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The modern interpretation and clinical application of the new pathogenesis theory of "Kidney deficiency and marrow atrophy" in discogenic low back pain

The modern interpretation and clinical application of the new pathogenesis theory of "Kidney deficiency and marrow atrophy" in discogenic low back pain

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025000790
Enrollment
Unknown
Registered
2025-04-21
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

discogenic low back pain

Interventions

RCT study: integrated Chinese and Western medicine treatment corhot:Western medicine treatment + oral Chinese medicine decoction or Chinese patent medicine
Cohort study: Western medicine treatment cohort:1) Western medicine: Celeoxib capsule (Udine Shi Yao Group Euyi Pharmaceutical Co. LTD. specification: 0.2g*30 capsules *1 bottle) 2) Usage and dosage:
RCT study: traditional Chinese medicine treatment cohort:Syndrome differentiation and treatment oral traditional Chinese medicine decoction or proprietary Chinese medicine
Cohort study: integrated Chinese and Western medicine treatment corhot:Western medicine treatment + oral Chinese medicine decoction or Chinese patent medicine
Cohort study: traditional Chinese medicine treatment cohort:Syndrome differentiation and treatment oral traditional Chinese medicine decoction or proprietary Chinese medicine
RCT study:Western medicine treatment cohort:1) Western medicine: Celeoxib capsule (Udine Shi Yao Group Euyi Pharmaceutical Co. LTD. specification: 0.2g*30 capsules *1 bottle) 2) Usage and dosage: 0.2g

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: To be included in this study participants must meet the following criteria: Meet the diagnostic criteria for Traditional Chinese Medicine (TCM) chronic low back pain and Western Medicine discogenic low back pain. Aged 18-60 years both male and female. VAS score for low back pain = 4. Voluntarily participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Participants who fall under any of the following circumstances will be excluded from this trial: 1) There are conditions such as lumbar spondylolysis lumbar spondylolisthesis lumbar disc herniation lumbar spinal stenosis and severe spinal stenosis Patients with column bending; 2) Individuals with organic lesions in the spine (such as fractures tuberculosis tumors ankylosing spondylitis etc.); 3) For those who have combined other serious primary diseases and complications in internal medicine such as severe liver or kidney disease strict measures should be taken Severe heart disease or poorly controlled hypertension diabetes serious gastrointestinal diseases or digestive system problems patient; 4) Patients with bleeding tendency; 5) Pregnant or lactating women; The RCT study added the following exclusion criteria: 1) Use traditional Chinese medicine such as "tonifying the kidneys and regulating the marrow" within 4 weeks; 2) Acupuncture and moxibustion or acupotomy and other invasive Chinese medicine treatment were performed within 1 week before treatment and local blocking treatment was performed within 3 weeks; 3) Use within 7 days prior to randomization or plan to use nonsteroidal anti-inflammatory drugs (acetaminophen) during the study period Except for tablets with a daily dose not exceeding 2000mg; 4) Use within 30 days or plan to use opioid or corticosteroid therapy during the study period (but only inhalation is required) Subjects treated with corticosteroids for asthma may be included; 5) Patients who are allergic to or have significant drug intolerance to the drugs used in this study; 6) Patients with a history of drug abuse; 7) Patients currently participating in other clinical trials; 8) The study suggests that there are other patients who are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
VAS;

Secondary

MeasureTime frame
MRI;JOA;Pittsburgh sleep quality index;the frequency of attacks and the duration of each episode;ODI;Efficient;Time of first relief of pain;Safety indicators (three routine liver and kidney function body temperature respiration heart rate blood pressure electrocardiogram);36-item Short-Form;adverse event;

Countries

China

Contacts

Public ContactChengliang Wu

Zhejiang Chinese Medical University

wcl@zcmu.edu.cn13175007769

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026