Efficacy Study of Acupuncture on Spinal Compression Fracture

Study Overview
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Brief Summary
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This study is to investigate the effectiveness of acupuncture for alleviating pain from Spinal Compression Fracture in Patients Treated with Nerve Block.

Detailed Description
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Spinal compression fracture is mainly caused by trauma, furthermore, in old age, osteoporosis increases the risk of spinal compression fracture. Nerve block is effective for the management of pain from inflammation or nerve root stimulation from spinal compression fracture. As one of alternative interventions, acupuncture is effective for controlling spinal compression fracture. This study aims to investigate that combination with acupuncture and nerve block may relieve spinal compression fracture-related pain versus nerve block alone.

Official Title
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Efficacy and Safety of Acupuncture on Spinal Compression Fracture in Patients Treated With Nerve Block

Conditions
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Spinal Compression Fracture

Intervention / Treatment
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* Device: Acupuncture
* Procedure: Nerve block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vertebral compression fracture by trauma or osteoporosis Minimum 15% height loss of vertebrae Patient diagnosed with x-ray or computed tomography (CT) or magnetic resonance image (MRI) Visual analogue scale (VAS) score of 5 or more Age over 50 2 weeks from onset or more Follow-up possible during the clinical trial Written informed consent voluntarily Exclusion Criteria: Within 2 weeks from onset Pathological fracture due to malignancy/myeloma, osteomyelitis Major retropulsion of bony segments into the spinal canal Bone metabolic disease Significant renal or hepatic disease Hypersensitive reaction to acupuncture treatment Senile dementia, impaired cognitive function or other cerebral disease, severe psychiatric or psychological disorders Alcohol/drug abuse

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture & Nerve block<br>Acupuncture will be performed 3 times per week, total 9 sessions, during 3 weeks. Epidural nerve block and medial branch block will be performed once per week, total 3 sessions, during 3 weeks. | Device: Acupuncture<br>* Acupuncture points are ST36, GB34 (bilateral), BL60 (bilateral), BL40 (bilateral), and 2 Back-su points (bilateral). Back-su points are selected as close as possible to pain region. Electroacupuncture will be performed at only 2 Back-su points (bilateral).<br>Procedure: Nerve block<br>* Epidural nerve block uses the mixture (10ml) of dexamethasone (10 mg) and bupivacaine (10 mg) dissolved in saline solution. Medial branch block uses mepivacaine (10 mg).<br>|
| Active Comparator: Nerve block<br>Epidural nerve block and medial branch block will be performed once per week, total 3 sessions, during 3 weeks. | Procedure: Nerve block<br>* Epidural nerve block uses the mixture (10ml) of dexamethasone (10 mg) and bupivacaine (10 mg) dissolved in saline solution. Medial branch block uses mepivacaine (10 mg).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) | The patients will be required to document 100mm pain VAS, where '0' represents 'no pain' and '100', 'unbearable pain'. The change of pain will be reported by comparing the mean VAS before treatment, after 3 week, and 5 week (2 weeks follow-up). | Change from baseline to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short form McGill pain questionnaire | Evaluation will performed before treatment, after 3 week, and 5 week (2 weeks follow-up). | Change from baseline to 5 weeks | 
| Oswestry Disability Index (ODI) | Evaluation will be performed before treatment, after 3 week, and 5 week (2 weeks follow-up). | Change from baseline to 5 weeks |