Clinical Effect of Long Round Needle

NCT05587075 | Completed

• 1 other identifier: HBaoding
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spondylotic Radiculopathy

Outcome Measures

Primary Outcomes (10)

• Neck dysfunction index (NDI)

  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)

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

Control group

ACTIVE COMPARATOR

The control group was treated with filiform needle.

Procedure: Filiform needle

Observation group

EXPERIMENTAL

The observation group was treated with long round needle.

Procedure: Long round needle

Interventions

Filiform needle PROCEDURE

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.

Control group

Long round needle PROCEDURE

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.

Observation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Zhanqing Xie: lead

Study Sites (1)

Zhanqing

Baoding, Hebei, 071051, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 19, 2022
• Study Start: January 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: April 30, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

CN (1)