The Evaluation of Single Acupoint Therapy to Acute Low Back Pain

April 6, 2020 updated by: Chang Gung Memorial Hospital

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

Unknown

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

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan
        • Recruiting
        • Dept of Chinese medicine, Chang Gung Memorial Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: acupuncture
Use one acupuncture needle insert in a acupoint.
ACTIVE_COMPARATOR: (B)EM32 acupuncture
EM32 acupuncture Participants receive EM32 acupuncture once on the opposite site.
Other: acupuncture
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
Other: acupuncture
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

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: Ko-Hung Lee, MD, ChangGung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 28, 2020

Primary Completion (ANTICIPATED)

February 12, 2021

Study Completion (ANTICIPATED)

February 12, 2021

Study Registration Dates

First Submitted

March 29, 2020

First Submitted That Met QC Criteria

March 29, 2020

First Posted (ACTUAL)

March 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202000002A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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