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
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
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Spondylosis of Cervical Type
Keywords: Spondylosis, Massage Therapy, Exercise Therapy ,Treatment Efficacy
Lead sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 140
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: value of cervical curvature
timeFrame: baseline and post- 4week intervention
Secondary outcomes:
measure: range of motion of cervical vertebra
timeFrame: baseline and post- 4week intervention
measure: value of Surface Electromyography of neck muscles
timeFrame: baseline and post- 4week intervention
measure: scores of the Neck Disability Index(NDI)
timeFrame: baseline and post- 4week intervention
measure: scores of the Northwick Park Neck Pain Questionnaire (NPQ)
timeFrame: baseline and post- 4week intervention
measure: scores of Short-form McGill Pain Questionnaire(SF-MPQ)
timeFrame: baseline and post- 4week intervention
Other outcomes:
measure: degree of Evaluation of the therapeutic effect
timeFrame: baseline and post- 4week intervention
Locations:
city: Tianjin
country: China
facility: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
Study officials:
References: