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Acupuncture combined with Chinese herbal medicine for discogenic low back pain: study protocol for a multi-center, randomized controlled trial

Acupuncture combined with Chinese herbal medicine for discogenic low back pain: study protocol for a multi-center, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082428
Enrollment
Unknown
Registered
2024-03-28
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-27

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

Acupuncture group:true acupuncture & herbal placebo & capsules placebo
Chinese herbal medicine group:Chinese herbal medicine granules & sham acupuncture & capsules placebo
Acupuncture combined with Chinese herbal medicine:true acupuncture & Chinese herbal medicine granules & capsules placebo
Positive drug control group:celecoxib capsules & sham acupuncture & granules placebo

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: ? Simultaneously meeting the diagnostic criteria of chronic low back pain in traditional Chinese medicine and the diagnostic criteria of discogenic low back pain in Western medicine; ? Age greater than or equal to 18 years old, regardless of gender; ? Visual Analog Scale (VAS) = 4 cm; ? Voluntarily participate in this experiment and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) with lumbar spondylolysis, lumbar spondylolisthesis, lumbar disc herniation, spinal canal stenosis, or severe scoliosis; (2) presence of organic spinal diseases such as fractures, tuberculosis, tumors, ankylosing spondylitis, etc.; (3) concurrent severe primary medical conditions and complications, such as severe liver or kidney disease, severe heart disease or poorly controlled hypertension, diabetes, severe gastrointestinal diseases, or digestive system problems; (4) patients with bleeding tendencies; (5) pregnant or lactating women; (6) patients who are needle-phobic, intolerant to acupuncture, or refuse acupuncture treatment; (7) patients allergic to the medications used in this study or with apparent drug intolerance; (8) patients with history of substance abuse; (9) patients currently enrolled in other clinical trials; (10) patients deemed by the investigators as unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
pain intensity;

Secondary

MeasureTime frame
lumbar pressure pain threshold;Oswestry Disability Index (ODI) scores;Hospital Anxiety and Depression Scale (HADS) scores;Pittsburgh Sleep Quality Index (PSQI) scores;36-item Short-Form Health Survey;

Countries

China

Contacts

Public ContactTian Guihua

Dongzhimen Hospital, Beijing University of Chinese Medicine

rosetgh@163.com+86 10 8401 7758

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026