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Efficacy Study of Acupuncture on Spinal Compression Fracture

Primary Purpose

Spinal Compression Fracture

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acupuncture
Nerve block
Sponsored by
Daegu Catholic University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Compression Fracture

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Daegu Catholic University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture & Nerve block

Nerve block

Arm Description

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.

Epidural nerve block and medial branch block will be performed once per week, total 3 sessions, during 3 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Short form McGill pain questionnaire
Evaluation will performed before treatment, after 3 week, and 5 week (2 weeks follow-up).
Oswestry Disability Index (ODI)
Evaluation will be performed before treatment, after 3 week, and 5 week (2 weeks follow-up).

Full Information

First Posted
July 30, 2013
Last Updated
December 7, 2021
Sponsor
Daegu Catholic University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01913587
Brief Title
Efficacy Study of Acupuncture on Spinal Compression Fracture
Official Title
Efficacy and Safety of Acupuncture on Spinal Compression Fracture in Patients Treated With Nerve Block
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daegu Catholic University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Compression Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture & Nerve block
Arm Type
Experimental
Arm Description
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.
Arm Title
Nerve block
Arm Type
Active Comparator
Arm Description
Epidural nerve block and medial branch block will be performed once per week, total 3 sessions, during 3 weeks.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Nerve block
Intervention Description
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).
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
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 Outcome Measure Information:
Title
Short form McGill pain questionnaire
Description
Evaluation will performed before treatment, after 3 week, and 5 week (2 weeks follow-up).
Time Frame
Change from baseline to 5 weeks
Title
Oswestry Disability Index (ODI)
Description
Evaluation will be performed before treatment, after 3 week, and 5 week (2 weeks follow-up).
Time Frame
Change from baseline to 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Chul Seo, KMD, Ph.D
Organizational Affiliation
Comprehensive and Intergrative Medicine Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Min-Ah Gwak, KMD, Ph.D
Organizational Affiliation
Daegu Oriental Hospital of Daegu Haany University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seong-Hoon Park, KMD
Organizational Affiliation
Comprehensive and Integrative Medicine Insitute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daegu Catholic University Medical Center
City
Daegu
State/Province
Kyungsangbukdo
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Acupuncture on Spinal Compression Fracture

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