Study on the Early Warning and Treatment of Cervical Spondylosis of Cervical Type on Young People Based on the " Move Generate Yang " Theory
Primary Purpose
Cervical Spondylosis of Cervical Type
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Massage of chiropractic and adjusting cervical curvature
Sishi Daoyin
conventional massage
Cervical traction
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Spondylosis of Cervical Type focused on measuring Spondylosis, Massage Therapy, Exercise Therapy ,Treatment Efficacy
Eligibility Criteria
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
Sites / Locations
- The First Affiliated Hospital of Tianjin University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
massage and Sishi Daoyin
conventional massage and cervical traction
Arm Description
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
Conventional massage , 15 minutes, three times one week for 4 weeks Cervical traction , 15 minutes, three times one week for 4 weeks
Outcomes
Primary Outcome Measures
value of cervical curvature
We will examine the value of cervical curvature of participants at baseline and post- 4week intervention.
Secondary Outcome Measures
range of motion of cervical vertebra
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.
value of Surface Electromyography of neck muscles
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.
scores of the Neck Disability Index(NDI)
We will estimate the scores of NDI of participants.
scores of the Northwick Park Neck Pain Questionnaire (NPQ)
We will estimate the scores of NPQ of participants.
scores of Short-form McGill Pain Questionnaire(SF-MPQ)
We will estimate the scores of SF-MPQ of participants.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02199405
Brief Title
Study on the Early Warning and Treatment of Cervical Spondylosis of Cervical Type on Young People Based on the " Move Generate Yang " Theory
Official Title
Study on the Early Warning and Treatment of Cervical Spondylosis of Cervical Type on Young People Based on the " Move Generate Yang " Theory
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wang Yucheng
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Quality control: The study site and all researchers must comply with the required qualifications. All researchers must be trained before the study. The study will take a number of measures to ensure the recruitment of the required sample size, and compliance of intervention providers and participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis of Cervical Type
Keywords
Spondylosis, Massage Therapy, Exercise Therapy ,Treatment Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
massage and Sishi Daoyin
Arm Type
Experimental
Arm Description
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
Arm Title
conventional massage and cervical traction
Arm Type
Active Comparator
Arm Description
Conventional massage , 15 minutes, three times one week for 4 weeks Cervical traction , 15 minutes, three times one week for 4 weeks
Intervention Type
Other
Intervention Name(s)
Massage of chiropractic and adjusting cervical curvature
Intervention Description
Massage of chiropractic and adjusting cervical curvature, 10 minutes, three times one week for 4 weeks
Intervention Type
Other
Intervention Name(s)
Sishi Daoyin
Intervention Description
Sishi Daoyin, practicing during 9-11am, once a day for 4 weeks
Intervention Type
Other
Intervention Name(s)
conventional massage
Intervention Description
Conventional massage , 15 minutes, three times one week for 4 weeks
Intervention Type
Other
Intervention Name(s)
Cervical traction
Other Intervention Name(s)
Cervical traction , 15 minutes, three times one week for 4 weeks
Primary Outcome Measure Information:
Title
value of cervical curvature
Description
We will examine the value of cervical curvature of participants at baseline and post- 4week intervention.
Time Frame
baseline and post- 4week intervention
Secondary Outcome Measure Information:
Title
range of motion of cervical vertebra
Description
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.
Time Frame
baseline and post- 4week intervention
Title
value of Surface Electromyography of neck muscles
Description
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.
Time Frame
baseline and post- 4week intervention
Title
scores of the Neck Disability Index(NDI)
Description
We will estimate the scores of NDI of participants.
Time Frame
baseline and post- 4week intervention
Title
scores of the Northwick Park Neck Pain Questionnaire (NPQ)
Description
We will estimate the scores of NPQ of participants.
Time Frame
baseline and post- 4week intervention
Title
scores of Short-form McGill Pain Questionnaire(SF-MPQ)
Description
We will estimate the scores of SF-MPQ of participants.
Time Frame
baseline and post- 4week intervention
Other Pre-specified Outcome Measures:
Title
degree of Evaluation of the therapeutic effect
Description
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.
Time Frame
baseline and post- 4week intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Gao, Master
Phone
022-27432929
Ext
13920595861
Email
jennifergao1982@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
James Zhang, Master
Phone
022-27432929
Ext
13820590796
Email
james399@126.com
Facility Information:
Facility Name
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300193
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yucheng Wang, Bachelor
Phone
022-27432186
Ext
13752366330
Email
wangyucheng2014512@126.com
12. IPD Sharing Statement
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Study on the Early Warning and Treatment of Cervical Spondylosis of Cervical Type on Young People Based on the " Move Generate Yang " Theory
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