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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04328428
Other study ID # 202000002A3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 28, 2020
Est. completion date February 12, 2021

Study information

Verified date February 2020
Source Chang Gung Memorial Hospital
Contact Yuan-Xin Lai, MD
Phone +886-3-3196200
Email u9802401@cmu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date February 12, 2021
Est. primary completion date February 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
acupuncture
Use one acupuncture needle insert in a acupoint.

Locations

Country Name City State
Taiwan Dept of Chinese medicine, Chang Gung Memorial Hospital Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

Asmundson GJ, Norton GR, Allerdings MD. Fear and avoidance in dysfunctional chronic back pain patients. Pain. 1997 Feb;69(3):231-6. — View 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. Review. — View 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. — View 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. Review. — View 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. Epub 2007 Jul 19. Review. — View Citation

Vas J, Aranda JM, Modesto M, Benítez-Parejo N, Herrera A, Martínez-Barquín DM, Aguilar I, Sánchez-Araujo M, Rivas-Ruiz F. Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial. Pain. 2012 Sep;153(9):1883-9. doi: 10.1016/j.pain.2012.05.033. Epub 2012 Jul 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 . 30 minutes
Primary range of motion measurement measure the range of motion when lumbar extension and flexion 30 minutes
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