Trial record 2 of 7 for:    Open Studies | "Fractures, Compression"

Efficacy Study of Acupuncture on Spinal Compression Fracture

This study is currently recruiting participants.
Verified February 2014 by Daegu Catholic University Medical Center
Sponsor:
Information provided by (Responsible Party):
Jin-Young, Chung, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier:
NCT01913587
First received: July 30, 2013
Last updated: February 2, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Spinal Compression Fracture
Device: Acupuncture
Procedure: Nerve block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Acupuncture on Spinal Compression Fracture in Patients Treated With Nerve Block

Resource links provided by NLM:


Further study details as provided by Daegu Catholic University Medical Center:

Primary Outcome Measures:
  • Visual analogue scale (VAS) [ Time Frame: Change from baseline to 5 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline to 5 weeks ] [ Designated as safety issue: No ]
    Evaluation will performed before treatment, after 3 week, and 5 week (2 weeks follow-up).

  • Oswestry Disability Index (ODI) [ Time Frame: Change from baseline to 5 weeks ] [ Designated as safety issue: No ]
    Evaluation will be performed before treatment, after 3 week, and 5 week (2 weeks follow-up).


Estimated Enrollment: 14
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01913587

Contacts
Contact: Jin-Young Chung, M.D,Ph.D +82 53 650 4505 jychung@cu.ac.kr

Locations
Korea, Republic of
Daegu Catholic University Medical Center Recruiting
Daegu, Kyungsangbukdo, Korea, Republic of
Sponsors and Collaborators
Daegu Catholic University Medical Center
Investigators
Principal Investigator: Jeong-Chul Seo, KMD, Ph.D Comprehensive and Intergrative Medicine Institute
Principal Investigator: Min-Ah Gwak, KMD, Ph.D Daegu Oriental Hospital of Daegu Haany University
Principal Investigator: Seong-Hoon Park, KMD Comprehensive and Integrative Medicine Insitute
  More Information

No publications provided

Responsible Party: Jin-Young, Chung, Department of anesthesiolgy, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier: NCT01913587     History of Changes
Other Study ID Numbers: CIMI-13-01-21
Study First Received: July 30, 2013
Last Updated: February 2, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Compression
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014