Observation on the Curative Effect of Acupuncture At Sensitized Points on Gallbladder Meridian in the Treatment of Neck Type Cervical Spondylopathy

NCT06847945 | Not Yet Recruiting

• 1 other identifier: ZSLL-KY-2023-040-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the changes of acupoint sensitization characteristics of patients with Neck Type Cervical Spondylopathy through Gallbladder meridian observe the curative effect of acupuncture intervention and optimize the clinical diagnosis and treatment plan of acupuncture treatment of Neck Type Cervical Spondylopathy

Conditions

Cervical Spondylopathy

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  The visual Analogue Scale (VAS) ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function of the Cervical. Participants were asked to evaluate their current pain, and the pain nature was marked by X on the line above. 0 was classified as painless and 10 was classified as severe pain. The higher the score, the more obvious the pain.

  Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up

Secondary Outcomes (5)

• musculoskeletal ultrasound detection of cervical

  Before the start of treatment, immediately after the end of the third treatment

• Pressure pain threshold

  Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up

• The Neck Disability Index

  Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up

• Cervical range of motion scale

  Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up

• The 12 items Short Form Health Survey

  Before the start of treatment, immediately after the end of the third treatment, and four weeks after follow-up

Study Arms (2)

Non-meridian，non-acupoint group

SHAM COMPARATOR

Procedure: Sham acupuncture

Acupoint sensitization group

EXPERIMENTAL

Procedure: Acupuncture

Interventions

Sham acupuncture PROCEDURE

Patients in the non-meridian and non-acupoint group received sham acupuncture treatment at the position 2cm apart from the sensitized acupoint, once every other day for 30min each time, a total of 3 times for 1 week.

Non-meridian，non-acupoint group

Acupuncture PROCEDURE

Patients in acupoint sensitization group were treated with pseudoacupuncture at the sensitized points once every other day for 30min each time, a total of 3 times for 1 week.

Acupoint sensitization group

Eligibility Criteria

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

You may qualify if:

• Meeting the diagnostic criteria of Neck Type Cervical Spondylopathy.
• Age 18 to 65 years old gender is not limited.
• Clear awareness good compliance willing to cooperate with the study and accept the experimental arrangement.
• Physical examination may or may not be accompanied by positive signs of the musculoskeletal system (including limited motor function local tender points etc.).
• The visual analogue Scale (VAS) score was more than 3 points and less than 7 points (ranging from 0 to 10 points).
• Informed consent and sign informed consent.

You may not qualify if:

• Under 18 years of age or over 65 years of age;
• weeks before the start of the experiment the relevant treatment of the disease or the use of relevant therapeutic drugs;
• Patients with other types of cervical spondylosis (cervical radiculopathy vertebral artery type cervical spondylosis cervical myelopathy sympathetic cervical spondylosis) or with other serious organic diseases and patients with neck and shoulder pain caused by non-neck diseases;
• Patients with cardiovascular and cerebrovascular liver kidney digestive system blood system and other serious life-threatening primary diseases or suffering from hemorrhagic diseases or skin diseases or pregnant or lactating women or have a history of cardiac pacemaker implantation;
• Previous history of neck surgery or neck fracture;
• Persons with confusion mental disorder or cognitive impairment;
• The skin at the test site has scars redness swelling heat and pain that affect the test result.

Sponsors & Collaborators

• LiChaoran: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medicine University

Hangzhou, 310000, China

Location

Related Publications (1)

• Li C, Wang J, Shao X, Wu Y, Qu X, Cai J, He L, Yu L, Xu R, Xia Y, Wang R, Zhang L, Qiu Y. Acupuncture at Sensitized Acupoints versus Sham Acupuncture for Neck-Type Cervical Spondylosis: Study Protocol for a Randomized Controlled Trial. J Pain Res. 2025 Dec 23;18:6963-6976. doi: 10.2147/JPR.S548317. eCollection 2025.

  PMID: 41458188 DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Chaoran Li

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  STUDY CHAIR

Central Study Contacts

Chaoran Li

CONTACT

15557137527; crwd44@163.com

Study Design

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

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 26, 2025
• Study Start: March 5, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

CN (1)