Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study

Study Overview
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Brief Summary
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The aim of this prospective study is to explore the pain-alleviating effect of low-energy extracorporeal shock wave therapy(ESWT) in patients with chronic low back pain.

Detailed Description
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26 patients who suffered from persistent symptoms for more than 3 months are going to be treated with DOLORCLAST radial extracorporeal shock wave(EMS, Swiss). Patients are assigned to two groups according to the exist of specific pain spot. Group I(have specific pain spot) received a total of 2000 impulses of 2.5 Bar; group II(controls, no specific pain spot) 4000 impulses of 2.5 Bar. Patients is going to be treated once. The efficacy of therapy is going to be evaluated by VAS scale before and after the treatment.

Official Title
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Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Radial Extracorporeal Shock Wave Therapy 2000 impulses
* Device: Radial Extracorporeal Shock Wave Therapy 4000 impulses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptom of low back pain during last 4 weeks Low back pain history for more than 3 months Exclusion Criteria: Have lower limbs radiating pain beyond knee joints Spinal tumorous or infectious disease, fracture, ankylosing spondylitis, cauda equina syndrome or other severe spinal diseases Spinal surgical history Severe heart, lung, liver, kidney disease or high blood pressure With cardiac pacemaker Coagulopathy or thrombosis Have ESW therapy or pharmaceutical treatment for low back pain during last 1 months Mental illnesses or none cooperation Pregnancy

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Specific pain spot<br>Radial Extracorporeal Shock Wave Therapy 2000 impulses, Patients with specific pain spot for low back pain | Device: Radial Extracorporeal Shock Wave Therapy 2000 impulses<br>* Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 2000 impulses<br>* Other names: SWISS DOLORCLAST® CLASSIC, EMS, Swiss;|
| Experimental: No specific pain spot<br>Radial Extracorporeal Shock Wave Therapy 4000 impulses, Patients without specific pain spot for low back pain | Device: Radial Extracorporeal Shock Wave Therapy 4000 impulses<br>* Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 4000 impulses<br>* Other names: SWISS DOLORCLAST® CLASSIC, EMS, Swiss;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual analogue scale scores(VAS) of patients before and after therapy | Change of Visual analogue scale score(VAS) of patients before and after shock wave therapy | baseline, 1 hour after therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, extracorporeal shock wave therapy, Trigger Points