Spinal Compression Fracture
Conditions
Brief summary
This study is to investigate the effectiveness of acupuncture for alleviating pain from Spinal Compression Fracture in Patients Treated with Nerve Block.
Detailed description
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.
Interventions
DEVICEAcupuncture
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).
PROCEDURENerve block
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).
Sponsors
Daegu Catholic University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale (VAS) | Change from baseline to 5 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short form McGill pain questionnaire | Change from baseline to 5 weeks | Evaluation will performed before treatment, after 3 week, and 5 week (2 weeks follow-up). |
| Oswestry Disability Index (ODI) | Change from baseline to 5 weeks | Evaluation will be performed before treatment, after 3 week, and 5 week (2 weeks follow-up). |
Countries
South Korea
Outcome results
None listed