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Evaluating the Efficacy and Safety of Internal Heat Needle versus Warm Needle Moxibustion for Lumbar Disc Herniation with Cold-Dampness Obstruction Pattern: A Randomized Controlled Trial Based on the Theory of "Puncturing with Heated Needle to Resolve Bi Syndrome"

Mechanisms of Internal Heat Needle in Treating Lumbar Disc Herniation with Cold-Dampness Obstruction: A Study Based on the "Heated Needle for Bi Syndrome" Theory

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002482
Enrollment
Unknown
Registered
2025-12-24
Start date
2025-02-22
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Lumbar Disc Herniation

Interventions

Acupuncture group:Standard acupuncture, once daily for 2 weeks.
Warm Acupuncture Group:Warm needle moxibustion therapy, once daily, for 2 weeks.
Internal Heat Needle Group:Internal heat needle therapy, 2 times per week, 4 times over 2 weeks.

Sponsors

The Traditional Chinese Medicine Department of the 900th Hospital, Logistics Support Force, People's Liberation Army.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the diagnostic criteria of Western medicine and the diagnostic criteria of Chinese medicine syndrome, specifically of the cold-dampness type, and are not candidates for surgery; (2) Individuals aged between 18 and 35 years who have a need for conservative treatment; (3) Patients who have not taken non-steroidal anti-inflammatory drugs (NSAIDs), hormones, or other Western medications in the past two weeks and have not used other treatment methods for this condition; (4) Patients with recurrent symptoms and a disease duration exceeding six months; (5) Patients who are conscious, can independently understand the educational materials, and are willing to undergo follow-up; (6) Individuals who have not participated in other drug clinical trials; (7) Volunteers who agree to participate in this study and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Abnormal vital signs; (2) Redness, swelling, heat, skin infection, or muscle necrosis at the treatment site; (3) Individuals with abnormal coagulation mechanisms; (4) Patients with severe damage to the cardiovascular, respiratory, digestive, immune, nervous, endocrine, or hematological systems; (5) Individuals with diabetes, skin ulcers that are slow to heal; individuals with hypertension that is difficult to control; pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Clinical efficacy;Visual Analog Scale (VAS) for Pain;JOA score;Oswestry Disability Index (ODI);TNF-a;IL-6;Surface Electromyography (AEMG);Surface Electromyography (sEMG) - Muscle Fiber (MF);Infrared thermal imaging technology;—

Countries

China

Contacts

Public ContactHuang Dong E

The Traditional Chinese Medicine Department of the 900th Hospital, Logistics Support Force, People's Liberation Army.

673738102@qq.com13600886358

Outcome results

None listed

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