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

August 22, 2013 updated by: Cheng Zeng, Beijing Jishuitan Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100035
        • Recruiting
        • Beijing Jishuitan Hospital
        • Contact:
        • Principal Investigator:
          • Yan An, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • SWISS DOLORCLAST® CLASSIC, EMS, Swiss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 1 hour after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Jishuitan Hospital

Investigators

  • Study Director: Yajun Liu, MD, Beijing Jishuitan Hospital
  • Principal Investigator: Yan An, MD, Beijing Jishuitan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

August 22, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

August 27, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SW-LBP-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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