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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01928784
• Other study ID #: SW-LBP-01
• Status: Recruiting
• Phase: N/A
• First received: August 21, 2013
• Last updated: August 22, 2013
• Start date: June 2013
• Est. completion date: September 2013

Study information

• Verified date: August 2013
• Source: Beijing Jishuitan Hospital
• Contact: Wei Tian, MD
• Phone: +86-010-58516688
• Email: drliuyajun[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Radial Extracorporeal Shock Wave Therapy 2000 impulses
Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 2000 impulses
• Radial Extracorporeal Shock Wave Therapy 4000 impulses
Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 4000 impulses

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Balagué F, Mannion AF, Pellisé 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline, 1 hour after therapy	Yes