- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05587075
Clinical Effect of Long Round Needle
Clinical Effect and Safety Analysis of Liu Yingmin Long Round Needle in the Treatment of Cervical Spondylotic Radiotelegraphy and Its Effect on Pain and Functional Recovery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hebei
-
Baoding, Hebei, China, 071051
- Zhanqing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
(1) meet the efficacy criteria for disease certificate diagnosis of Traditional Chinese medicine[4]In the category of "Arthralgia Syndrome" and "Stiff neck", the main diseases: numbness and pain in the shoulder, neck and upper limbs, secondary diseases: unfavorable neck movement, hard, heavy head, thin coating, reddish tongue; (2) cervical X-ray shows hyperplasia of the vertebral body; (3) the patient or family members are informed and signed consent.
Exclusion Criteria:
(1) patients with severe periarthritis of shoulder and mixed cervical spondylosis; (2) spinal canal space-occupying lesions and cervical spine tumors; (3) serious immune system diseases and infectious diseases; (4) liver and kidney insufficiency; (5) cardiovascular and cerebrovascular diseases; (6) mental diseases or medical history; (6) patients with incomplete clinical data and poor compliance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
The control group was treated with filiform needle.
|
A needle treatment: guide patients take lying or sitting, keep relaxed, select Jingjiaji Point, Fengchi Point, Jianjing Point, Tianzhu Point, Houxi point, Hegu Point, Waiguan Point, preoperative, marker points, conventional disinfection, application specification of 0.35mmx50mm disposable sterile acupuncture needle, in the marker quick needle subcutaneous, slow needle to feel acid swelling feeling, keep needle 30min, once a day, last 5d for 1 course, a total of 4 courses of treatment.
|
Experimental: Observation group
The observation group was treated with long round needle.
|
Long round needle treatment: mark tendon lesions, take 3-5 tendon lesion points for needle point, after injection of 0.5% lidocaine 1mL, local anesthesia, to hold long round needle, slowly hierarchical detection to tendon lesion points, patients feel acid, hemp, swelling feeling is appropriate, to close method line knot treatment: straight to tendon lesions point surface, scraping, to remove the surface adhesion.
Do not cross the superficial surface of the clavicle, sternocleidomastoid muscle deep surface, gentle action.
After the needle was released, the pinhole was covered with a disposable dressing, bandaged for 2d, once a week, once for 1 course, and for a total of 4 courses of treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck dysfunction index (NDI)
Time Frame: Before treament
|
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points.
The score value was inversely related to the patient's cervical spine function.
|
Before treament
|
Neck dysfunction index (NDI)
Time Frame: Through study completion, an average of 1 year and 10 months
|
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points.
The score value was inversely related to the patient's cervical spine function.
|
Through study completion, an average of 1 year and 10 months
|
McGill pain questionnaire (MPQ) score
Time Frame: Before treament
|
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points.
The score value was inversely related to the patient's cervical spine function.
|
Before treament
|
McGill pain questionnaire (MPQ) score
Time Frame: Through study completion, an average of 1 year and 10 months
|
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points.
The score value was inversely related to the patient's cervical spine function.
|
Through study completion, an average of 1 year and 10 months
|
comprehensive assessment questionnaire (GQOL-74) scale
Time Frame: Before treament
|
Using the comprehensive assessment questionnaire (GQOL-74) scale, mainly including psychological function, social function, physical function and other items, the score value is positively correlated with the quality of life of patients.
|
Before treament
|
comprehensive assessment questionnaire (GQOL-74) scale
Time Frame: Through study completion, an average of 1 year and 10 months
|
Using the comprehensive assessment questionnaire (GQOL-74) scale, mainly including psychological function, social function, physical function and other items, the score value is positively correlated with the quality of life of patients.
|
Through study completion, an average of 1 year and 10 months
|
interleukin-8 (IL-8) level
Time Frame: Before treament
|
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
|
Before treament
|
interleukin-8 (IL-8) level
Time Frame: Through study completion, an average of 1 year and 10 months
|
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
|
Through study completion, an average of 1 year and 10 months
|
interleukin-10 (IL-10) level
Time Frame: Before treament
|
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
|
Before treament
|
interleukin-10 (IL-10) level
Time Frame: Through study completion, an average of 1 year and 10 months
|
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
|
Through study completion, an average of 1 year and 10 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HBaoding
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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