Thermal Energy in the Treatment of Cervicogenic Dizziness

University of Sao Paulo General Hospital

Status: Completed

Conditions: Dizziness; Cervical Pain

Treatments: Device: Helical® patches

Study type: Interventional

Funder types: Other

Identifiers

NCT05427097

1.433.854

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

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).

Treatment:

Device: Helical® patches

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Device: Helical® patches