Clinical trial NCT05587075: Clinical Effect of Long Round Needle
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spondylotic Radiculopathy
Lead sponsor: The No. 2 Hospital of Baoding
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test in the clinical effect of long round needle in the treatment of cervical spondylotic radiculopathy, and analyze its safety and its influence on pain and functional recovery. The main question it aims to answer is whether long round needle therapy for patients with cervical spondylotic radiculopathy is effective and safe. Participants will be selected as the research objects. They will randomly divided into control group (n = 49) and observation group (n = 49). The control group was treated with filiform needle, and the observation group was treated with long round needle. Researchers will compare the two groups to see the differences on the therapeutic effect, safety, Neck dysfunction index (NDI), pain score (McGill pain questionnaire, MPQ), quality of life (Generic Quality of Life Inventory-74, GQOL-74), and levels of inflammatory factors.


Eligibility criteria: 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.

Primary outcomes:
measure: Neck dysfunction index (NDI)
timeFrame: Before treament
measure: Neck dysfunction index (NDI)
timeFrame: Through study completion, an average of 1 year and 10 months
measure: McGill pain questionnaire (MPQ) score
timeFrame: Before treament
measure: McGill pain questionnaire (MPQ) score
timeFrame: Through study completion, an average of 1 year and 10 months
measure: comprehensive assessment questionnaire (GQOL-74) scale
timeFrame: Before treament
measure: comprehensive assessment questionnaire (GQOL-74) scale
timeFrame: Through study completion, an average of 1 year and 10 months
measure: interleukin-8 (IL-8) level
timeFrame: Before treament
measure: interleukin-8 (IL-8) level
timeFrame: Through study completion, an average of 1 year and 10 months
measure: interleukin-10 (IL-10) level
timeFrame: Before treament
measure: interleukin-10 (IL-10) level
timeFrame: Through study completion, an average of 1 year and 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baoding
country: China
facility: Zhanqing
state: Hebei
Study officials:
References: