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

NCT04347148 | Completed

• 1 other identifier: UniterSNAG
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervicogenic Dizziness; Rehabilitation

Keywords

cervicogenic dizziness; sustained natural apophyseal glides; posturography testing; fast Fourier transform; cervical range of motion

Outcome Measures

Primary Outcomes (2)

• 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.

  one month

• 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.

  one month

Secondary Outcomes (5)

• Self-report dizziness

  one month

• Disability of the Neck

  one month

• Pain of the Neck

  one month

• Fear of Movement

  one month

• Anxiety and Depression

  one month

Study Arms (2)

SNAGs treatment

EXPERIMENTAL

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.

Procedure: SNAGs Treatment

Detuned Laser

PLACEBO COMPARATOR

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.

Procedure: Sham Laser Treatment

Interventions

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.

SNAGs treatment

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

Detuned Laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• accepted criteria will be operationalized to achieve the clinical suspicion of cervicogenic dizziness as following:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uniter Onlus: lead
• University of Rome Tor Vergata: collaborator

Study Sites (1)

UNITER ONLUS for balance and rehabilitation research

Guidonia, Rome, 00012, Italy

Location

Related Publications (7)

• Hain TC. Cervicogenic causes of vertigo. Curr Opin Neurol. 2015 Feb;28(1):69-73. doi: 10.1097/WCO.0000000000000161.

  PMID: 25502050 RESULT

• 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.

  PMID: 21923933 RESULT

• 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.

  PMID: 11153554 RESULT

• 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.

  PMID: 24792139 RESULT

• 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.

  PMID: 17951095 RESULT

• 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.

  PMID: 31656108 RESULT

• 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.

  PMID: 27452617 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 15, 2020
• Study Start: March 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: March 2, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)