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

Overview

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 Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: August 2013

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.

Interventions

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

Arms, Groups and Cohorts

• Experimental: Specific pain spot
  • Radial Extracorporeal Shock Wave Therapy 2000 impulses, Patients with specific pain spot for low back pain
• Experimental: No specific pain spot
  • Radial Extracorporeal Shock Wave Therapy 4000 impulses, Patients without specific pain spot for low back pain

Clinical Trial Outcome Measures

Primary Measures

• 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Beijing Jishuitan Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Cheng Zeng, MD – Beijing Jishuitan Hospital
• Overall Official(s)
  • Yajun Liu, MD, Study Director, Beijing Jishuitan Hospital
  • Yan An, MD, Principal Investigator, Beijing Jishuitan Hospital
• Overall Contact(s)
  • Wei Tian, MD, +86-010-58516688, drliuyajun@163.com

References

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.

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.