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Completed

NCT Number: NCT04347148

Postural and Clinical Outcomes of SNAGs Treatment in Cervicogenic Dizziness Patients: a Randomised Controlled Trial

Previous works demonstrated the relationship between postural disturbances and reduction in cervical range of motion (CROM) in patients suffering from cervicogenic dizziness (CGD). Since sustained natural apophyseal glides (SNAGs) have been proposed as an effective treatment, the aim of the present study was to evaluate how clinical measures could be affected in patients with cervicogenic dizziness undergoing SNAGs.

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Key information

Conditions

Cervicogenic Dizziness Rehabilitation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNITER ONLUS for balance and rehabilitation research

Guidonia, Rome, 00012, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • accepted criteria will be operationalized to achieve the clinical suspicion of cervicogenic dizziness as following:
  • Exclusion of these differential diagnoses: a. Migrainous vertigo b. Vertigo of central origin c. Benign paroxysmal positional vertigo (BPPV) d. Meniere disease e. Vestibular neuritis f. Vertigo induced by drugs g. Psychogenic vertigo (anxiety and/or panic disorder and/or phobia) h. Orthostatic hypotension
  • presence of a subjective feeling of dizziness associated with pain, movement, rigidity, or certain positions of the neck at least from 3 months;
  • Cervical pain, trauma, and/or disease
  • If from traumatic origin, there has to be a temporal proximity between the onset of dizziness and the neck injury.

Diagnosis is positive if criteria 1 to 3 are fulfilled. As for criterion 2, dizziness had to occur during the same period than neck pain occurred and dizziness had to be proportional to the severity of the neck pain that generally fluctuates in time.

Criterion 4 addresses cervicogenic dizziness occurring after a neck trauma

Exclusion criteria

  • presence of trauma or recent surgery in the head, face, neck, or chest;
  • an otorhinolaryngological diagnosis of central or peripheral vertigo
  • receiving physiotherapy during the study period.
  • History, physical examination and a thorough clinical otoneurological examination will be devised to exclude extracervical causes of dizziness.
  • In order to exclude vestibular hypofunction, video Head Impulse Test - and the technique proposed in previous studies will be used to study the vestibulo-ocular reflex.

Treatment and study plan

SNAGs Treatment

Procedure

a sustained passive accessory movement (glide), i.e. SNAGs, will be applied by the physiotherapist while the participant will be asked to move actively as allowed by his/her physiological range in the direction producing his symptoms.

Sham Laser Treatment

Procedure

A Laser YAG 3 Chronic (Winform Medical Engineering s.r.l., San Donà di Piave (VE), Italy), will be detuned and applied in the region of cervical spine in order to have a sham treatment

Primary outcomes

  1. Balance Test

    Time frame: one month

    Study of the surface of the ellipse of confidence (calculated in mm) by means of static posturography platform will be used to assess the sway of the posture. Low levels of outcomes indicate better performances. No specific reference ranges are given in literature.

  2. Cervical Spine Movements

    Time frame: one month

    A cervical range of motion (CROM) goniometer, which has been shown to be a reliable tool with good validity, will be used to measure (in degrees) cervical spine movements. Active flexion, extension, left and right rotation, and left and right lateral flexion will be measured three times and then averaged. Low levels of outcomes indicate worse performances. No specific reference ranges are given in literature.

Secondary outcomes

  1. Self-report dizziness

    Time frame: one month

    The Italian Dizziness Handicap Inventory (DHI) wil be used to assess the self-report dizziness handicap. It consists of 25 questions designed to assess a patient's functional (nine questions), emotional (nine questions), and physical (seven questions) limitations; absolute scores range from 0 to 100, with moderate and severe disability usually associated with scores above 30 and 60, respectively

  2. Disability of the Neck

    Time frame: one month

    Level of neck spine disability will be assessed by means of Neck Disability Index (NDI). This self-report questionnaire has a single-factor structure comprising 10 items which assess different activities of daily living on a 6-point Likert-type scale (ranging from 0 to 5). Higher absolute scores indicate more severe pain and greater disability

  3. Pain of the Neck

    Time frame: one month

    Neck Pain Intensity (NPI) will be evaluated with the visual analogue scale for pain. This self-report reliable tool consists of a 100-mm horizontal line between the extremes 'no pain' (left) and 'worst imaginable pain' (right).

  4. Fear of Movement

    Time frame: one month

    Fear of movement will be quantified with the Tampa Scale for Kinesiophobia (TSK-17), a 17 item self-report questionnaire in which each question is scored using a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree); 4 items (4, 8, 12, and 16) are negatively worded and reverse scored. Higher absoute scores indicate a higher degree of kinesiophobia

  5. Anxiety and Depression

    Time frame: one month

    Anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale (HADS). This self-administered questionnaire contains 14 items, rated on a 4-point Likert type scale (from 0 to 3 points). The tool includes 2 subscales of 7 items that assess anxiety and depression. Higher absolute scores indicate higher levels of anxiety and depression in the 2 subscales, respectively

Sponsors and collaborators

Lead sponsor

Uniter Onlus

Other

Collaborators

  • University of Rome Tor Vergata

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 15, 2020
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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