Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Complete Immobility Due to Severe Physical Disability

Intervention / Treatment
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* Other: acupuncture, injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture<br>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<br>* MSAT and intramuscular injections of diclofenac(NSAID)<br>|
| Active Comparator: injections of diclofenac<br>the control group was treated with intramuscular injections of diclofenac(NSAID). All administrations were limited to 1 session | Other: acupuncture, injection<br>* MSAT and intramuscular injections of diclofenac(NSAID)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute low back pain, motion stlye acupuncture treatment, disability, MSAT