Back to resultsPostural and Clinical Outcomes of SNAGs Treatment in Cervicogenic Dizziness Patients: a Randomised Controlled Trial
Primary Purpose
Cervicogenic Dizziness, Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SNAGs Treatment
Sham Laser Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Cervicogenic Dizziness focused on measuring cervicogenic dizziness, sustained natural apophyseal glides, posturography testing, fast Fourier transform, cervical range of motion
Eligibility Criteria
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.
Sites / Locations
- UNITER ONLUS for balance and rehabilitation research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SNAGs treatment
Detuned Laser
Arm Description
cervicogenic patients will undergo SNAGs treatment. Based on personal history, the offending active cervical movement (i.e. the movement predominantly causing dizziness) will be identified and treatment direction will be determined. As suggested, the active movement to most likely cause dizziness is cervical extension, though also rotation or flexion will be shown to provoke it. With the participant in an upright sitting position, a skilled physiotherapist (blinded to the allocation) will apply a sustained passive accessory movement (glide) while the participant will be asked to move actively as allowed by his/her physiological range in the direction producing their symptoms. This procedure will be repeated six times.
cervicogenic patients will receive a sham treatment, carried out by the another skilled therapist (blinded to the allocation) and consisting in exposition to a detuned laser. A laser - deactivated by the manufacturer in order to produce no effective emission - will appear to operate normally, emitting a light signal and a beeping sound. Such procedure - which was shown to not activate somatosensory receptors and to have a very strong placebo effect - will be used for six applications, lasting 20 seconds, on various sites on the upper cervical spine, at a distance of 0.5-1cm from the skin.
Outcomes
Primary Outcome Measures
Balance Test
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.
Cervical Spine Movements
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 Outcome Measures
Self-report dizziness
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
Disability of the Neck
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
Pain of the Neck
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).
Fear of Movement
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
Anxiety and Depression
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
Full Information
NCT ID
NCT04347148
First Posted
April 7, 2020
Last Updated
April 10, 2020
Sponsor
Uniter Onlus
Collaborators
University of Rome Tor Vergata
1. Study Identification
Unique Protocol Identification Number
NCT04347148
Brief Title
Postural and Clinical Outcomes of SNAGs Treatment in Cervicogenic Dizziness Patients: a Randomised Controlled Trial
Official Title
Postural and Clinical Outcomes of SNAGs Treatment in Cervicogenic Dizziness Patients: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
March 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uniter Onlus
Collaborators
University of Rome Tor Vergata
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Dizziness, Rehabilitation
Keywords
cervicogenic dizziness, sustained natural apophyseal glides, posturography testing, fast Fourier transform, cervical range of motion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomly allocated to SNAGs (n = 41) or placebo (n = 39) treatment, constituted by a detuned laser. Both groups received their interventions 6 times over 4 weeks.
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SNAGs treatment
Arm Type
Experimental
Arm Description
cervicogenic patients will undergo SNAGs treatment. Based on personal history, the offending active cervical movement (i.e. the movement predominantly causing dizziness) will be identified and treatment direction will be determined. As suggested, the active movement to most likely cause dizziness is cervical extension, though also rotation or flexion will be shown to provoke it. With the participant in an upright sitting position, a skilled physiotherapist (blinded to the allocation) will apply a sustained passive accessory movement (glide) while the participant will be asked to move actively as allowed by his/her physiological range in the direction producing their symptoms. This procedure will be repeated six times.
Arm Title
Detuned Laser
Arm Type
Placebo Comparator
Arm Description
cervicogenic patients will receive a sham treatment, carried out by the another skilled therapist (blinded to the allocation) and consisting in exposition to a detuned laser. A laser - deactivated by the manufacturer in order to produce no effective emission - will appear to operate normally, emitting a light signal and a beeping sound. Such procedure - which was shown to not activate somatosensory receptors and to have a very strong placebo effect - will be used for six applications, lasting 20 seconds, on various sites on the upper cervical spine, at a distance of 0.5-1cm from the skin.
Intervention Type
Procedure
Intervention Name(s)
SNAGs Treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Laser Treatment
Intervention Description
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 Outcome Measure Information:
Title
Balance Test
Description
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.
Time Frame
one month
Title
Cervical Spine Movements
Description
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.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Self-report dizziness
Description
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
Time Frame
one month
Title
Disability of the Neck
Description
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
Time Frame
one month
Title
Pain of the Neck
Description
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).
Time Frame
one month
Title
Fear of Movement
Description
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
Time Frame
one month
Title
Anxiety and Depression
Description
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
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UNITER ONLUS for balance and rehabilitation research
City
Guidonia
State/Province
Rome
ZIP/Postal Code
00012
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25502050
Citation
Hain TC. Cervicogenic causes of vertigo. Curr Opin Neurol. 2015 Feb;28(1):69-73. doi: 10.1097/WCO.0000000000000161.
Results Reference
result
PubMed Identifier
21923933
Citation
Lystad RP, Bell G, Bonnevie-Svendsen M, Carter CV. Manual therapy with and without vestibular rehabilitation for cervicogenic dizziness: a systematic review. Chiropr Man Therap. 2011 Sep 18;19(1):21. doi: 10.1186/2045-709X-19-21.
Results Reference
result
PubMed Identifier
11153554
Citation
Wrisley DM, Sparto PJ, Whitney SL, Furman JM. Cervicogenic dizziness: a review of diagnosis and treatment. J Orthop Sports Phys Ther. 2000 Dec;30(12):755-66. doi: 10.2519/jospt.2000.30.12.755.
Results Reference
result
PubMed Identifier
24792139
Citation
Reid SA, Callister R, Katekar MG, Rivett DA. Effects of cervical spine manual therapy on range of motion, head repositioning, and balance in participants with cervicogenic dizziness: a randomized controlled trial. Arch Phys Med Rehabil. 2014 Sep;95(9):1603-12. doi: 10.1016/j.apmr.2014.04.009. Epub 2014 May 2.
Results Reference
result
PubMed Identifier
17951095
Citation
Reid SA, Rivett DA, Katekar MG, Callister R. Sustained natural apophyseal glides (SNAGs) are an effective treatment for cervicogenic dizziness. Man Ther. 2008 Aug;13(4):357-66. doi: 10.1016/j.math.2007.03.006. Epub 2007 Oct 22.
Results Reference
result
PubMed Identifier
31656108
Citation
Micarelli A, Viziano A, Augimeri I, Micarelli B, Capoccia D, Alessandrini M. Diagnostic route of cervicogenic dizziness: usefulness of posturography, objective and subjective testing implementation and their correlation. Disabil Rehabil. 2021 Jun;43(12):1730-1737. doi: 10.1080/09638288.2019.1680747. Epub 2019 Oct 26.
Results Reference
result
PubMed Identifier
27452617
Citation
Grande-Alonso M, Moral Saiz B, Minguez Zuazo A, Lerma Lara S, La Touche R. Biobehavioural analysis of the vestibular system and posture control in patients with cervicogenic dizziness. A cross-sectional study. Neurologia (Engl Ed). 2018 Mar;33(2):98-106. doi: 10.1016/j.nrl.2016.06.002. Epub 2016 Jul 21. English, Spanish.
Results Reference
result
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Postural and Clinical Outcomes of SNAGs Treatment in Cervicogenic Dizziness Patients: a Randomised Controlled Trial
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