Efficacy Study of Acupuncture to Treat Spinal Pain

February 2, 2014 updated by: Un-Suk, Noh (PhD), Daegu Catholic University Medical Center

Pilot Study of Efficacy and Safety of Acupuncture on Patient With Spinal Pain Due to Spondylolithesis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is being conducted at the Daegu Catholic University Medical Center. Enrolled participants will be randomized into two groups : acupuncture treatment plus epidural block and epidural block alone.

This trial will include treatments during 3 weeks, and then follow up after 2 weeks. Participants will have acupuncture treatments of three times per week and epidural block of once per week. All examinations and treatments will be provided free of charge. Compared with epidural block group, acupuncture plus epidural block group will give more effectiveness for alleviate pain caused by lumbar spondylosis.

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture & Epidural nerve block
acupuncture plus epidural block
Device: Acupuncture
  • BL40, BL60, ST36, GB34 : bilaterally, manual acupuncture.
  • Two points on 1st bladder meridian nearest location of back pain : bilaterally, electrical acupuncture.
Procedure: Epidural nerve block
Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).
Active Comparator: Epidural nerve block
epidural block alone
Procedure: Epidural nerve block
Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale(VAS)
Time Frame: Change from baseline to 5 weeks
This outcome will measure changes in the participant's level of low back pain.
Change from baseline to 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short form McGill pain questionnaire
Time Frame: Chagnes from baseline to 5 weeks
Chagnes from baseline to 5 weeks
Oswestry Disability Index
Time Frame: Changes from baseline to 5 weeks
Changes from baseline to 5 weeks
Present pain intensity(PPI)
Time Frame: Changes from baseline to 5 weeks
Changes from baseline to 5 weeks
Pain vision
Time Frame: Chagnes from baseline to 5 weeks
A device Pain vision Ⓡ PS-2100 calculates a "degree of pain" in cancer patients in addition to VAS
Chagnes from baseline to 5 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: After the initiation of acupuncture, 2 weeks, and 4 weeks
We will confirm the safety of acupuncture by determining the red blood cell (RBC) count, hemoglobin level, platelet count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), hematocrit (Hct), total white blood cell (WBC) count, Erythrocyte Sedimentation Rate (ESR), aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum urea nitrogen (BUN), creatinine level, serum sodium level, serum potassium level, and serum chloride level. All patients were evaluated 3 times, including a final follow-up visit 4 weeks after the initiation of acupuncture.
After the initiation of acupuncture, 2 weeks, and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daegu Catholic University Medical Center

Investigators

  • Principal Investigator: Seong-Hoon Park, KMD, Comprehensive and Integrative Medicine Insitute
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 25, 2013

First Posted (Estimate)

July 26, 2013

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 2, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIMI-13-01-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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