Efficacy and Safety of Acupuncture on Spinal Compression Fracture in Patients Treated With Nerve Block
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Visual analogue scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Visual analogue scale (VAS)
Time Frame: 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 Outcomes
- Oswestry Disability Index (ODI)(Change from baseline to 5 weeks)
- Short form McGill pain questionnaire(Change from baseline to 5 weeks)
Investigators
Jin Yong Jung
Department of anesthesiolgy
Daegu Catholic University Medical Center