Clinical trial NCT06093997: 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
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Spondylosis
Keywords: Cervical Spondylosis of Qi Stagnation and Blood-stasis Type
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Northwick Park Neck Pain Questionnaire
timeFrame: Before treatment, 1 week after treatment, 4 weeks after treatment, and 1 month after the end of treatment
Secondary outcomes:
measure: Measurement of cervical spine mobility
timeFrame: Before treatment, 1 week after treatment, 4 weeks after treatment, and 1 month after the end of treatment
measure: Scoring of Traditional Chinese Medicine Syndrome
timeFrame: Before treatment, 1 week after treatment, 4 weeks after treatment, and 1 month after the end of treatment
measure: Adverse reactions
timeFrame: Before treatment, 1 week after treatment, 4 weeks after treatment, and 1 month after the end of treatment
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Medical Outpatient Department of Shanghai Qigong Research Institute
Study officials:
affiliation: Shanghai Qigong Institute
name: Feng Xu, chief
role: STUDY_DIRECTOR
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