Efficacy Study of Acupuncture on Spinal Compression Fracture

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

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

Study Overview

• Status: Completed
• Conditions: Spinal Compression Fracture
• Intervention / Treatment: Device: Acupuncture; Procedure: 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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyungsangbukdo
    • Daegu, Kyungsangbukdo, Korea, Republic of
      • Daegu Catholic University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture & 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.	Device: Acupuncture; 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).; Procedure: Nerve 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).
Active Comparator: Nerve block; Epidural nerve block and medial branch block will be performed once per week, total 3 sessions, during 3 weeks.	Procedure: Nerve 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center
• Investigators: Principal Investigator: Jeong-Chul Seo, KMD, Ph.D, Comprehensive and Intergrative Medicine Institute; Principal Investigator: Seong-Hoon Park, KMD, Comprehensive and Integrative Medicine Insitute

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: July 30, 2013
• First Posted (Estimate): August 1, 2013

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Compression
• Other Study ID Numbers: CIMI-13-01-21