Clinical trial NCT05108610: Shi-style Cervical Manipulations for Nonspecific Neck Pain: a Multi-center, Randomized, Controlled Clinical Trial
Official title: Shi-style Cervical Manipulations for Nonspecific Neck Pain: a Multi-center, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nonspecific Neck Pain
Keywords: Randomized controlled study；nonspecific neck pain；Shi-style manipulations；Mechanical parameters
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
name: Shenzhen Pingle Orthopaedic Hospital
name: Dongzhimen Hospital, Beijing
name: Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Region
name: Traditional Chinese Medicine Hospital of Ganzhou Nankang District
First posted: 2021-11-05
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: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Spinal instability diseases have a high prevalence and great harm. The research on how to prevent and treat degenerative spinal instability diseases has become a hot spot in the international academic community, and it is also an important research content in the field of "population and health" in my country. 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.

Detailed description: Spinal diseases are listed as the second most serious diseases in the world's top ten Diseases released by WHO. With the rapid pace of life, the aging of the population and the increase in chronic strain, the incidence of degenerative spinal instability diseases remains high and medical expenses increase.

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.

Eligibility criteria: Inclusion Criteria:

* The diagnosis is non-specific neck pain;
* 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:

* Have received surgical treatment or neck trauma for cervical spondylosis in the past;
* 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.

Primary outcomes:
measure: Musculoskeletal ultrasound
timeFrame: changes from baseline at 2 weeks
measure: Visual Analogue scale，(VAS)
timeFrame: changes from baseline at 2 weeks
measure: pressure pain threshold
timeFrame: changes from baseline at 2 weeks
measure: Musculoskeletal ultrasound
timeFrame: changes from baseline at 1 month
measure: Visual Analogue scale，(VAS)
timeFrame: changes from baseline at 1 month
measure: pressure pain threshold
timeFrame: changes from baseline at 1 month
measure: Musculoskeletal ultrasound
timeFrame: changes from baseline at 3 months
measure: Visual Analogue scale，(VAS)
timeFrame: changes from baseline at 3 months
measure: pressure pain threshold
timeFrame: changes from baseline at 3 months
Secondary outcomes:
measure: Neck Disabilitv Index， (NDI)
timeFrame: changes from baseline at 2 weeks
measure: the MOS item short from health survey，(SF-36)
timeFrame: changes from baseline at 2 weeks
measure: Cervical range of motion
timeFrame: changes from baseline at 2 weeks
measure: Neck Disabilitv Index， (NDI)
timeFrame: changes from baseline at 1 month
measure: the MOS item short from health survey，(SF-36)
timeFrame: changes from baseline at 1 month
measure: Cervical range of motion
timeFrame: changes from baseline at 1 month
measure: Neck Disabilitv Index， (NDI)
timeFrame: changes from baseline at 3 months
measure: the MOS item short from health survey，(SF-36)
timeFrame: changes from baseline at 3 months
measure: Cervical range of motion
timeFrame: changes from baseline at 3 months
Other outcomes:
measure: The doctor of traditional Chinese medicine syndrome
timeFrame: changes from baseline at 2 weeks
measure: The doctor of traditional Chinese medicine syndrome
timeFrame: changes from baseline at 1 month
measure: The doctor of traditional Chinese medicine syndrome
timeFrame: changes from baseline at 3 months
Locations:
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Yongjun Wan, Doctor of Medicine(M.D.)
role: PRINCIPAL_INVESTIGATOR
References: