Chuna Manual Therapy for Cervicogenic Dizziness

NCT03291912 | Withdrawn

• 1 other identifier: HB16C0010-CMT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervicogenic Dizziness

Outcome Measures

Primary Outcomes (1)

• Change from baseline Dizziness Handicap Inventory (DHI) score at week 6

  Week 0, Week 6

Secondary Outcomes (10)

• Change from baseline Dizziness Handicap Inventory (DHI) score at week 3

  Week 0, Week 3

• Changes from baseline Mean Vertigo Score (MVS) at each measurement week

  Week 0, Week 3, Week 6

• Changes from baseline Visual Analogue Scale (VAS) score at each measurement week

  Week 0, Week 3, Week 6

• Changes from baseline Frequency of Dizziness score at each measurement week

  Week 0, Week 3, Week 6

• Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week

  Week 0, Week 3, Week 6

Other Outcomes (1)

• New Blinding Index (New BI)

  Week 6

Study Arms (2)

Chuna Manual Therapy (CMT)

EXPERIMENTAL

1. Chuna manual therapy (CMT), 2 sessions/week, 6 weeks (12 sessions in total) 2. Usual care therapy (UC), 2 sessions/week, 6 weeks (12 sessions in total) * Usual care consists of physical therapy and patients education. Physical therapy consists of meridian muscle interferential current electricity (or meridian transcutaneous electricity) and hot pack (or infrared lamp). * Patients will be educated about cause and risk factors of cervicogenic dizziness, general neck muscle functions, self-exercising for relieving the symptoms. * CMT and UC group will receive the same UC regimen.

Procedure: Chuna Manual Therapy; Procedure: Usual care

Usual Care (UC)

ACTIVE COMPARATOR

Usual care therapy (UC), 2 sessions/week, 6 weeks (12 sessions in total) * Usual care consists of physical therapy and patients education. Physical therapy consists of meridian muscle interferential current electricity (or meridian transcutaneous electricity) and hot pack (or infrared lamp). * Patients will be educated about cause and risk factors of cervicogenic dizziness, general neck muscle functions, self-exercising for relieving the symptoms. * CMT and UC group will receive the same UC regimen.

Procedure: Usual care

Interventions

Chuna Manual Therapy PROCEDURE

* 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)

Chuna Manual Therapy (CMT)

Usual care PROCEDURE

1. 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 2. 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

Chuna Manual Therapy (CMT); Usual Care (UC)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University: lead

Study Sites (2)

Kyung Hee University Korean Medicine Hospital

Seoul, Special Seoul City, 02447, South Korea

Location

Kyung Hee University Korean Medicine Hospital at Gangdong

Seoul, 05278, South Korea

Location

Related Publications (10)

• 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.

  PMID: 25220110 BACKGROUND

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

  PMID: 26218949 BACKGROUND

• 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.

  PMID: 24057828 BACKGROUND

• RYAN GM, COPE S. Cervical vertigo. Lancet. 1955 Dec 31;269(6905):1355-8. doi: 10.1016/s0140-6736(55)93159-7. No abstract available.

  PMID: 13279136 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 15681263 BACKGROUND

• 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.

  PMID: 23078200 BACKGROUND

• 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.

  PMID: 8822677 BACKGROUND

• 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.

  PMID: 11034885 BACKGROUND

• 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.

  PMID: 27419118 BACKGROUND

Study Officials

• Euiju Lee, Ph.D.

  Kyunghee University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Ph.D. KMD.

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 3, 2018

Record last verified: 2018-01

Locations

KR (2)