Shi-style Cervical Manipulations for Nonspecific Neck Pain: a Multi-center, Randomized, Controlled Clinical Trial
NCT ID: NCT05108610
Last Updated: 2021-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2021-11-01
2022-12-30
Brief Summary
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Detailed Description
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From 1999 to 2006, 534 patients with various types of degenerative spine instability diseases (except myelomyelitis) were treated by the project team, and the total effective rate of the "three steps and nine steps" in the treatment of clinical symptoms and signs of degenerative spine instability diseases was 91.76%. Through reviewing 60 cases of nerve root type of randomized controlled trials, 8 weeks after treatment, treatment group 30 cases (the whole neck three-step nine method), total effective rate 93.3%, control group total effective rate was 73.3% (cervical traction) (P \< 0.01), the treatment group in improving the neck shoulder pain, upper limb numbness, dizziness, tinnitus, brachial plexus pull test is better than that in control group (P \< 0.05), the clinical operation without adverse reaction.
Clinical studies have shown that the "Shi-style manipulations" have outstanding efficacy and high safety in the treatment of degenerative spinal instability diseases. The study intends to carry out a randomized, traction-controlled study in 5 tertiary hospital test centers, with patients with non-specific neck pain as the research object, using "Shi-style manipulations" and traction as intervention methods, and checking indicators and subjective effects through relevant instruments Indicators, quantitative verification of the mechanical parameters and biological effects of the "Shi-style manipulations", scientific evaluation of the efficacy and safety of the "Shi-style manipulations" in non-specific neck pain diseases.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Traction
6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks.
Cervical Traction control
6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks.
Shi-style manipulations
Shi-style manipulations is a cervical manipulation for cervical spondylosis.This manipulation is a kind of traditional Chinese massage and it can dredge the meridians. Patients are treated every day for 30 minutes. Seven times as one course and totally there are two courses. 3 times a week, once the other day（except the weekends）,30 minutes, 2 weeks.
Shi-style manipulations
Shi-style cervical manipulation is a spinal manipulation for cervical radiculopathy.It is a kind of traditional chinese massage and can dredge the meridian.Patients are treated every day for 30 minutes.Seven times at one course and totally there are two courses.3 times a week, once the other day（except the weekends）,30 minutes, 2 weeks.
Interventions
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Shi-style manipulations
Shi-style cervical manipulation is a spinal manipulation for cervical radiculopathy.It is a kind of traditional chinese massage and can dredge the meridian.Patients are treated every day for 30 minutes.Seven times at one course and totally there are two courses.3 times a week, once the other day（except the weekends）,30 minutes, 2 weeks.
Cervical Traction control
6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female between the ages of 18 and 65 (including 18 and 65);
* VAS score ≥30 mm;
* Sign the informed consent voluntarily.
Exclusion Criteria
* With cervical nerve compression or spinal cord compression symptoms and signs, MRI found spinal compression;
* The vertebral body was shifted, horizontally shifted \>3 mm forward, backward or laterally, and the adjacent intervertebral space had an Angle difference of \>11°;
* Patients with liver, kidney, hematopoietic system and other serious primary diseases, with a history of opioid analgesics, sedative and hypnotic drugs and alcohol abuse;
* Patients with osteoporosis, spinal tuberculosis, vertebral body malformation, malignant tumors and mental diseases;
* Pregnant women and lactating women;
* Unable to participate in the follow-up (for example, the plan of migration or long-distance relocation within half a year, no communication tools such as mobile phones, etc.), and the patients without the ability to participate in the half-year follow-up cannot read and write Chinese;
* received radio frequency, minimally invasive, ozone, small needle knife, manipulation, traction or closed treatment Within the last two weeks;
* Participating in other clinical trials related to cervical spondylosis.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Hospital
OTHER_GOV
Shenzhen Pingle Orthopaedic Hospital
UNKNOWN
Dongzhimen Hospital, Beijing
OTHER
Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Region
OTHER
Traditional Chinese Medicine Hospital of Ganzhou Nankang District
UNKNOWN
Shanghai University of Traditional Chinese Medicine
OTHER
Responsible Party
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Cui xuejun
Clinical Research Base of Traditional Chinese Medicine
Principal Investigators
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Yongjun Wan, Doctor of Medicine(M.D.)
Role: PRINCIPAL_INVESTIGATOR
Shanghai University of Traditional Chinese Medicine
Central Contacts
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Other Identifiers
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Nonspecific Neck Pain
Identifier Type: -
Identifier Source: org_study_id