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CHERIE: Chuna Manual Therapy for Cervicogenic Dizziness

Sponsor
Kyunghee University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03291912
Collaborator
(none)
0
Enrollment
2
Locations
2
Arms
22
Anticipated Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Chuna Manual Therapy
  • Procedure: Usual care
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Therapeutic Effect of Adjuvant Chuna Manual Therapy (CMT) in Subjects With Cervicogenic Dizziness: a Prospective, Pragmatic, Assessor-blind, Randomized Controlled Trial
Anticipated Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chuna Manual Therapy (CMT)

Chuna manual therapy (CMT), 2 sessions/week, 6 weeks (12 sessions in total) 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
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)

Procedure: 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
Active Comparator: Usual Care (UC)

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
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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline Dizziness Handicap Inventory (DHI) score at week 6 [Week 0, Week 6]

Secondary Outcome Measures

  1. Change from baseline Dizziness Handicap Inventory (DHI) score at week 3 [Week 0, Week 3]

  2. Changes from baseline Mean Vertigo Score (MVS) at each measurement week [Week 0, Week 3, Week 6]

  3. Changes from baseline Visual Analogue Scale (VAS) score at each measurement week [Week 0, Week 3, Week 6]

  4. Changes from baseline Frequency of Dizziness score at each measurement week [Week 0, Week 3, Week 6]

  5. Changes from baseline Pain Intensity Numerical Rating Scale (PI-NRS) score at each measurement week [Week 0, Week 3, Week 6]

  6. Changes from baseline Neck Disability Index (NDI) score at each measurement week [Week 0, Week 3, Week 6]

  7. Changes from baseline Cervical Range of Motion (CROM) value at each measurement week [Week 0, Week 3, Week 6]

  8. Global Perceived Effect (GPE) score at each measurement week [Week 6]

  9. Changes from baseline Korean version of Perceived Stress Scale (K-PSS) score at each measurement week [Week 0, Week 3, Week 6]

  10. Changes from baseline EuroQoL Five Dimensions Questionnaire (EQ-5D) score at each measurement week [Week 0, Week 3, Week 6]

Other Outcome Measures

  1. New Blinding Index (New BI) [Week 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kyung Hee University Korean Medicine Hospital Seoul Special Seoul City Korea, Republic of 02447
2 Kyung Hee University Korean Medicine Hospital at Gangdong Seoul Korea, Republic of 05278

Sponsors and Collaborators

  • Kyunghee University

Investigators

  • Principal Investigator: Euiju Lee, Ph.D., Kyunghee University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lee Eui-ju, Professor, Ph.D. KMD., Kyunghee University
ClinicalTrials.gov Identifier:
NCT03291912
Other Study ID Numbers:
  • HB16C0010-CMT
First Posted:
Sep 25, 2017
Last Update Posted:
Jan 3, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vertigo
Dizziness

Study Results

No Results Posted as of Jan 3, 2018