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Thermal Energy in the Treatment of Cervicogenic Dizziness

Primary Purpose

Dizziness, Cervical Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Helical® patches
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dizziness focused on measuring Thermal, Vertigo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active

Placebo

Arm 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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 12, 2022
Last Updated
June 21, 2022
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05427097
Brief Title
Thermal Energy in the Treatment of Cervicogenic Dizziness
Official Title
Thermal Energy of Helical® Adhesive Pads in the Treatment of Cervicogenic Dizziness
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness, Cervical Pain
Keywords
Thermal, Vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups, one placebo and one intervention
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm 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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
Helical® patches
Other Intervention Name(s)
Non-active patches
Intervention Description
Active Helical® patches and non-active patches (placebo) are placed at cervical tension points
Primary Outcome Measure Information:
Title
Improvement of dizziness
Description
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.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Improvement of cervical neck pain
Description
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.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Sao Paulo
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28050200
Citation
Bittar R, Alves NG, Bertoldo C, Brugnera C, Oiticica J. Efficacy of Carbon Microcoils in Relieving Cervicogenic Dizziness. Int Arch Otorhinolaryngol. 2017 Jan;21(1):4-7. doi: 10.1055/s-0036-1592418. Epub 2016 Oct 26.
Results Reference
result

Learn more about this trial

Thermal Energy in the Treatment of Cervicogenic Dizziness

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