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Research on the Construction and Validation of the Risk Prediction Model for Residual Low Back Pain after Osteoporotic Vertebral Compression Fractures (OVCFs) Surgery and the Efficacy Evaluation of Traditional Chinese Medicine Intervention

Research on the Construction and Validation of the Risk Prediction Model for Residual Low Back Pain after Osteoporotic Vertebral Compression Fractures (OVCFs) Surgery and the Efficacy Evaluation of Traditional Chinese Medicine Intervention

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000169
Enrollment
Unknown
Registered
2025-01-25
Start date
2024-12-01
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Osteoporotic vertebral compression fractures

Interventions

Traditional Chinese medicine treatment group:Anti-osteoporosis Therapy plus Traditional Chinese Medicine Treatment (1) Anti-osteoporosis treatment: Take Calcium Carbonate D3 Tablets, 600 mg, once a da
and Calcitriol Soft Capsules, 25 micrograms (µg), twice a day (bid). (2) Administer orally the modified Liuwei Dihuang Decoction (from Key to Therapeutics of Children's Diseases). The continuous medic
Western medicine treatment group:Anti-osteoporosis Therapy plus Western Medicine Treatment (1) Anti-osteoporosis treatment: Take Calcium Carbonate D3 Tablets, 600 mg, once a day (qd)
and Calcitriol Soft Capsules, 25 micrograms (µg), twice a day (bid). (2) Administer Alendronate Sodium Enteric-coated Tablets, 70 mg, once a week (1/w). The continuous medication period is 4 weeks.

Sponsors

Beijing Hepingli Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Treated with Percutaneous Vertebroplasty (PVA); (2) Still having residual low back pain after surgery, with a Visual Analogue Scale (VAS) score of = 4 points on the 1st day after surgery; (3) Being diagnosed as the syndrome of liver-kidney yin deficiency according to traditional Chinese medicine syndrome differentiation; (4) Postoperative X-ray or CT confirming good dispersion of bone cement and no clinically significant leakage; (5) Imaging examinations confirming no new fractures after surgery; (6) Having good compliance, voluntarily cooperating with the treatment, and personally signing the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with pathological vertebral fractures caused by reasons such as tumors and infectious diseases; (2) Patients with severe allergic constitution; (3) Patients who are unwilling to take traditional Chinese medicine.

Design outcomes

Primary

MeasureTime frame
VAS point;

Secondary

MeasureTime frame
ODI point;Expression levels of the BTMs;Bone density;Number of analgesic medication;Traditional Chinese medicine syndrome points;

Countries

China

Contacts

Public ContactWenlong Li

Beijing Hepingli Hospital

liwenlongbucm@163.com+86 132 6998 6015

Outcome results

None listed

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