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Efficacy Study of Acupuncture to Treat Spinal Pain

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acupuncture
Epidural 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 Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Daegu Catholic University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture & Epidural nerve block

Epidural nerve block

Arm Description

acupuncture plus epidural block

epidural block alone

Outcomes

Primary Outcome Measures

Visual analogue scale(VAS)
This outcome will measure changes in the participant's level of low back pain.

Secondary Outcome Measures

Short form McGill pain questionnaire
Oswestry Disability Index
Present pain intensity(PPI)
Pain vision
A device Pain vision Ⓡ PS-2100 calculates a "degree of pain" in cancer patients in addition to VAS

Full Information

First Posted
July 18, 2013
Last Updated
February 2, 2014
Sponsor
Daegu Catholic University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01909284
Brief Title
Efficacy Study of Acupuncture to Treat Spinal Pain
Official Title
Pilot Study of Efficacy and Safety of Acupuncture on Patient With Spinal Pain Due to Spondylolithesis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Acupuncture & Epidural nerve block
Arm Type
Experimental
Arm Description
acupuncture plus epidural block
Arm Title
Epidural nerve block
Arm Type
Active Comparator
Arm Description
epidural block alone
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
BL40, BL60, ST36, GB34 : bilaterally, manual acupuncture. Two points on 1st bladder meridian nearest location of back pain : bilaterally, electrical acupuncture.
Intervention Type
Procedure
Intervention Name(s)
Epidural nerve block
Intervention Description
Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).
Primary Outcome Measure Information:
Title
Visual analogue scale(VAS)
Description
This outcome will measure changes in the participant's level of low back pain.
Time Frame
Change from baseline to 5 weeks
Secondary Outcome Measure Information:
Title
Short form McGill pain questionnaire
Time Frame
Chagnes from baseline to 5 weeks
Title
Oswestry Disability Index
Time Frame
Changes from baseline to 5 weeks
Title
Present pain intensity(PPI)
Time Frame
Changes from baseline to 5 weeks
Title
Pain vision
Description
A device Pain vision Ⓡ PS-2100 calculates a "degree of pain" in cancer patients in addition to VAS
Time Frame
Chagnes from baseline to 5 weeks
Other Pre-specified Outcome Measures:
Title
Safety
Description
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.
Time Frame
After the initiation of acupuncture, 2 weeks, and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Un-Suk Noh, M.D,Ph.D
Phone
+82 53 650 4054
Email
usno@cu.ac.kr
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
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
24693959
Citation
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.
Results Reference
derived

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Efficacy Study of Acupuncture to Treat Spinal Pain

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