The Evaluation of Single Acupoint Therapy to Acute Low Back Pain

NCT04328428 | Unknown

• 1 other identifier: 202000002A3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture; Acute Low Back Pain

Keywords

acute low back pain; BL40; Extra Meridian 32 (EM32); acupuncture

Outcome Measures

Primary Outcomes (2)

• 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

• range of motion measurement

  measure the range of motion when lumbar extension and flexion

  30 minutes

Study Arms (3)

(A)modified BL40 acupuncture

EXPERIMENTAL

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

Other: acupuncture

(B)EM32 acupuncture

ACTIVE COMPARATOR

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

Other: acupuncture

(C)BL40 acupuncture

ACTIVE COMPARATOR

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

Other: acupuncture

Interventions

acupuncture OTHER

Use one acupuncture needle insert in a acupoint.

(A)modified BL40 acupuncture; (B)EM32 acupuncture; (C)BL40 acupuncture

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Dept of Chinese medicine, Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

Related Publications (6)

• 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.

  PMID: 26063472 BACKGROUND

• 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.

  PMID: 23038621 BACKGROUND

• 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.

  PMID: 16595438 BACKGROUND

• 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.

  PMID: 9085296 BACKGROUND

• 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.

  PMID: 17658288 BACKGROUND

• 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.

  PMID: 22770838 BACKGROUND

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ko-Hung Lee, MD

  ChangGung Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Yuan-Xin Lai, MD

CONTACT

+886-3-3196200; u9802401@cmu.edu.tw

Ko-Hung Lee, MD

CONTACT

+886-3-3196200; greglgc@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants only know that they accept acupuncture ,but do not know which acupoint needling they receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: March 31, 2020
• Study Start: March 28, 2020
• Primary Completion: February 12, 2021
• Study Completion: February 12, 2021
• Last Updated: April 8, 2020

Record last verified: 2020-02

Locations

TW (1)