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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radial Extracorporeal Shock Wave Therapy 2000 impulses
Radial Extracorporeal Shock Wave Therapy 4000 impulses
Sponsored by
Beijing Jishuitan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, extracorporeal shock wave therapy, Trigger Points

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Jishuitan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Specific pain spot

No specific pain spot

Arm Description

Radial Extracorporeal Shock Wave Therapy 2000 impulses, Patients with specific pain spot for low back pain

Radial Extracorporeal Shock Wave Therapy 4000 impulses, Patients without specific pain spot for low back pain

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 21, 2013
Last Updated
August 22, 2013
Sponsor
Beijing Jishuitan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01928784
Brief Title
Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study
Official Title
Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Jishuitan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, extracorporeal shock wave therapy, Trigger Points

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Specific pain spot
Arm Type
Experimental
Arm Description
Radial Extracorporeal Shock Wave Therapy 2000 impulses, Patients with specific pain spot for low back pain
Arm Title
No specific pain spot
Arm Type
Experimental
Arm Description
Radial Extracorporeal Shock Wave Therapy 4000 impulses, Patients without specific pain spot for low back pain
Intervention Type
Device
Intervention Name(s)
Radial Extracorporeal Shock Wave Therapy 2000 impulses
Other Intervention Name(s)
SWISS DOLORCLAST® CLASSIC, EMS, Swiss
Intervention Description
Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 2000 impulses
Intervention Type
Device
Intervention Name(s)
Radial Extracorporeal Shock Wave Therapy 4000 impulses
Other Intervention Name(s)
SWISS DOLORCLAST® CLASSIC, EMS, Swiss
Intervention Description
Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 4000 impulses
Primary Outcome Measure Information:
Title
Change in Visual analogue scale scores(VAS) of patients before and after therapy
Description
Change of Visual analogue scale score(VAS) of patients before and after shock wave therapy
Time Frame
baseline, 1 hour after therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Tian, MD
Phone
+86-010-58516688
Email
drliuyajun@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yajun Liu, MD
Organizational Affiliation
Beijing Jishuitan Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yan An, MD
Organizational Affiliation
Beijing Jishuitan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Jishuitan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan An, MD
Phone
+86-13693163634
Email
weilanersheng@sina.com
First Name & Middle Initial & Last Name & Degree
Yan An, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21982256
Citation
Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
Results Reference
background
PubMed Identifier
20494814
Citation
Dagenais S, Tricco AC, Haldeman S. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. Spine J. 2010 Jun;10(6):514-29. doi: 10.1016/j.spinee.2010.03.032.
Results Reference
background

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

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