The Evaluation of Single Acupoint Therapy to Acute Low Back Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taoyuan, Taiwan
- Recruiting
- Dept of Chinese medicine, Chang Gung Memorial Hospital
-
Contact:
- Yuan-Xin Lai, MD
- Phone Number: 2613 +886-3-3196200
- Email: u9802401@cmu.edu.tw
-
Contact:
- Ko-Hung Lee, MD
- Phone Number: 2613 +886-3-3196200
- Email: greglgc@cgmh.org
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: (A)modified BL40 acupuncture
modified BL40 acupuncture Participants receive BL40 acupuncture once on the same site of low back pain.
|
Use one acupuncture needle insert in a acupoint.
|
|
ACTIVE_COMPARATOR: (B)EM32 acupuncture
EM32 acupuncture Participants receive EM32 acupuncture once on the opposite site.
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Use one acupuncture needle insert in a acupoint.
|
|
ACTIVE_COMPARATOR: (C)BL40 acupuncture
BL40 acupuncture Participants receive BL40 acupuncture once on the same site of low back pain
|
Use one acupuncture needle insert in a acupoint.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain measurement
Time Frame: 30 minutes
|
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 .
|
30 minutes
|
|
range of motion measurement
Time Frame: 30 minutes
|
measure the range of motion when lumbar extension and flexion
|
30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ko-Hung Lee, MD, ChangGung Memorial Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202000002A3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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