Clinical trial NCT03291912: Chuna Manual Therapy for Cervicogenic Dizziness
Official title: Therapeutic Effect of Adjuvant Chuna Manual Therapy (CMT) in Subjects With Cervicogenic Dizziness: a Prospective, Pragmatic, Assessor-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cervicogenic Dizziness
Lead sponsor: Kyunghee University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, pragmatic, assessor-blind, randomized controlled trial to explore the effectiveness of an adjuvant Chuna manual therapy (CMT) for cervicogenic dizziness of Dizziness Handicap Inventory (DHI) ≥ 16 at baseline. Participants will be randomized and allocated to either CMT combined with usual care (UC) group or UC group with 1:1 ratio. They will receive 12 sessions of CMT or UC treatment for 6 weeks. UC consists of physical therapy and patients education.


Eligibility criteria: Inclusion Criteria:

* male or female aged between 20 and 70
* neck pain and/or stiffness with dizziness, which is related to movement or positioning of cervical spine
* recurring symptom of dizziness over 1 month or more
* Dizziness Handicap Inventory ≥ 16 at baseline
* Informed consent

Exclusion Criteria:

* dizziness induced by vestibular disorders (e.g., benign paroxysmal positional vertigo, peripheral vestibulopathy, Meniere disease, vestibular neuronitis)
* dizziness induced by central nervous system (CNS) disorders (e.g., cerebellar ataxia,cerebellum infarction/hemorrhage, demyelination, vertebrobasilar insufficiency, seizure, increased intracranial pressure, Parkinson's disease, migraines)
* dizziness induced by cardiovascular disorders (e.g., arrhythmia, heart valvular disease, anemia, orthostatic hypotension, coronary artery disease)
* dizziness induced by active or uncontrolled disease (e.g., uncontrolled diabetes mellitus, hypertension, respiratory or endocrinological disorders)
* dizziness induced by side effects of medications
* severe chronic or terminal diseases (malignant cancer, tuberculosis, etc.)
* chronic psychiatric diseases under treatment (epilepsy, depression, panic disorder, etc.)
* conditions where CMT are forbidden (spinal tumor, acute fracture, infectious spondylopathy, congenital malformations of spine, operation history of spine within 3 months, progressive neurological damage, severe neurological symptoms, spinal fixation devices, syringomyelia, hydrocephaly)
* Treatment history within 1 week for cervicogenic dizziness (NSAIDs, steroid, herbal drug, acupuncture, manual therapy)
* Women of (suspected) pregnancy or breast-feeding
* Suspicion of alcohol and/or drug abuse
* Participation in another clinical study within 1 month
* Difficulty in communicating with the investigators
* Other reasons for ineligibility of participation

Primary outcomes:
measure: Change from baseline Dizziness Handicap Inventory (DHI) score at week 6
timeFrame: Week 0, Week 6
Secondary outcomes:
measure: Change from baseline Dizziness Handicap Inventory (DHI) score at week 3
timeFrame: Week 0, Week 3
measure: Changes from baseline Mean Vertigo Score (MVS) at each measurement week
timeFrame: Week 0, Week 3, Week 6
measure: Changes from baseline Visual Analogue Scale (VAS) score at each measurement week
timeFrame: Week 0, Week 3, Week 6
measure: Changes from baseline Frequency of Dizziness score at each measurement week
timeFrame: Week 0, Week 3, Week 6
measure: Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week
timeFrame: Week 0, Week 3, Week 6
measure: Changes from baseline Neck Disability Index (NDI) score at each measurement week
timeFrame: Week 0, Week 3, Week 6
measure: Changes from baseline Cervical Range of Motion (CROM) value at each measurement week
timeFrame: Week 0, Week 3, Week 6
measure: Global Perceived Effect (GPE) score at each measurement week
timeFrame: Week 6
measure: Changes from baseline Korean version of Perceived Stress Scale (K-PSS) score at each measurement week
timeFrame: Week 0, Week 3, Week 6
measure: Changes from baseline EuroQoL Five Dimensions Questionnaire (EQ-5D) score at each measurement week
timeFrame: Week 0, Week 3, Week 6
Other outcomes:
measure: New Blinding Index (New BI)
timeFrame: Week 6
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital
state: Special Seoul City
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital at Gangdong
Study officials:
affiliation: Kyunghee University
name: Euiju Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reid SA, Callister R, Snodgrass SJ, Katekar MG, Rivett DA. Manual therapy for cervicogenic dizziness: Long-term outcomes of a randomised trial. Man Ther. 2015 Feb;20(1):148-56. doi: 10.1016/j.math.2014.08.003. Epub 2014 Aug 27.
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citation: Yacovino DA, Hain TC. Clinical characteristics of cervicogenic-related dizziness and vertigo. Semin Neurol. 2013 Jul;33(3):244-55. doi: 10.1055/s-0033-1354592. Epub 2013 Sep 21.
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citation: Reid SA, Rivett DA. Manual therapy treatment of cervicogenic dizziness: a systematic review. Man Ther. 2005 Feb;10(1):4-13. doi: 10.1016/j.math.2004.03.006.
citation: Reid SA, Rivett DA, Katekar MG, Callister R. Efficacy of manual therapy treatments for people with cervicogenic dizziness and pain: protocol of a randomised controlled trial. BMC Musculoskelet Disord. 2012 Oct 18;13:201. doi: 10.1186/1471-2474-13-201.
citation: Karlberg M, Magnusson M, Malmstrom EM, Melander A, Moritz U. Postural and symptomatic improvement after physiotherapy in patients with dizziness of suspected cervical origin. Arch Phys Med Rehabil. 1996 Sep;77(9):874-82. doi: 10.1016/s0003-9993(96)90273-7.
citation: Heikkila H, Johansson M, Wenngren BI. Effects of acupuncture, cervical manipulation and NSAID therapy on dizziness and impaired head repositioning of suspected cervical origin: a pilot study. Man Ther. 2000 Aug;5(3):151-7. doi: 10.1054/math.2000.0357.
citation: Minguez-Zuazo A, Grande-Alonso M, Saiz BM, La Touche R, Lara SL. Therapeutic patient education and exercise therapy in patients with cervicogenic dizziness: a prospective case series clinical study. J Exerc Rehabil. 2016 Jun 30;12(3):216-25. doi: 10.12965/jer.1632564.282. eCollection 2016 Jun.