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Study on the Treatment of C/S of Qi Stagnation and Blood-stasis Type by Moving Cupping With Bloodletting

Primary Purpose

Cervical Spondylosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Massage treatment
Cupping
Bloodletting
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spondylosis focused on measuring Cervical Spondylosis of Qi Stagnation and Blood-stasis Type

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria 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. Exclusion criteria 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Experimental Group

    Control Group

    Arm Description

    Cupping and bloodletting therapy

    Massage treatment

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Measurement of cervical spine mobility
    Measure the angles of cervical spine flexion, extension, left flexion, right flexion, left rotation, and right rotation using a cervical spine mobility measuring instrument.
    Scoring of Traditional Chinese Medicine Syndrome
    Referring to the Guiding Principles for Clinical Research of New Chinese Medicine (Trial), the symptom grading of cervical spondylosis includes strong neck pain, limb numbness, dizziness, headache, limb paralysis, palpitations, insomnia, tinnitus, and chills; Score 0, 2, 4, and 6 points based on none, light, medium, and heavy, respectively. The total score is 0-54 points, and the lower the total score, the lighter the clinical symptoms.
    Adverse reactions
    Record the occurrence of adverse events during the patient's treatment, including the type and number of adverse reactions.

    Full Information

    First Posted
    September 20, 2023
    Last Updated
    October 19, 2023
    Sponsor
    Shanghai University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06093997
    Brief Title
    Study on the Treatment of C/S of Qi Stagnation and Blood-stasis Type by Moving Cupping With Bloodletting
    Official Title
    Study on the Treatment of Cervical Spondylosis of Qi Stagnation and Blood-stasis Type by Moving Cupping Combined With Bloodletting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai University of Traditional Chinese Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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
    Detailed Description
    In recent years, the incidence rate of cervical spondylosis has continued to rise. Among them, cervical spondylosis of qi stagnation and blood stasis type, mainly characterized by neck and shoulder pain, is mainly treated by activating blood to remove blood stasis, regulating qi and unblocking collaterals due to blood stasis and qi stagnation and blocked muscles and collaterals. Massage therapy is the most commonly used in clinical practice, but its maintenance time is short and clinical symptoms recur. How to remove stasis and prolong the time of blood circulation is the key to treatment. Walking cupping has the function of unblocking meridians and regulating qi and blood. Compared to massage, kneading, and pressing to stimulate acupoints, walking cupping also increases the scope of stimulation. If it is not clear, it will cause pain, while if it is clear, it will not cause pain. By pricking the meridians and releasing blood, it can activate the meridians, dispel blood stasis, and relieve pain. After cupping, pricking and bleeding can increase the amount of bleeding. The combination of the two can further alleviate symptoms such as neck and shoulder pain and stiffness in patients, and improve the therapeutic effect. Based on this, this project randomly divided 62 patients with cervical spondylosis of qi stagnation and blood stasis type into a control group and an experimental group. The control group received massage treatment, while the experimental group received cupping combined with bloodletting therapy. Using the Northwick Park Neck Pain Scale score as the primary outcome measure; Cervical mobility measurement, traditional Chinese medicine syndrome score, and adverse reactions are secondary outcome indicators. Objectively evaluate the efficacy of cupping combined with bloodletting puncture in the treatment of cervical spondylosis patients with qi stagnation and blood stasis, promote suitable techniques with traditional Chinese medicine characteristics for treating cervical spondylosis, and help cervical spondylosis patients recover their daily life and work abilities as soon as possible.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Spondylosis
    Keywords
    Cervical Spondylosis of Qi Stagnation and Blood-stasis Type

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    62 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    Cupping and bloodletting therapy
    Arm Title
    Control Group
    Arm Type
    Experimental
    Arm Description
    Massage treatment
    Intervention Type
    Other
    Intervention Name(s)
    Massage treatment
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Cupping
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Bloodletting
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The Northwick Park Neck Pain Questionnaire
    Description
    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.
    Time Frame
    Before treatment, 1 week after treatment, 4 weeks after treatment, and 1 month after the end of treatment
    Secondary Outcome Measure Information:
    Title
    Measurement of cervical spine mobility
    Description
    Measure the angles of cervical spine flexion, extension, left flexion, right flexion, left rotation, and right rotation using a cervical spine mobility measuring instrument.
    Time Frame
    Before treatment, 1 week after treatment, 4 weeks after treatment, and 1 month after the end of treatment
    Title
    Scoring of Traditional Chinese Medicine Syndrome
    Description
    Referring to the Guiding Principles for Clinical Research of New Chinese Medicine (Trial), the symptom grading of cervical spondylosis includes strong neck pain, limb numbness, dizziness, headache, limb paralysis, palpitations, insomnia, tinnitus, and chills; Score 0, 2, 4, and 6 points based on none, light, medium, and heavy, respectively. The total score is 0-54 points, and the lower the total score, the lighter the clinical symptoms.
    Time Frame
    Before treatment, 1 week after treatment, 4 weeks after treatment, and 1 month after the end of treatment
    Title
    Adverse reactions
    Description
    Record the occurrence of adverse events during the patient's treatment, including the type and number of adverse reactions.
    Time Frame
    Before treatment, 1 week after treatment, 4 weeks after treatment, and 1 month after the end of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria 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. Exclusion criteria 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MingLi Gao, Master
    Phone
    +8613917497734
    Email
    lilygao827@qq.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    YanYan Shang, Master
    Phone
    +8602164394141
    Email
    shqgywk@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Feng Xu, chief
    Organizational Affiliation
    Shanghai Qigong Institute
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data about the Northwick Park Neck Pain Questionnaire, Measurement of cervical spine mobility, Scoring of Traditional Chinese Medicine Syndrome and Adverse reactions
    IPD Sharing Time Frame
    Available after the end of the study, available for 20 years.
    IPD Sharing Access Criteria
    Contact the researcher to request.
    Citations:
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32947547
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    Jiang Q. The combination of cupping and scraping for the treatment of back myofasciitis. Massage and Rehabilitation Medicine June. 2015 (21): 18-19.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8173853
    Citation
    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.
    Results Reference
    background

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    Study on the Treatment of C/S of Qi Stagnation and Blood-stasis Type by Moving Cupping With Bloodletting

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