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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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ClinicalTrials.gov Identifier: NCT02199405
Recruitment Status : Unknown
Verified September 2014 by Wang Yucheng, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : July 24, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Wang Yucheng, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

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.


Condition or disease Intervention/treatment Phase
Cervical Spondylosis of Cervical Type Other: Massage of chiropractic and adjusting cervical curvature Other: Sishi Daoyin Other: conventional massage Other: Cervical traction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2014
Estimated Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic

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
Other: Massage of chiropractic and adjusting cervical curvature
Massage of chiropractic and adjusting cervical curvature, 10 minutes, three times one week for 4 weeks

Other: Sishi Daoyin
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
Other: conventional massage
Conventional massage , 15 minutes, three times one week for 4 weeks

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. scores of the Neck Disability Index(NDI) [ Time Frame: baseline and post- 4week intervention ]
    We will estimate the scores of NDI of participants.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199405


Contacts
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Contact: Jennifer Gao, Master 022-27432929 ext 13920595861 jennifergao1982@126.com
Contact: James Zhang, Master 022-27432929 ext 13820590796 james399@126.com

Locations
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China, Tianjin
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Recruiting
Tianjin, Tianjin, China, 300193
Contact: Yucheng Wang, Bachelor    022-27432186 ext 13752366330    wangyucheng2014512@126.com   
Sponsors and Collaborators
Wang Yucheng

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Responsible Party: Wang Yucheng, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02199405     History of Changes
Other Study ID Numbers: 13066
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: September 2014

Keywords provided by Wang Yucheng, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine:
Spondylosis, Massage Therapy, Exercise Therapy ,Treatment Efficacy

Additional relevant MeSH terms:
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Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases