Cervical Spondylosis of Cervical Type Clinical Trial
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
| NCT number | NCT02199405 |
| Other study ID # | 13066 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | July 23, 2014 |
| Last updated | September 1, 2014 |
| Start date | September 2014 |
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.
| Status | Recruiting |
| Enrollment | 140 |
| Est. completion date | |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 15 Years to 18 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | Tianjin |
| Lead Sponsor | Collaborator |
|---|---|
| Wang Yucheng |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | degree of Evaluation of the therapeutic effect | 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. | baseline and post- 4week intervention | No |
| Primary | value of cervical curvature | We will examine the value of cervical curvature of participants at baseline and post- 4week intervention. | baseline and post- 4week intervention | No |
| Secondary | 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. | baseline and post- 4week intervention | No |
| Secondary | 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. | baseline and post- 4week intervention | No |
| Secondary | scores of the Neck Disability Index(NDI) | We will estimate the scores of NDI of participants. | baseline and post- 4week intervention | No |
| Secondary | scores of the Northwick Park Neck Pain Questionnaire (NPQ) | We will estimate the scores of NPQ of participants. | baseline and post- 4week intervention | No |
| Secondary | scores of Short-form McGill Pain Questionnaire(SF-MPQ) | We will estimate the scores of SF-MPQ of participants. | baseline and post- 4week intervention | No |