Cervical Spondylosis of Cervical TypeNCT02199405
Study on the Early Warning and Treatment of Cervical Spondylosis of Cervical Type on Young People Based on the " Move Generate Yang " Theory
A study testing Massage of chiropractic and adjusting cervical curvature, Sishi Daoyin and conventional massage in people with Cervical Spondylosis of Cervical Type, run by Wang Yucheng at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Cervical Spondylosis of Cervical Type
- What is being tested?
- Massage of chiropractic and adjusting cervical curvature, Sishi Daoyin and conventional massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
Yucheng Wang, Bachelor, 022-27432186 ext. 13752366330, wangyucheng2014512@126.com
About this study
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.
Read the 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.
- Conditions
- Cervical Spondylosis of Cervical Type
- Being tested
- Massage of chiropractic and adjusting cervical curvature, Sishi Daoyin, conventional massage, Cervical traction
- Keywords
- Spondylosis, Massage Therapy, Exercise Therapy ,Treatment Efficacy
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage of chiropractic and adjusting cervical curvatureOther
Massage of chiropractic and adjusting cervical curvature, 10 minutes, three times one week for 4 weeks
Sishi DaoyinOther
Sishi Daoyin, practicing during 9-11am, once a day for 4 weeks
conventional massageOther
Conventional massage , 15 minutes, three times one week for 4 weeks
Cervical tractionOther
Also called Cervical traction , 15 minutes, three times one week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Massage of chiropractic and adjusting cervical curvature; Other: 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 Receives: Other: conventional massage; Other: Cervical traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
value of cervical curvature
We will examine the value of cervical curvature of participants at baseline and post- 4week intervention.
Measured: baseline and post- 4week intervention
Secondary outcomes (5)
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.
Measured: baseline and post- 4week intervention
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.
Measured: baseline and post- 4week intervention
scores of the Neck Disability Index(NDI)
We will estimate the scores of NDI of participants.
Measured: baseline and post- 4week intervention
scores of the Northwick Park Neck Pain Questionnaire (NPQ)
We will estimate the scores of NPQ of participants.
Measured: baseline and post- 4week intervention
scores of Short-form McGill Pain Questionnaire(SF-MPQ)
We will estimate the scores of SF-MPQ of participants.
Measured: baseline and post- 4week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spondylosis of Cervical TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Yucheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Yucheng, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199405
- Sponsor's protocol ID
- 13066
- Status last verified
- Sep 2014
- First submitted
- 23 Jul 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02199405
- Acronym / sponsor ID
- 13066
- Conditions
- Cervical Spondylosis of Cervical Type
- Keywords
- Spondylosis, Massage Therapy, Exercise Therapy ,Treatment Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Wang YuchengUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| massage and Sishi Daoyin | Experimental | Other: Massage of chiropractic and adjusting cervical curvature, Other: Sishi DaoyinMassage 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 |
| conventional massage and cervical traction | Active comparator | Other: conventional massage, Other: Cervical tractionConventional massage , 15 minutes, three times one week for 4 weeks Cervical traction , 15 minutes, three times one week for 4 weeks |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage of chiropractic and adjusting cervical curvatureMassage of chiropractic and adjusting cervical curvature, 10 minutes, three times one week for 4 weeks | Other | massage and Sishi Daoyin |
| Sishi DaoyinSishi Daoyin, practicing during 9-11am, once a day for 4 weeks | Other | massage and Sishi Daoyin |
| conventional massageConventional massage , 15 minutes, three times one week for 4 weeks | Other | conventional massage and cervical traction |
| Cervical tractionAlso: Cervical traction , 15 minutes, three times one week for 4 weeks | Other | conventional massage and cervical traction |
Primary outcome
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.
5 secondary outcomes
range of motion of cervical vertebra
Time frame: baseline and post- 4week intervention
value of Surface Electromyography of neck muscles
Time frame: baseline and post- 4week intervention
scores of the Neck Disability Index(NDI)
Time frame: baseline and post- 4week intervention
scores of the Northwick Park Neck Pain Questionnaire (NPQ)
Time frame: baseline and post- 4week intervention
scores of Short-form McGill Pain Questionnaire(SF-MPQ)
Time frame: baseline and post- 4week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage of chiropractic and adjusting cervical curvature, Sishi Daoyin and conventional massage in people with Cervical Spondylosis of Cervical Type, run by Wang Yucheng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Gao, Master (022-27432929 ext. 13920595861, jennifergao1982@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
value of cervical curvature (time frame: baseline and post- 4week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.