NCT01913587

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 22, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

July 30, 2013

Last Update Submit

December 7, 2021

Conditions

Spinal Compression Fracture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Short form McGill pain questionnaire

    Change from baseline to 5 weeks

  • Oswestry Disability Index (ODI)

    Change from baseline to 5 weeks

Study Arms (2)

Acupuncture & Nerve block

EXPERIMENTAL

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: AcupunctureProcedure: Nerve block

Nerve block

ACTIVE COMPARATOR

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

Procedure: Nerve block

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).

Acupuncture & Nerve block
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).

Acupuncture & Nerve blockNerve block

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • weeks from onset or more
  • Follow-up possible during the clinical trial
  • Written informed consent voluntarily

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, Kyungsangbukdo, South Korea

Location

MeSH Terms

Interventions

Acupuncture TherapyNerve Block

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of anesthesiolgy

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 1, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 22, 2021

Record last verified: 2021-12

Locations

KR(1)