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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928784
Recruitment Status : Unknown
Verified August 2013 by Cheng Zeng, Beijing Jishuitan Hospital.
Recruitment status was:  Recruiting
First Posted : August 27, 2013
Last Update Posted : August 27, 2013
Sponsor:
Information provided by (Responsible Party):
Cheng Zeng, 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Radial Extracorporeal Shock Wave Therapy 2000 impulses Device: Radial Extracorporeal Shock Wave Therapy 4000 impulses Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study
Study Start Date : June 2013
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Shock

Arm Intervention/treatment
Experimental: Specific pain spot
Radial Extracorporeal Shock Wave Therapy 2000 impulses, Patients with specific pain spot for low back pain
Device: Radial Extracorporeal Shock Wave Therapy 2000 impulses
Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 2000 impulses
Other Name: SWISS DOLORCLAST® CLASSIC, EMS, Swiss

Experimental: No specific pain spot
Radial Extracorporeal Shock Wave Therapy 4000 impulses, Patients without specific pain spot for low back pain
Device: Radial Extracorporeal Shock Wave Therapy 4000 impulses
Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 4000 impulses
Other Name: SWISS DOLORCLAST® CLASSIC, EMS, Swiss




Primary Outcome Measures :
  1. Change in Visual analogue scale scores(VAS) of patients before and after therapy [ Time Frame: baseline, 1 hour after therapy ]
    Change of Visual analogue scale score(VAS) of patients before and after shock wave therapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928784


Contacts
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Contact: Wei Tian, MD +86-010-58516688 drliuyajun@163.com

Locations
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China, Beijing
Beijing Jishuitan Hospital Recruiting
Beijing, Beijing, China, 100035
Contact: Yan An, MD    +86-13693163634    weilanersheng@sina.com   
Principal Investigator: Yan An, MD         
Sponsors and Collaborators
Beijing Jishuitan Hospital
Investigators
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Study Director: Yajun Liu, MD Beijing Jishuitan Hospital
Principal Investigator: Yan An, MD Beijing Jishuitan Hospital
Publications:
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Responsible Party: Cheng Zeng, MD, Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier: NCT01928784    
Other Study ID Numbers: SW-LBP-01
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: August 2013
Keywords provided by Cheng Zeng, Beijing Jishuitan Hospital:
Low back pain
extracorporeal shock wave therapy
Trigger Points
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations