Status:

UNKNOWN

Predicting Outcome of Transcutaneous Electrical Nerve Stimulator (TENS) in Failed Back Surgery Syndrome

Lead Sponsor:

Universitair Ziekenhuis Brussel

Collaborating Sponsors:

Evenepoel Kristof

De Rudder Marc

Conditions:

Failed Back Surgery Syndrome

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The study investigates the feasibility and efficacy of Transcutaneous Electrical Nerve Stimulator (TENS) in a subgroup of patients with neuropathic pain. Those patients are suffering of neuropathic pa...

Detailed Description

Derived from folk tradition, the notion that rubbing the skin over a painful area relieves pain, found scientific support in the gate-control theory proposed by Melzack and Wall 1. Since then, electri...

Eligibility Criteria

Inclusion

  • Inclusions:
  • Age male/female patient ≥ 18 years
  • Patient diagnosed with Failed Back Surgery Syndrome with at least one prior spinal surgery
  • Patient with low back pain and/or pain in at least one leg
  • Pain intensity at baseline assessed by VAS \> 5 (50%)

Exclusion

  • Exclusions:
  • Formerly treated with TENS
  • Several unrelated sites of pain
  • Cognitive impairment
  • No help to replace electrodes
  • Ongoing litigation
  • Psychological intervention
  • Language difficulties
  • No informed consent
  • Existing or planned pregnancy
  • Age male/female patient \<18 years

Key Trial Info

Start Date :

September 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2011

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT01185665

Start Date

September 1 2010

End Date

September 1 2011

Last Update

August 20 2010

Active Locations (1)

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Page 1 of 1 (1 locations)

1

UZ Brussel

Brussels, Vlaams Brabant, Belgium, 1090