Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability

NCT ID: NCT01315561

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-04-30

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.

Conditions

Complete Immobility Due to Severe Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

acupuncture, injection

Intervention Type: OTHER

MSAT and intramuscular injections of diclofenac(NSAID)

injections of diclofenac

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

Group Type: ACTIVE_COMPARATOR

acupuncture, injection

Intervention Type: OTHER

MSAT and intramuscular injections of diclofenac(NSAID)

Interventions

acupuncture, injection

MSAT and intramuscular injections of diclofenac(NSAID)

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaseng Hospital of Korean Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joonshik Shin

Role: PRINCIPAL_INVESTIGATOR

JASENG HOSPITAL

Locations

Jaseng Oriental Hospital

Seoul, Gangnamgu Sinsadong, South Korea

Jaseng Oriental Hospital

Bucheon-si, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 22151475 (View on PubMed)

Other Identifiers

JSR-2011-01

Identifier Type: -

Identifier Source: org_study_id