Study on the Early Warning and Treatment of Cervical Spondylosis of Cervical Type on Young People Based on the " Move Generate Yang " Theory

September 1, 2014 updated by: Wang Yucheng

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

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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tianjin
      • Tianjin, Tianjin, China, 300193
        • Recruiting
        • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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:
  • Cervical traction , 15 minutes, three times one week for 4 weeks

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.
baseline and post- 4week intervention

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.
baseline and post- 4week intervention
value of Surface Electromyography of neck muscles
Time Frame: baseline and post- 4week intervention
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
scores of the Neck Disability Index(NDI)
Time Frame: baseline and post- 4week intervention
We will estimate the scores of NDI of participants.
baseline and post- 4week intervention
scores of the Northwick Park Neck Pain Questionnaire (NPQ)
Time Frame: baseline and post- 4week intervention
We will estimate the scores of NPQ of participants.
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.
baseline and post- 4week intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of Evaluation of the therapeutic effect
Time Frame: baseline and post- 4week intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 24, 2014

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

September 1, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

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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