NCT01909284

Brief Summary

This study is being conducted to investigate the effectiveness and safety of acupuncture for alleviating pain of spondylosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
unknown

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 18, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 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

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

July 18, 2013

Last Update Submit

February 2, 2014

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale(VAS)

    This outcome will measure changes in the participant's level of low back pain.

    Change from baseline to 5 weeks

Secondary Outcomes (4)

  • Short form McGill pain questionnaire

    Chagnes from baseline to 5 weeks

  • Oswestry Disability Index

    Changes from baseline to 5 weeks

  • Present pain intensity(PPI)

    Changes from baseline to 5 weeks

  • Pain vision

    Chagnes from baseline to 5 weeks

Other Outcomes (1)

  • Safety

    After the initiation of acupuncture, 2 weeks, and 4 weeks

Study Arms (2)

Acupuncture & Epidural nerve block

EXPERIMENTAL

acupuncture plus epidural block

Device: AcupunctureProcedure: Epidural nerve block

Epidural nerve block

ACTIVE COMPARATOR

epidural block alone

Procedure: Epidural nerve block

Interventions

AcupunctureDEVICE

* BL40, BL60, ST36, GB34 : bilaterally, manual acupuncture. * Two points on 1st bladder meridian nearest location of back pain : bilaterally, electrical acupuncture.

Acupuncture & Epidural nerve block
Epidural nerve blockPROCEDURE

Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).

Acupuncture & Epidural nerve blockEpidural nerve block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 65 years
  • Meyerding Grade I-II spondylolisthesis
  • Low back pain of at least 1-year duration
  • Follow-up possible during the clinical trial
  • Written informed consent voluntarily

You may not qualify if:

  • Cauda equina syndrome, persistently exacerbated symptoms, progressive neurologic signs (sensory or motor changes)
  • Previous spine surgery
  • Senile dementia, impaired cognitive function or other cerebral disease, severe psychiatric or psychological disorders
  • Severe, concomitant disease (neuromuscular scoliosis, neurodegenerative disease)
  • All contraindications to corticosteroid injection (e.g., insulin-dependent diabetes)
  • Alcohol/drug abuse
  • Significant renal or hepatic disease
  • Pregnant, lactating or planning a pregnancy
  • Hypersensitive reaction to acupuncture treatment
  • Inability to comprehend or express oneself in the Korean language
  • An individual deemed to be ineligible by a physician
  • Refusal to participate in the trial or to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, Kyungsangbukdo, South Korea

RECRUITING

Related Publications (1)

  • Lee HJ, Seo JC, Kwak MA, Park SH, Min BM, Cho MS, Shin I, Jung JY, Roh WS. Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial. Trials. 2014 Apr 2;15:105. doi: 10.1186/1745-6215-15-105.

    PMID: 24693959DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

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

Central Study Contacts

Un-Suk Noh, M.D,Ph.D

CONTACT

+82 53 650 4054usno@cu.ac.kr

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 18, 2013

First Posted

July 26, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

KR(1)