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

B

Beijing Jishuitan Hospital

Status

Unknown

Conditions

Low Back Pain

Treatments

Device: Radial Extracorporeal Shock Wave Therapy 2000 impulses
Device: Radial Extracorporeal Shock Wave Therapy 4000 impulses

Study type

Interventional

Funder types

Other

Identifiers

NCT01928784
SW-LBP-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Wei Tian, MD

Data sourced from clinicaltrials.gov

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