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

Not Applicable

• Conditions: Low Back Pain
• Interventions: Device: Radial Extracorporeal Shock Wave Therapy 2000 impulses; Device: Radial Extracorporeal Shock Wave Therapy 4000 impulses

• Registration Number: NCT01928784
• Lead Sponsor: Beijing Jishuitan Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-06
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-22
• Last Update Submitted: 2013-08-22
• Study First Posted: 2013-08-27
• Last Update Posted: 2013-08-27
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Specific pain spot	Radial Extracorporeal Shock Wave Therapy 2000 impulses	Radial Extracorporeal Shock Wave Therapy 2000 impulses, Patients with specific pain spot for low back pain
No specific pain spot	Radial Extracorporeal Shock Wave Therapy 4000 impulses	Radial Extracorporeal Shock Wave Therapy 4000 impulses, Patients without specific pain spot for low back pain

Primary Outcome Measures

Name	Time	Method
Change in Visual analogue scale scores(VAS) of patients before and after therapy	baseline, 1 hour after therapy	Change of Visual analogue scale score(VAS) of patients before and after shock wave therapy

Trial Locations

Locations (1)

Beijing Jishuitan Hospital; 🇨🇳 Beijing, Beijing, China