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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

Tracking Information
First Submitted Date  ICMJE August 21, 2013
First Posted Date  ICMJE August 27, 2013
Last Update Posted Date August 27, 2013
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study
Official Title  ICMJE Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Specific pain spot
    Radial Extracorporeal Shock Wave Therapy 2000 impulses, Patients with specific pain spot for low back pain
    Intervention: Device: Radial Extracorporeal Shock Wave Therapy 2000 impulses
  • Experimental: No specific pain spot
    Radial Extracorporeal Shock Wave Therapy 4000 impulses, Patients without specific pain spot for low back pain
    Intervention: Device: Radial Extracorporeal Shock Wave Therapy 4000 impulses
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 22, 2013)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2013
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01928784
Other Study ID Numbers  ICMJE SW-LBP-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cheng Zeng, Beijing Jishuitan Hospital
Study Sponsor  ICMJE Beijing Jishuitan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yajun Liu, MD Beijing Jishuitan Hospital
Principal Investigator: Yan An, MD Beijing Jishuitan Hospital
PRS Account Beijing Jishuitan Hospital
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP