NCT06093997

Brief Summary

The goal of this Clinical randomized controlled trial is to evaluate the therapeutic effect of cupping combined with bloodletting in the treatment of cervical spondylosis of qi stagnation and blood stasis type. The main question it aims to answer is: How to remove stasis and prolong the time of promoting blood circulation. Participants will adopt the combination of cupping and bloodletting therapy.Researchers will compare massage treatment to see if the combination of cupping and bloodletting puncture is more effective in treating cervical spondylosis of qi stagnation and blood stasis type

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 28, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2025

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

September 20, 2023

Last Update Submit

April 26, 2026

Conditions

Keywords

Cervical Spondylosis of Qi Stagnation and Blood-stasis Type

Outcome Measures

Primary Outcomes (1)

  • The Northwick Park Neck Pain Questionnaire

    Including clinical symptoms (degree and duration of neck pain, etc.) and quality of life (sleep time, impact on reading and watching TV, impact on social activities, etc.), a total of 9 items, with a total score of 32-36 points. The final score is converted into a percentage system, and the higher the score, the worse the cervical condition.

    Before treatment, 1 week after treatment, 4 weeks after treatment, and 1 month after the end of treatment

Secondary Outcomes (3)

  • Measurement of cervical spine mobility

    Before treatment, 1 week after treatment, 4 weeks after treatment, and 1 month after the end of treatment

  • Scoring of Traditional Chinese Medicine Syndrome

    Before treatment, 1 week after treatment, 4 weeks after treatment, and 1 month after the end of treatment

  • Adverse reactions

    Before treatment, 1 week after treatment, 4 weeks after treatment, and 1 month after the end of treatment

Study Arms (2)

Experimental Group

EXPERIMENTAL

Cupping and bloodletting therapy

Other: CuppingOther: Bloodletting

Control Group

EXPERIMENTAL

Massage treatment

Other: Massage treatment

Interventions

The patient sits upright and the neck naturally relaxes. The doctor uses techniques such as pressing and kneading to relax the soft tissues of the neck, and massages points such as FengMen, FengChi, JingJiaji, JianJing,Tianzong and so on. The focus is on using muscle relaxation techniques around the soft tissues of spasms and pain areas to relax the patient's neck and shoulders. All procedures were performed from mild to severe, once a week for 15 minutes each time, for a total of 4 weeks of treatment.

Control Group
CuppingOTHER

Use a 4-5cm diameter suction cupping for cupping. The treatment area is coated with glycerol, and the cupping is aspirated and adsorbed on the skin. The cupping is slowly pushed along the patient's neck, along the urinary bladder channel of Foot-Taiyang and governor's meridians from top to bottom, repeating back and forth 9 times. Once a week, for a total of 4 weeks of treatment.

Experimental Group

the doctor takes JianZhongShu, one on the left and one on the right, with a total of 2 acupoints. After disinfecting with 75% alcohol cotton balls, the patient is quickly pricked 5 times with a blood collection needle, and cupping is performed at the needle hole. After 5 minutes, remove the jar, wipe the blood clean, and disinfect the needle hole. Once a week, for a total of 4 weeks of treatment.

Experimental Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who meet the diagnostic criteria (Traditional Chinese medicine diagnosis conforms to the diagnostic criteria for cervical spondylosis of qi and blood stasis type in the "Guiding Principles for Clinical Research of Traditional Chinese Medicine New Drugs". Western medicine diagnosis adopts the diagnostic criteria for cervical spondylosis developed at the "Third National Symposium on Cervical Spondylosis" held in April 2008 at Dongfang Hospital Affiliated to Tongji University.);
  • The course of the disease is more than 3 months;
  • Gender unlimited ④ Age 18-80 years old; ⑤ No history of neck and shoulder surgery; ⑥ Those who have not received relevant treatment in the past month; ⑦ Those who voluntarily participate in this study and sign an informed consent form.

You may not qualify if:

  • Head and neck injuries;
  • Patients with a tendency to bleed;
  • Pregnant and lactating women;
  • Concomitant with serious primary diseases such as heart, cerebrovascular disease, liver, kidney, etc;
  • Individuals with severe mental illness or cognitive impairment;
  • Individuals with acute infection or local skin damage due to local trauma; ⑦ Patients with infectious diseases transmitted through blood; ⑧ Those who cannot persist in receiving treatment according to the prescribed time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Outpatient Department of Shanghai Qigong Research Institute

Shanghai, China

Location

Related Publications (17)

  • Cervical Spondylosis Professional Committee of the Chinese Rehabilitation. Medical Association Guidelines for Diagnosis, Treatment and Rehabilitation of Cervical Spondylosis [S]: Beijing: Cervical Spondylosis Professional Committee of the Chinese Rehabilitation Medical Association, 2010.

    BACKGROUND
  • Jin Y. The clinical research progress of traditional Chinese medicine characteristic therapy in the treatment of cervical spondylosis. Chinese folk therapy. 2017. 25 (09): 103-104.

