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Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy

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ClinicalTrials.gov Identifier: NCT02705131
Recruitment Status : Unknown
Verified March 2016 by Feng Yang, Shaanxi University of Chinese Medicine.
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Feng Yang, Shaanxi University of Chinese Medicine

Brief Summary:
The purpose of this study is to evaluate the therapeutic effect and safety of the Balance Chiropractic Therapy(BCT) on Cervical Spondylotic Radiculopathy and to investigate the mechanism of which this efficacy is achieved.

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Device: Balance Chiropractic Therapy Device: Traction Therapy Not Applicable

Detailed Description:
The investigators propose a multi center randomized, parallel-controlled trial to evaluate the efficacy and safety of the balance chiropractic therapy for CSR. Participants aged 18 to 65, who are in conformity with the diagnostic criteria of CSR and the pain score regarding visual analog scales is more than 4 points and less than 8 points, will be included and randomly allocated into two groups: test group and control group. Participants in the test group will be treated with the balance chiropractic therapy, while the control group will receive the traction therapy. The primary outcome is pain severity (measured with a visual analogue scale (VAS)). Secondary outcomes will include cervical curvature (measured by Borden index), a composite of functional status(measured by Neck Disability Index ,NDI), individual patients health status(evaluated by SF-36 health survey ), and adverse events as reported in the trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy: a Randomized Parallel-controlled Trial
Study Start Date : April 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic

Arm Intervention/treatment
Experimental: Balance Chiropractic Therapy(BCT)
patients are in the sitting position and receive the Balance Chiropractic Therapy(BCT) .1)Balancing tendon-regulation;2) Balancing osteopathy;3) Balance collaterals-dredging.The patients will received BCT 1 time every other day, 20min each time. a total of 10 times in 20 days.
Device: Balance Chiropractic Therapy
patients are in the sitting position and receive the following treatments.1)Balancing tendon-regulation;2) Balancing osteopathy;3) Balance collaterals-dredging.

Active Comparator: Traction Therapy(TT)
patients will receive the Traction Therapy(TT):The patient is sitting and wearing a cloth bag occipital jaw traction comfortable,with head bending forward about 10-15 degrees in comfort.The weight for traction of cervical spondylosis is started at 3 kg, and gradually increased to the maximum weight not more than 6kg according to the standard of 0.5kg each time. The treatment is performed 30 minutes a time per day, 10 times as a course,a total of 2 courses.
Device: Traction Therapy
patients will received the traction therapy.The patient is sitting and wearing a cloth bag occipital jaw traction comfortable,with head bending forward about 10-15 degrees in comfort.The weight for traction of cervical spondylosis is started at 3 kg, and gradually increased to the maximum weight not more than 6kg according to the standard of 0.5kg each time. The treatment is performed 30 minutes a time per day, 10 times as a course,a total of 2 courses.




Primary Outcome Measures :
  1. Pain Scores as measured by the Visual Analog Scale [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. cervical curvature as measured by Borden method [ Time Frame: three months ]
  2. composite of functional status as measured by Neck Disability Index [ Time Frame: three months ]
  3. Health Related Quality of Life as measured by SF-36 [ Time Frame: three months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who are in conformity with the diagnostic criteria of CSR;
  • Aged between18 and 65 years old;
  • The pain score regarding visual analog scales is more than 4 points and less than 8 points;
  • sign the informed consent.

Exclusion Criteria:

  • Subjects will be excluded if they have disorders such as vague diagnosis of acute spinal cord injury or acute spinal cord inflammation,or cervical vertigo symptom and checking for abnormal changes on transcranial doppler(TCD).
  • Subjects will also be excluded if they have combined liver, kidney, hematopoietic system, endocrine system, cardiovascular system, nervous system and other severe primary disease,or fractures,osteoarticular tuberculosis, osteomyelitis, bone tumor, severe osteoporosis,or mental disabilities,
  • A weak body can not withstand the stimulation of the balance chiropractic therapy .
  • Individuals who have acute infectious disease, stomach or duodenal ulcer with acute perforation,or treated areas with severe skin damage or skin diseases.
  • Subjects that have received surgical treatment or neck injury, or radiofrequency of cervical intervertebral disc, or minimally invasive, or ozone, or acupuncture and moxibustion, or other manipulations or block therapy within two weeks
  • Lactating or pregnant patients.
  • Subjects who are participating in other clinical trials related to cervical spondylosis.

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): NCT02705131


Contacts
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Contact: Zhu Liu, Dr. 0086-29-33320876 393541065@qq.com
Contact: Feng Yang, Dr. 0086-029-33347009 yangfengdudu@163.com

Sponsors and Collaborators
Feng Yang
Investigators
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Study Chair: Li Liu, Dr. Shaanxi university of TCM

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Feng Yang, Principal Investigator, Shaanxi University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT02705131     History of Changes
Other Study ID Numbers: SXUCM-018
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Feng Yang, Shaanxi University of Chinese Medicine:
Cervical radiculopathy
Balance chiropractic therapy

Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases