Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability

NCT01315561 | Completed Phase 3 DMC

• 1 other identifier: JSR-2011-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Complete Immobility Due to Severe Physical Disability

Keywords

acute low back pain; motion stlye acupuncture treatment; disability; MSAT

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in numerical rating scale of back pain

  Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.

Secondary Outcomes (1)

• 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)

  Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.

Study Arms (2)

acupuncture

EXPERIMENTAL

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

injections of diclofenac

ACTIVE COMPARATOR

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

Other: acupuncture, injection

Interventions

acupuncture, injection OTHER

MSAT and intramuscular injections of diclofenac(NSAID)

acupuncture; injections of diclofenac

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Hospital of Korean Medicine: lead

Study Sites (2)

Jaseng Oriental Hospital

Seoul, Gangnamgu Sinsadong, South Korea

Location

Jaseng Oriental Hospital

Bucheon-si, South Korea

Location

Related Publications (1)

• 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.

  PMID: 22151475 DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Joonshik Shin

  JASENG HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 15, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: April 1, 2012
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

KR (2)