Thermal Energy in the Treatment of Cervicogenic Dizziness

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05427097

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

Enrollment

Location

Arms

43.1

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dizziness Cervical Pain	Device: Helical® patches	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two groups, one placebo and one interventionTwo groups, one placebo and one intervention

Masking:

Triple (Participant, Care Provider, 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 26, 2018

Actual Primary Completion Date :

Nov 1, 2021

Actual Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active 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 Active Helical® patches and non-active patches (placebo) are placed at cervical tension points Other Names: Non-active patches
Placebo Comparator: Placebo 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 Active Helical® patches and non-active patches (placebo) are placed at cervical tension points Other Names: Non-active patches

Arm

Intervention/Treatment

Active Comparator: Active

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

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

Other Names:

Non-active patches

Placebo Comparator: Placebo

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

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

Other Names:

Non-active patches

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Sao Paulo	São Paulo		Brazil	05403-010

Sponsors and Collaborators

University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Roseli Saraiva Moreira Bittar, Clinical Professor, University of Sao Paulo General Hospital

ClinicalTrials.gov Identifier:

NCT05427097

Other Study ID Numbers:

1.433.854

First Posted:

Jun 22, 2022

Last Update Posted:

Jun 28, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Roseli Saraiva Moreira Bittar, Clinical Professor, University of Sao Paulo General Hospital

Thermal

Vertigo

Additional relevant MeSH terms:

Vertigo

Dizziness

Neck Pain

Study Results

No Results Posted as of Jun 28, 2022