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The efficacy of electroacupuncture in the treatment of thoracolumbar compression fractures in menopausal women, a prospective, two-arm, single-center randomized controlled trial protocol.

Prospective, double arm, single center randomized controlled trial of the efficacy of electroacupuncture in the treatment of postmenopausal women's thoracolumbar compressibility fractures and the promotion of joint function recovery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071614
Enrollment
Unknown
Registered
2023-05-19
Start date
2023-05-29
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Compression fracture

Interventions

Electroacupuncture Group:The patient will be in a prone position and receive electroacupuncture treatment of BL23, BL25, BL40, BL60, GV20, KI3 and GB34. Deqi will connect the electroacupuncture device
Medication Group:1. Alendronate: 70mg per week, fasted overnight, taken with water in the morning after waking up. 2. Salmon calcitonin: 200 International Units (IU) or 1 spray into one nostril per da

Sponsors

Zhaoqing medical college
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
49 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Menopausal women aged 49-70 years. 2. sign an informed consent form. 3. meet the diagnostic criteria for primary thoracolumbar osteoporotic compression fracture: (1) Medical history: risk factors: smoking, alcohol consumption, oestrogen deficiency, dietary calcium or vitamin D deficiency, Asian, advanced age, etc. (2) Physical examination: closed fist percussion along the spine, sudden and sharp pain felt by the patient, pain when the patient rotates the body, etc. (3) Imaging: edema on sagittal T2-weighted magnetic resonance (MR) images or on a short inversion recovery sequence combined with a sagittal T1-weighted sequence. (4) Ancillary examinations: Bone mineral density measured by dual-energy X-ray absorptiometry (DXA) with a T value = -2.5 SD. 4. A1 fractures in the AOSpine classification of thoracolumbar spine injuries, compression injuries, wedge compression or embedment fractures with a single endplate fracture, not involving the posterior wall of the vertebral body. 5. Thoracolumbar spine injury classification and severity (TLICS) score = 4.

Exclusion criteria

Exclusion criteria: 1. Unstable compression fractures that should be treated by surgery. 2. With severe scoliosis with a Cobb angle > 30°. 3. With combination of other systemic diseases leading to secondary osteoporosis 4. Suffering from severe allergic, infectious skin diseases. 5. Suffering from bleeding disorders (e.g. thrombocytopenic purpura, haemophilia, etc.) 6. Suffering from severe cognitive impairment and unable to cooperate with treatment. 7. Requiring long-term oral medication that affects bone metabolism, such as glucocorticoids 8. With neurological complications. 9. Having a metal implant in the body, such as a pacemaker.

Design outcomes

Primary

MeasureTime frame
Bone mineral density;Visual analogue scoring;

Secondary

MeasureTime frame
Oswestry dysfunction index;QUALEFFO-41;

Countries

China

Contacts

Public ContactHuang Yong

Southern Medical University College of Traditional Chinese Medicine

nanfanglihuang@163.com+86 137 1918 9644

Outcome results

None listed

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