Predicting Outcome of Transcutaneous Electrical Nerve Stimulator (TENS) in Failed Back Surgery Syndrome
1 other identifier
interventional
40
1 country
1
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 pain at the lower back and leg after spinal surgery with a predominance of pain in the leg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2010
CompletedFirst Posted
Study publicly available on registry
August 20, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedAugust 20, 2010
August 1, 2010
1 year
August 19, 2010
August 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the feasibility to use TENS devices in Failed Back Surgery Syndrome (FBSS) as a non-invasive method to treat neuropathic pain.
To evaluate the feasibility to use TENS devices in Failed Back Surgery Syndrome (FBSS) as a non-invasive method to treat neuropathic pain using pain scores, QOL scores and depression scores
1 year
Study Arms (2)
TENS
ACTIVE COMPARATORFBSS patients treated with TENS
Sham-TENS
PLACEBO COMPARATORpatients treated with Sham-Tens
Interventions
Eligibility Criteria
You may qualify if:
- 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%)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitair Ziekenhuis Brussellead
- Evenepoel Kristofcollaborator
- De Rudder Marccollaborator
- Dokter Moens Maarten (primary investigator)collaborator
- Prof. dr. Cattrysse Ericcollaborator
- Prof. Dr. D'Haens Jeancollaborator
Study Sites (1)
UZ Brussel
Brussels, Vlaams Brabant, 1090, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maarten Moens, M.D.
Universitair Ziekenhuis Brussel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 19, 2010
First Posted
August 20, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
August 20, 2010
Record last verified: 2010-08