NCT02705131

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

1.2 years

First QC Date

February 28, 2016

Last Update Submit

March 9, 2016

Conditions

Cervical Radiculopathy

Keywords

Cervical radiculopathyBalance chiropractic therapy

Outcome Measures

Primary Outcomes (1)

  • Pain Scores as measured by the Visual Analog Scale

    Three months

Secondary Outcomes (3)

  • cervical curvature as measured by Borden method

    three months

  • composite of functional status as measured by Neck Disability Index

    three months

  • Health Related Quality of Life as measured by SF-36

    three months

Study Arms (2)

Balance Chiropractic Therapy(BCT)

EXPERIMENTAL

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

Traction Therapy(TT)

ACTIVE COMPARATOR

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

Interventions

Balance Chiropractic TherapyDEVICE

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

Balance Chiropractic Therapy(BCT)
Traction TherapyDEVICE

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.

Traction Therapy(TT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 26640708BACKGROUND

  • 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.

    PMID: 16924193RESULT

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

    PMID: 1834753RESULT

  • 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.

    PMID: 12047701RESULT

  • 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.

    PMID: 17347239RESULT

  • Li W, Chang Y, Feng Q, Cheng Y, Yin J, Sun Y, Yang F. Balance chiropractic therapy for cervical spondylotic radiculopathy: A randomized controlled trial. Contemp Clin Trials Commun. 2024 Jul 14;41:101323. doi: 10.1016/j.conctc.2024.101323. eCollection 2024 Oct.

    PMID: 39188412DERIVED

  • 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.

    PMID: 27770801DERIVED

MeSH Terms

Conditions

Radiculopathy

Interventions

Traction

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Li Liu, Dr.

    Shaanxi university of TCM

    STUDY CHAIR

Central Study Contacts

Zhu Liu, Dr.

CONTACT

0086-29-33320876393541065@qq.com

Feng Yang, Dr.

CONTACT

0086-029-33347009yangfengdudu@163.com

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
Principal Investigator

Study Record Dates

First Submitted

February 28, 2016

First Posted

March 10, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

March 10, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share