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Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy

Primary Purpose

Cervical Radiculopathy

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Balance Chiropractic Therapy

Traction Therapy

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Cervical radiculopathy, Balance chiropractic therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Balance Chiropractic Therapy(BCT)

Traction Therapy(TT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain Scores as measured by the Visual Analog Scale

Secondary Outcome Measures

cervical curvature as measured by Borden method

composite of functional status as measured by Neck Disability Index

Health Related Quality of Life as measured by SF-36

Full Information

NCT ID

NCT02705131

First Posted

February 28, 2016

Last Updated

March 9, 2016

Sponsor

Feng Yang

1. Study Identification

Unique Protocol Identification Number

NCT02705131

Brief Title

Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy

Official Title

Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy: a Randomized Parallel-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Feng Yang

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Radiculopathy

Keywords

Cervical radiculopathy, Balance chiropractic therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Balance Chiropractic Therapy(BCT)

Arm Type

Experimental

Arm Description

Arm Title

Traction Therapy(TT)

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Balance Chiropractic Therapy

Intervention Description

patients are in the sitting position and receive the following treatments.1)Balancing tendon-regulation;2) Balancing osteopathy;3) Balance collaterals-dredging.

Intervention Type

Device

Intervention Name(s)

Traction Therapy

Intervention Description

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 Measure Information:

Title

Pain Scores as measured by the Visual Analog Scale

Time Frame

Three months

Secondary Outcome Measure Information:

Title

cervical curvature as measured by Borden method

Time Frame

three months

Title

composite of functional status as measured by Neck Disability Index

Time Frame

three months

Title

Health Related Quality of Life as measured by SF-36

Time Frame

three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhu Liu, Dr.

Phone

0086-29-33320876

393541065@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Feng Yang, Dr.

Phone

0086-029-33347009

yangfengdudu@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Liu, Dr.

Organizational Affiliation

Shaanxi university of TCM

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26640708

Citation

Campa-Moran I, Rey-Gudin E, Fernandez-Carnero J, Paris-Alemany A, Gil-Martinez A, Lerma Lara S, Prieto-Baquero A, Alonso-Perez JL, La Touche R. Comparison of Dry Needling versus Orthopedic Manual Therapy in Patients with Myofascial Chronic Neck Pain: A Single-Blind, Randomized Pilot Study. Pain Res Treat. 2015;2015:327307. doi: 10.1155/2015/327307. Epub 2015 Nov 10.

Results Reference

background

PubMed Identifier

16924193

Citation

Tanaka Y, Kokubun S, Sato T, Ozawa H. Cervical roots as origin of pain in the neck or scapular regions. Spine (Phila Pa 1976). 2006 Aug 1;31(17):E568-73. doi: 10.1097/01.brs.0000229261.02816.48.

Results Reference

result

PubMed Identifier

1834753

Citation

Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15. Erratum In: J Manipulative Physiol Ther 1992 Jan;15(1):followi.

Results Reference

result

PubMed Identifier

12047701

Citation

Carlin JB, Doyle LW. Sample size. J Paediatr Child Health. 2002 Jun;38(3):300-4. doi: 10.1046/j.1440-1754.2002.00855.x. No abstract available.

Results Reference

result

PubMed Identifier

17347239

Citation

Binder AI. Cervical spondylosis and neck pain. BMJ. 2007 Mar 10;334(7592):527-31. doi: 10.1136/bmj.39127.608299.80. No abstract available.

Results Reference

result

PubMed Identifier

27770801

Citation

Yang F, Li WX, Liu Z, Liu L. Balance chiropractic therapy for cervical spondylotic radiculopathy: study protocol for a randomized controlled trial. Trials. 2016 Oct 22;17(1):513. doi: 10.1186/s13063-016-1644-2.

Results Reference

derived

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Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy

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