Clinical trial NCT02705131: Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy
Official title: Balance Chiropractic Therapy for Cervical Spondylotic Radiculopathy: a Randomized Parallel-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: Cervical radiculopathy
Balance chiropractic therapy
Lead sponsor: Shaanxi University of Chinese Medicine
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Scores as measured by the Visual Analog Scale
timeFrame: Three months
Secondary outcomes:
measure: cervical curvature as measured by Borden method
timeFrame: three months
measure: composite of functional status as measured by Neck Disability Index
timeFrame: three months
measure: Health Related Quality of Life as measured by SF-36
timeFrame: three months
Other outcomes:
Locations:
Study officials:
affiliation: Shaanxi university of TCM
name: Li Liu, Dr.
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.