Efficacy Study of Acupuncture on Spinal Compression Fracture

Not Applicable

Completed

• Conditions: Spinal Compression Fracture
• Interventions: Device: Acupuncture; Procedure: Nerve block

• Registration Number: NCT01913587
• Lead Sponsor: Daegu Catholic University Medical Center

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-08-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture & Nerve block	Acupuncture	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.
Acupuncture & Nerve block	Nerve block	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.
Nerve block	Nerve block	Epidural nerve block and medial branch block will be performed once per week, total 3 sessions, during 3 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).

Trial Locations

Locations (1)

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Kyungsangbukdo, Korea, Republic of