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Cervical RadiculopathyNCT02705131

Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy

A study testing Balance Chiropractic Therapy and Traction Therapy in people with Cervical Radiculopathy, run by Feng Yang.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cervical Radiculopathy
What is being tested?
Balance Chiropractic Therapy and Traction Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
No sites listed yet
Study dates
Apr 2016to Jul 2017
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Zhu Liu, Dr. contact

0086-29-33320876

393541065@qq.com

Feng Yang, Dr. contact

0086-029-33347009

yangfengdudu@163.com

About this study

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

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.

Read the 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.

Being tested
Balance Chiropractic Therapy, Traction Therapy
Keywords
Cervical radiculopathy, Balance chiropractic therapy
Medical subject headings
Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT02705131
Study groupRoleWhat they receive
Balance Chiropractic Therapy(BCT)Experimentalpatients 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.
Receives: Device: Balance Chiropractic Therapy
Traction Therapy(TT)Active comparatorpatients 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.
Receives: Device: Traction Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Scores as measured by the Visual Analog Scale

    Measured: Three months

Secondary outcomes (3)

  1. cervical curvature as measured by Borden method

    Measured: three months

  2. composite of functional status as measured by Neck Disability Index

    Measured: three months

  3. Health Related Quality of Life as measured by SF-36

    Measured: three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJul 2017 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

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
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02705131
Sponsor's protocol ID
SXUCM-018
Status last verified
Mar 2016
First submitted
28 Feb 2016
Last updated
10 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26640708

  • 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.

    PubMed 16924193

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

    PubMed 1834753

  • 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.

    PubMed 12047701

  • 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.

    PubMed 17347239

  • 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.

    PubMed 39188412

  • 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.

    PubMed 27770801

Questions about this trial

What is this clinical trial studying?

A study testing Balance Chiropractic Therapy and Traction Therapy in people with Cervical Radiculopathy, run by Feng Yang.

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 7 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 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

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 Zhu Liu, Dr. (0086-29-33320876, 393541065@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Scores as measured by the Visual Analog Scale (time frame: Three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02705131, which also lists 7 linked publications.

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 10 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.

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