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

Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability: a Randomised, Controlled, Trial Protocol

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.

Study Overview

• Status: Completed
• Conditions: Complete Immobility Due to Severe Physical Disability
• Intervention / Treatment: Other: acupuncture, injection

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Jaseng Oriental Hospital
  • Gangnamgu Sinsadong
    • Seoul, Gangnamgu Sinsadong, Korea, Republic of
      • Jaseng Oriental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in numerical rating scale of back pain	Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.

Collaborators and Investigators

• Sponsor: Jaseng Hospital of Korean Medicine
• Investigators: Principal Investigator: Joonshik Shin, JASENG HOSPITAL

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2011
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: March 14, 2011
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (ESTIMATE): March 15, 2011

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: disability; acute low back pain; MSAT; motion stlye acupuncture treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: JSR-2011-01