NCT01928784

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 27, 2013

Status Verified

August 1, 2013

Enrollment Period

2 months

First QC Date

August 21, 2013

Last Update Submit

August 22, 2013

Conditions

Low Back Pain

Keywords

Low back painextracorporeal shock wave therapyTrigger Points

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Specific pain spot

EXPERIMENTAL

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

Device: Radial Extracorporeal Shock Wave Therapy 2000 impulses

No specific pain spot

EXPERIMENTAL

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

Device: Radial Extracorporeal Shock Wave Therapy 4000 impulses

Interventions

Radial Extracorporeal Shock Wave Therapy 2000 impulsesDEVICE

Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 2000 impulses

Also known as: SWISS DOLORCLAST® CLASSIC, EMS, Swiss
Specific pain spot
Radial Extracorporeal Shock Wave Therapy 4000 impulsesDEVICE

Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 4000 impulses

Also known as: SWISS DOLORCLAST® CLASSIC, EMS, Swiss
No specific pain spot

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Symptom of low back pain during last 4 weeks
  • Low back pain history for more than 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 21982256BACKGROUND

  • 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.

    PMID: 20494814BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Emergency Treatment

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Yajun Liu, MD

    Beijing Jishuitan Hospital

    STUDY DIRECTOR

  • Yan An, MD

    Beijing Jishuitan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Tian, MD

CONTACT

+86-010-58516688drliuyajun@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 21, 2013

First Posted

August 27, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

August 27, 2013

Record last verified: 2013-08

Locations

CN(1)