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The Evaluation of Single Acupoint Therapy to Acute Low Back Pain

Primary Purpose

Acupuncture, Acute Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture focused on measuring acute low back pain, BL40, Extra Meridian 32 (EM32), acupuncture

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • low back pain,duration < 1 month
  • accept subject consent

Exclusion Criteria:

  • without X ray or MRI image
  • severe trauma , fracture or spondylosis found from image ,progression neurological symptoms suspected from central nerve system, rheumatic disease, fever or infection is suspected ,weight or cancer history , pregnancy and psychiatric disorder or not able to communication .

Sites / Locations

  • Dept of Chinese medicine, Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

(A)modified BL40 acupuncture

(B)EM32 acupuncture

(C)BL40 acupuncture

Arm Description

modified BL40 acupuncture Participants receive BL40 acupuncture once on the same site of low back pain.

EM32 acupuncture Participants receive EM32 acupuncture once on the opposite site.

BL40 acupuncture Participants receive BL40 acupuncture once on the same site of low back pain

Outcomes

Primary Outcome Measures

pain measurement
use Visual Analogue Scale to measure pain intensity and algometer to measure pain threshold The minimum of Visual Analogue Scale is 0 and maximum values is 10. The higher Visual Analogue Scale mean a worse outcome . Newton is used to measure pain threshold. The higher pain threshold scores mean a better outcome .
range of motion measurement
measure the range of motion when lumbar extension and flexion

Secondary Outcome Measures

Full Information

First Posted
March 29, 2020
Last Updated
April 6, 2020
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04328428
Brief Title
The Evaluation of Single Acupoint Therapy to Acute Low Back Pain
Official Title
The Evaluation of Single Acupoint Therapy to Acute Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2020 (Anticipated)
Primary Completion Date
February 12, 2021 (Anticipated)
Study Completion Date
February 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Low back pain is the leading course of disability , affecting patients' health and work. Recently, studies have reveal the fact that patients get insufficient physical activity and easily let acute stage turn to chronic type. Although acupuncture for low back pain is worldwide popular, the mechanism of single acupoint for low back pain is still unclear. Therefore, the aim of this study is the investigators choose the most frequent used acupoint and modified single acupoint method to assess the efficacy of single acupoint to acute low back pain.
Detailed Description
Low back pain is the leading course of disability , affecting patients' health and work. According to the study in 2013, 8.9 percent people of the world experienced over three months low back pain. Recently, studies have reveal the fact that patients get insufficient physical activity and easily let acute stage turn to chronic type. Although acupuncture for low back pain is worldwide popular, the mechanism of single acupoint for low back pian is still unclear. Therefore, the investigators choose the most frequent used acupoint and modified single acupoint method to assess the efficacy of single acupoint to acute low back pain. The investigators would like to compare the efficacy of the modified Bladder 40 (BL40) acupuncture to single acupoint through statistical analysis. The investigators expect that all group will alleviate low back pain. However, treatment group will have statistical difference compared with control groups. The aim of this study is the investigators choose the most frequent used acupoint and modified single acupoint method to assess the efficacy of single acupoint to acute low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Acute Low Back Pain
Keywords
acute low back pain, BL40, Extra Meridian 32 (EM32), acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
three groups randomly:experiment group and two control groups. Patients in experiment group receive modified BL40 acupuncture. Control group one receives EM32 acupuncture and control group two receives BL40 acupuncture
Masking
Participant
Masking Description
The participants only know that they accept acupuncture ,but do not know which acupoint needling they receive.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
(A)modified BL40 acupuncture
Arm Type
Experimental
Arm Description
modified BL40 acupuncture Participants receive BL40 acupuncture once on the same site of low back pain.
Arm Title
(B)EM32 acupuncture
Arm Type
Active Comparator
Arm Description
EM32 acupuncture Participants receive EM32 acupuncture once on the opposite site.
Arm Title
(C)BL40 acupuncture
Arm Type
Active Comparator
Arm Description
BL40 acupuncture Participants receive BL40 acupuncture once on the same site of low back pain
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
Use one acupuncture needle insert in a acupoint.
Primary Outcome Measure Information:
Title
pain measurement
Description
use Visual Analogue Scale to measure pain intensity and algometer to measure pain threshold The minimum of Visual Analogue Scale is 0 and maximum values is 10. The higher Visual Analogue Scale mean a worse outcome . Newton is used to measure pain threshold. The higher pain threshold scores mean a better outcome .
Time Frame
30 minutes
Title
range of motion measurement
Description
measure the range of motion when lumbar extension and flexion
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: low back pain,duration < 1 month accept subject consent Exclusion Criteria: without X ray or MRI image severe trauma , fracture or spondylosis found from image ,progression neurological symptoms suspected from central nerve system, rheumatic disease, fever or infection is suspected ,weight or cancer history , pregnancy and psychiatric disorder or not able to communication .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan-Xin Lai, MD
Phone
+886-3-3196200
Ext
2613
Email
u9802401@cmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ko-Hung Lee, MD
Phone
+886-3-3196200
Ext
2613
Email
greglgc@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ko-Hung Lee, MD
Organizational Affiliation
ChangGung Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dept of Chinese medicine, Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ko-Hung Lee, MD
Phone
+886-3-3196200
Ext
2613
Email
greglgc@cgmh.org
First Name & Middle Initial & Last Name & Degree
Yuan-Xin Lai, MD
Phone
+886-3-3196200
Ext
2613
Email
u9802401@cmu.edu.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
26063472
Citation
Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Aug 22;386(9995):743-800. doi: 10.1016/S0140-6736(15)60692-4. Epub 2015 Jun 7.
Results Reference
background
PubMed Identifier
23038621
Citation
Hong J, Reed C, Novick D, Happich M. Costs associated with treatment of chronic low back pain: an analysis of the UK General Practice Research Database. Spine (Phila Pa 1976). 2013 Jan 1;38(1):75-82. doi: 10.1097/BRS.0b013e318276450f.
Results Reference
background
PubMed Identifier
16595438
Citation
Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.
Results Reference
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PubMed Identifier
9085296
Citation
Asmundson GJG, Norton RG, Allerdings MD. Fear and avoidance in dysfunctional chronic back pain patients. Pain. 1997 Feb;69(3):231-236. doi: 10.1016/S0304-3959(96)03288-5.
Results Reference
background
PubMed Identifier
17658288
Citation
Kent PM, Keating JL. Can we predict poor recovery from recent-onset nonspecific low back pain? A systematic review. Man Ther. 2008 Feb;13(1):12-28. doi: 10.1016/j.math.2007.05.009. Epub 2007 Jul 19.
Results Reference
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PubMed Identifier
22770838
Citation
Vas J, Aranda JM, Modesto M, Benitez-Parejo N, Herrera A, Martinez-Barquin DM, Aguilar I, Sanchez-Araujo M, Rivas-Ruiz F. Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial. Pain. 2012 Sep;153(9):1883-1889. doi: 10.1016/j.pain.2012.05.033. Epub 2012 Jul 4.
Results Reference
background

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The Evaluation of Single Acupoint Therapy to Acute Low Back Pain

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