- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02199405
Study on the Early Warning and Treatment of Cervical Spondylosis of Cervical Type on Young People Based on the " Move Generate Yang " Theory
The incidence of cervical spondylosis on young people is increasing every year. Suffering from this disease will affect the normal life and learning of young people. Episode younger and incidence higher of this disease could increase health care spending of the government in the economy. Cervical spondylosis of cervical type is the main type of cervical spondylosis of young people. Patients of cervical spondylosis of cervical type always manifest the head, neck and shoulder pain accompanied by corresponding pressure point, the X-ray display of Upper cervical curvature change and instability of intervertebral joint performance ,and the dynamic lateral X-ray shows vertebral instability or trapezoidal change. The conservative treatment is the primary and preferred treatment of the disease.
This study is designed as a random, control, single blind study. It will recruit 140 cases of cervical spondylosis of cervical type. Both the treatment group and the control group will be randomly assigned 70 cases. Patients in the treatment group will be treated by Massage of chiropractic and adjusting cervical curvature and practice Sishi Daoyin for 4 weeks,and the control group by conventional massage and cervical traction. The total study includes 2 views that are baseline and post-4week intervention. At all of the 2 views, all participants will be examined range of motion of cervical vertebra, cervical curvature, and Surface Electromyography of neck muscles, and will be estimated scores of The Neck Disability Index(NDI), the Northwick Park Neck Pain Questionnaire (NPQ),Short-form McGill Pain Questionnaire(SF-MPQ) and Evaluation of the therapeutic effect. This study aims to investigate the efficacy of Massage of chiropractic and adjusting cervical curvature and Sishi Daoyin practice, and discover the correlation between these scales and these objective indicators to discover the indicators of early warning signs of cervical spondylosis of cervical type of young people.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tianjin
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Tianjin, Tianjin, China, 300193
- Recruiting
- The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
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Contact:
- Yucheng Wang, Bachelor
- Phone Number: 13752366330 022-27432186
- Email: wangyucheng2014512@126.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- meet the diagnostic criteria of cervical spondylosis of cervical type
- first invasion and not receive any treatment
- X-ray shows cervical curvature go straight
- volunteered to join the test, and sign " informed consent " persons
Exclusion Criteria:
- suspected or confirmed bone and joint and soft tissue tumors, and so on
- suffer from cardiovascular, lung, liver, kidney and hematopoietic system serious illness or impairment
- lesions of skin ( such as damage, burns, and so on ) where massage will be applied
- severe congenital malformation of cervical vertebra
- incapacitated or unable to independently read and write
- other conditions which researchers consider appropriate to participate in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: massage and Sishi Daoyin
Massage of chiropractic and adjusting cervical curvature, 10 minutes, three times one week for 4 weeks Sishi Daoyin, practicing during 9-11am, once a day for 4 weeks
|
Massage of chiropractic and adjusting cervical curvature, 10 minutes, three times one week for 4 weeks
Sishi Daoyin, practicing during 9-11am, once a day for 4 weeks
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Active Comparator: conventional massage and cervical traction
Conventional massage , 15 minutes, three times one week for 4 weeks Cervical traction , 15 minutes, three times one week for 4 weeks
|
Conventional massage , 15 minutes, three times one week for 4 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
value of cervical curvature
Time Frame: baseline and post- 4week intervention
|
We will examine the value of cervical curvature of participants at baseline and post- 4week intervention.
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baseline and post- 4week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
range of motion of cervical vertebra
Time Frame: baseline and post- 4week intervention
|
We will examine the range of motion of cervical vertebra, including cervical flexion, extension, flexion to the left, flexion to the right, rotation to the left and rotation to the right.
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baseline and post- 4week intervention
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value of Surface Electromyography of neck muscles
Time Frame: baseline and post- 4week intervention
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We will examine the value of Surface Electromyography of sternocleidomastoid muscle and upper trapezius muscle when they are cervical flexion, extension, flexion to the left and flexion to the right.
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baseline and post- 4week intervention
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scores of the Neck Disability Index(NDI)
Time Frame: baseline and post- 4week intervention
|
We will estimate the scores of NDI of participants.
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baseline and post- 4week intervention
|
scores of the Northwick Park Neck Pain Questionnaire (NPQ)
Time Frame: baseline and post- 4week intervention
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We will estimate the scores of NPQ of participants.
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baseline and post- 4week intervention
|
scores of Short-form McGill Pain Questionnaire(SF-MPQ)
Time Frame: baseline and post- 4week intervention
|
We will estimate the scores of SF-MPQ of participants.
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baseline and post- 4week intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
degree of Evaluation of the therapeutic effect
Time Frame: baseline and post- 4week intervention
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We will estimate the degree of Evaluation of the therapeutic effect according to Standards of the diagnosis and the therapeutic effect of Disease and Syndrome of traditional Chinese medicine.
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baseline and post- 4week intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13066
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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