NCT02199405

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

September 3, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

July 23, 2014

Last Update Submit

September 1, 2014

Conditions

Keywords

Spondylosis, Massage Therapy, Exercise Therapy ,Treatment Efficacy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • range of motion of cervical vertebra

    baseline and post- 4week intervention

  • value of Surface Electromyography of neck muscles

    baseline and post- 4week intervention

  • scores of the Neck Disability Index(NDI)

    baseline and post- 4week intervention

  • scores of the Northwick Park Neck Pain Questionnaire (NPQ)

    baseline and post- 4week intervention

  • scores of Short-form McGill Pain Questionnaire(SF-MPQ)

    baseline and post- 4week intervention

Other Outcomes (1)

  • degree of Evaluation of the therapeutic effect

    baseline and post- 4week intervention

Study Arms (2)

massage and Sishi Daoyin

EXPERIMENTAL

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 curvatureOther: Sishi Daoyin

conventional massage and cervical traction

ACTIVE COMPARATOR

Conventional massage , 15 minutes, three times one week for 4 weeks Cervical traction , 15 minutes, three times one week for 4 weeks

Other: conventional massageOther: Cervical traction

Interventions

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

massage and Sishi Daoyin

Sishi Daoyin, practicing during 9-11am, once a day for 4 weeks

massage and Sishi Daoyin

Conventional massage , 15 minutes, three times one week for 4 weeks

conventional massage and cervical traction
Also known as: Cervical traction , 15 minutes, three times one week for 4 weeks
conventional massage and cervical traction

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300193, China

RECRUITING

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Jennifer Gao, Master

CONTACT

James Zhang, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Study Record Dates

First Submitted

July 23, 2014

First Posted

July 24, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Last Updated

September 3, 2014

Record last verified: 2014-09

Locations