    BACKGROUND
  • Lian L, Zhang S. Clinical observation on the treatment of vertebral artery type cervical spondylosis with heat sensitive moxibustion combined with bloodletting. Journal of Modern Integrated Traditional Chinese and Western Medicine. 2018. 27 (31): 3468-3470.

    BACKGROUND
  • Chen L, Li M, Fan L, Zhu X, Liu J, Li H, Xu Z, Chen J, Liang Z, Liu Z, Feng L, Chen X, He Q, Chen X, Ou A, He J, Ma R, Ning B, Jiang L, Li S, Fu W. Optimized acupuncture treatment (acupuncture and intradermal needling) for cervical spondylosis-related neck pain: a multicenter randomized controlled trial. Pain. 2021 Mar 1;162(3):728-739. doi: 10.1097/j.pain.0000000000002071.

    PMID: 32947547BACKGROUND
  • Wu P, Wang J, Wang W, Gu J, Wu Z. Study on the Optimization of Acupuncture and Bleeding Analgesia Schemes for Cervical Spondylosis of Qi Stagnation and Blood Stasis Type. Chinese Journal of Basic Traditional Chinese Medicine. 2018. 24 (11): 1582-1585.

    BACKGROUND
  • Hai Q, Zhao L. Clinical observation on the treatment of cervical spondylosis of vertebral artery type with cupping and bloodletting therapy of Mongolian medicine combined with acupuncture and moxibustion. Chinese Journal of Ethnic Medicine. 2020.26 (08): 28-29.

    BACKGROUND
  • Yang X. Observation on therapeutic effect of Chinese massage combined with acupuncture and moxibustion on cervical spondylotic radiculopathy. Chinese folk therapy. 2014. 22 (07): 26.

    BACKGROUND
  • Luo G, Tang Z. Observation on the therapeutic effect of moving cupping combined with stasis needle technique on lumbar fasciitis. Journal of Practical Traditional Chinese Medicine. 2015. 31 (11): 1044.

    BACKGROUND
  • Jiang Q. The combination of cupping and scraping for the treatment of back myofasciitis. Massage and Rehabilitation Medicine June. 2015 (21): 18-19.

    BACKGROUND
  • Peng T, Gong H, Hu S, Zhou C, Xie G, Xiong J. Clinical observation on the treatment of neck shoulder syndrome with scraping combined with cupping therapy. Shanghai acupuncture and moxibustion Journal. 2016. 35 (06): 713-715.

    BACKGROUND
  • Jiang M, Peng T. The combination of meridian scraping and cupping therapy for the treatment of neck dorsalis myofascitis. Journal of Traditional Chinese Medicine. 2022. 37 (01): 197-200.

    BACKGROUND
  • Li H, Ma F, Zhang W, Zhao N, Hai X, Wang J. Clinical study on the treatment of nerve root cervical spondylosis of qi stagnation and blood stasis type with phased differentiation and massage therapy. Chinese Journal of Traditional Chinese Medicine. 2017. 35 (04): 939-942.

    BACKGROUND
  • Hu Y, Yang J, Li L. Progress in the treatment of vertebral artery type cervical spondylosis with acupuncture, moxibustion and massage. Hebei Medicine. 2015. 21 (08): 1532-1534.

    BACKGROUND
  • Ma Z, Fu A, Wang Y, Chen Z. The therapeutic effect of acupuncture combined with bloodletting therapy on cervical spondylotic radiculopathy and its impact on pain and blood viscosity. National Medical Forum. 2019. 34 (01): 23-24.

    BACKGROUND
  • Huang F, Wang H, Sun C, Wang L, Yin J, Zhang Q. Acupuncture and push combined with bloodletting therapy for treating 35 cases of cervical spondylosis with qi stagnation and blood stasis. Liaoning Journal of Traditional Chinese Medicine. 2019. 46 (01): 144-147.

    BACKGROUND
  • Peng T, Wan G, Shan R. Scraping combined with cupping for the treatment of 180 cases of neck shoulder syndrome. Modern Distance Education of Traditional Chinese Medicine in China. 2014. 12(07): 68-69.

    BACKGROUND
  • Leak AM, Cooper J, Dyer S, Williams KA, Turner-Stokes L, Frank AO. The Northwick Park Neck Pain Questionnaire, devised to measure neck pain and disability. Br J Rheumatol. 1994 May;33(5):469-74. doi: 10.1093/rheumatology/33.5.469.

    PMID: 8173853BACKGROUND

MeSH Terms

Conditions

Spondylosis

Interventions

Cupping TherapyBloodletting

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhlebotomyPunctures

Study Officials

  • Feng Xu, chief

    Shanghai Qigong Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Doctor

Study Record Dates

First Submitted

September 20, 2023

First Posted

October 23, 2023

Study Start

February 28, 2024

Primary Completion

May 7, 2025

Study Completion

May 7, 2025

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

This plan has not been approved by the Clinical Ethics Committee.

Locations