.
Interventions
DEVICEHelical® patches
Active Helical® patches and non-active patches (placebo) are placed at cervical tension points
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Randomization will be done by lottery. In a container, papers will be placed in the same number of study subjects and, then, the arm in which the subject will be allocated will be drawn. The team physiotherapist is blinded to the individual's allocation group.
Intervention model description
Two groups, one placebo and one intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Outcome results
None listed