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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaseng Hospital of Oriental Medicine
ClinicalTrials.gov Identifier:
NCT01315561
First received: March 14, 2011
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Complete Immobility Due to Severe Physical Disability
 Other: acupuncture, injection
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability: a Randomised, Controlled, Trial Protocol

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jaseng Hospital of Oriental Medicine:

Primary Outcome Measures:
  • Change from Baseline in numerical rating scale of back pain [ Time Frame: Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment. ] [ Designated as safety issue: No ]

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) [ Time Frame: Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 58
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acupuncture
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.
 Other: acupuncture, injection
MSAT and intramuscular injections of diclofenac(NSAID)
Active Comparator: injections of diclofenac
the control group was treated with intramuscular injections of diclofenac(NSAID). All administrations were limited to 1 session
 Other: acupuncture, injection
MSAT and intramuscular injections of diclofenac(NSAID)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315561

Locations
Korea, Republic of
Jaseng Oriental Hospital
Seoul, Gangnamgu Sinsadong, Korea, Republic of
Jaseng Oriental Hospital
Bucheon, Korea, Republic of
Sponsors and Collaborators
Jaseng Hospital of Oriental Medicine
Investigators
Principal Investigator: Joonshik Shin JASENG HOSPITAL
  More Information

No publications provided by Jaseng Hospital of Oriental Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jaseng Hospital of Oriental Medicine
ClinicalTrials.gov Identifier: NCT01315561     History of Changes
Other Study ID Numbers: JSR-2011-01
Study First Received: March 14, 2011
Last Updated: October 3, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Jaseng Hospital of Oriental Medicine:
acute low back pain
motion stlye acupuncture treatment
disability
MSAT

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013