Chuna Manual Therapy for Cervicogenic Dizziness

Cervicogenic Dizziness Clinical Trial

— CHERIE  

Official title:

Therapeutic Effect of Adjuvant Chuna Manual Therapy (CMT) in Subjects With Cervicogenic Dizziness: a Prospective, Pragmatic, Assessor-blind, Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03291912
• Other study ID #: HB16C0010-CMT
• Status: Withdrawn
• Phase: N/A
• First received: September 19, 2017
• Last updated: January 2, 2018
• Start date: March 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2018
• Source: Kyunghee University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervicogenic Dizziness
• Dizziness
• Vertigo

Intervention

Procedure:
• Chuna Manual Therapy
Unique manual therapy in traditional Korean medicine Mandatory techniques for neck part and selective techniques for other part (if necessary) Selective techniques depends on a patient's condition (judged by traditional Korean medicine doctor)
• Usual care
Physical therapy based on traditional Korean medicine theory Electrical stimulation: either Meridian muscle interferential current electricity or Meridian transcutaneous electricity Heat stimulation: either Hot pack or Infrared lamp Patient education Physical and pathological explanation of cervicogenic dizziness Cause and risk factors of cervicogenic dizziness Functions of muscles related to cervicogenic dizziness Home exercising to self-manage cervicogenic dizziness

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Korean Medicine Hospital	Seoul	Special Seoul City
Korea, Republic of	Kyung Hee University Korean Medicine Hospital at Gangdong	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

Heikkilä 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. — View Citation

Karlberg M, Magnusson M, Malmström 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. — View Citation

Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95. Review. — View 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. — View 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. — View 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. — View Citation

Reid SA, Rivett DA. Manual therapy treatment of cervicogenic dizziness: a systematic review. Man Ther. 2005 Feb;10(1):4-13. Review. — View Citation

RYAN GM, COPE S. Cervical vertigo. Lancet. 1955 Dec 31;269(6905):1355-8. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New Blinding Index (New BI)		Week 6
Primary	Change from baseline Dizziness Handicap Inventory (DHI) score at week 6		Week 0, Week 6
Secondary	Change from baseline Dizziness Handicap Inventory (DHI) score at week 3		Week 0, Week 3
Secondary	Changes from baseline Mean Vertigo Score (MVS) at each measurement week		Week 0, Week 3, Week 6
Secondary	Changes from baseline Visual Analogue Scale (VAS) score at each measurement week		Week 0, Week 3, Week 6
Secondary	Changes from baseline Frequency of Dizziness score at each measurement week		Week 0, Week 3, Week 6
Secondary	Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week		Week 0, Week 3, Week 6
Secondary	Changes from baseline Neck Disability Index (NDI) score at each measurement week		Week 0, Week 3, Week 6
Secondary	Changes from baseline Cervical Range of Motion (CROM) value at each measurement week		Week 0, Week 3, Week 6
Secondary	Global Perceived Effect (GPE) score at each measurement week		Week 6
Secondary	Changes from baseline Korean version of Perceived Stress Scale (K-PSS) score at each measurement week		Week 0, Week 3, Week 6
Secondary	Changes from baseline EuroQoL Five Dimensions Questionnaire (EQ-5D) score at each measurement week		Week 0, Week 3, Week 6