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Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability (MSAT)

Primary Purpose

Complete Immobility Due to Severe Physical Disability

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
acupuncture, injection
Sponsored by
Jaseng Hospital of Korean Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complete Immobility Due to Severe Physical Disability focused on measuring acute low back pain, motion stlye acupuncture treatment, disability, MSAT

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute LBP(with or without leg pain), with onset within past 4 weeks
  • Severe disability as assessed by an Oswestry Disability Index of 60% or higher
  • Age between 20 and 60
  • Given consent to lumbar MRI
  • Voluntary participation with written consent given to study consent form

Exclusion Criteria:

  • Diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc.
  • Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.
  • Progressive neurologic deficit(s) or concurrent severe neurological symptoms
  • Unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc.
  • Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher
  • Experience of gastroenteric complications after taking NSAIDs or currently undergoing treatment for digestive disorders
  • During pregnancy or suspected pregnancy
  • Subjects considered unsuitable for clinical trial by the researcher

Sites / Locations

  • Jaseng Oriental Hospital
  • Jaseng Oriental Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

acupuncture

injections of diclofenac

Arm Description

MSAT is a treatment method in which the patient is exposed to active or passive movement and exercise during acupuncture, as opposed to conventional acupuncture.

the control group was treated with intramuscular injections of diclofenac(NSAID). All administrations were limited to 1 session

Outcomes

Primary Outcome Measures

Change from Baseline in numerical rating scale of back pain

Secondary Outcome Measures

Change from Baseline in NRS of radiating pain, ODI scores, and the patient's global impression of change(PGIC),range of motion (ROM) of the lumbar spine, and degrees of straight leg raising (SLR)
Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment.

Full Information

First Posted
March 14, 2011
Last Updated
November 5, 2018
Sponsor
Jaseng Hospital of Korean Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01315561
Brief Title
Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability
Acronym
MSAT
Official Title
Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability: a Randomised, Controlled, Trial Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaseng Hospital of Korean Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Motion style acupuncture treatment(MSAT) is a treatment method in which the patient is exposed to active or passive movement and exercise during acupuncture, as opposed to conventional acupuncture. The purpose of this study is to investigate the effect of MSAT in the treating pain and severe functional disability in acute LBP patients.
Detailed Description
58 patients with acute LBP and severe disability with an Oswestry Disability Index(ODI) of 60% or higher were randomly allocated and divided into 2 groups. The experimental group was treated with MSAT and the control group was treated with intramuscular injections of diclofenac(NSAID). All administrations were limited to 1 session, and comparisons were made of measurements before and after treatment. Primary outcomes were measured by the NRS(numerical rating scale) of back pain in active movement. Secondary outcomes were measured by the NRS of radiating pain, ODI scores, and the patient's global impression of change(PGIC) etc. Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Immobility Due to Severe Physical Disability
Keywords
acute low back pain, motion stlye acupuncture treatment, disability, MSAT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Experimental
Arm Description
MSAT is a treatment method in which the patient is exposed to active or passive movement and exercise during acupuncture, as opposed to conventional acupuncture.
Arm Title
injections of diclofenac
Arm Type
Active Comparator
Arm Description
the control group was treated with intramuscular injections of diclofenac(NSAID). All administrations were limited to 1 session
Intervention Type
Other
Intervention Name(s)
acupuncture, injection
Intervention Description
MSAT and intramuscular injections of diclofenac(NSAID)
Primary Outcome Measure Information:
Title
Change from Baseline in numerical rating scale of back pain
Time Frame
Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.
Secondary Outcome Measure Information:
Title
Change from Baseline in NRS of radiating pain, ODI scores, and the patient's global impression of change(PGIC),range of motion (ROM) of the lumbar spine, and degrees of straight leg raising (SLR)
Description
Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment.
Time Frame
Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute LBP(with or without leg pain), with onset within past 4 weeks Severe disability as assessed by an Oswestry Disability Index of 60% or higher Age between 20 and 60 Given consent to lumbar MRI Voluntary participation with written consent given to study consent form Exclusion Criteria: Diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc. Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc. Progressive neurologic deficit(s) or concurrent severe neurological symptoms Unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc. Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher Experience of gastroenteric complications after taking NSAIDs or currently undergoing treatment for digestive disorders During pregnancy or suspected pregnancy Subjects considered unsuitable for clinical trial by the researcher
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joonshik Shin
Organizational Affiliation
JASENG HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaseng Oriental Hospital
City
Seoul
State/Province
Gangnamgu Sinsadong
Country
Korea, Republic of
Facility Name
Jaseng Oriental Hospital
City
Bucheon
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22151475
Citation
Shin JS, Ha IH, Lee TG, Choi Y, Park BY, Kim MR, Lee MS. Motion style acupuncture treatment (MSAT) for acute low back pain with severe disability: a multicenter, randomized, controlled trial protocol. BMC Complement Altern Med. 2011 Dec 13;11:127. doi: 10.1186/1472-6882-11-127.
Results Reference
derived

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Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability

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