Clinical Effect of Long Round Needle

Not Applicable

Completed

• Conditions: Cervical Spondylotic Radiculopathy
• Interventions: Procedure: Filiform needle; Procedure: Long round needle

• Registration Number: NCT05587075
• Lead Sponsor: Zhanqing Xie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-10-31
• Study Completion: 2022-04-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-16
• Last Update Submitted: 2022-10-16
• Study First Posted: 2022-10-19
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Filiform needle	The control group was treated with filiform needle.
Observation group	Long round needle	The observation group was treated with long round needle.

Primary Outcome Measures

Name	Time	Method
Neck dysfunction index (NDI)	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.
McGill pain questionnaire (MPQ) score	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.
comprehensive assessment questionnaire (GQOL-74) scale	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.
interleukin-8 (IL-8) level	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.
interleukin-10 (IL-10) level	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.

Trial Locations

Locations (1)

Zhanqing; 🇨🇳 Baoding, Hebei, China