Efficacy Study of Acupuncture on Spinal Compression Fracture

N/ACompletedNCT01913587

Daegu Catholic University Medical Center14 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Compression Fracture

Interventions

AcupunctureDEVICE

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).

Nerve blockPROCEDURE

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).

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Daegu Catholic University Medical Center

Daegu, Kyungsangbukdo, South Korea

Outcomes

Primary Outcomes

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).

Time frame: Change from baseline to 5 weeks

Secondary Outcomes

Short form McGill pain questionnaire

Evaluation will performed before treatment, after 3 week, and 5 week (2 weeks follow-up).

Time frame: 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).

Time frame: Change from baseline to 5 weeks

Data from ClinicalTrials.gov

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