NCT05427097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

3.1 years

First QC Date

June 12, 2022

Last Update Submit

June 21, 2022

Conditions

DizzinessCervical Pain

Keywords

ThermalVertigo

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Improvement of cervical neck pain

    60 days

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Helical® patchesDEVICE

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

Also known as: Non-active patches
ActivePlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, 05403-010, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 28050200RESULT

MeSH Terms

Conditions

DizzinessNeck PainVertigo

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPainVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups, one placebo and one intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 12, 2022

First Posted

June 22, 2022

Study Start

September 26, 2018

Primary Completion

November 1, 2021

Study Completion

May 1, 2022

Last Updated

June 28, 2022

Record last verified: 2022-06

Locations

BR(1)