Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Universitair Ziekenhuis Brussel.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Evenepoel Kristof
De Rudder Marc
Dokter Moens Maarten (primary investigator)
Prof. dr. Cattrysse Eric
Prof. Dr. D'Haens Jean
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01185665
First received: August 19, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Failed Back Surgery Syndrome
Device: TENS
Device: Sham-TENS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • To evaluate the feasibility to use TENS devices in Failed Back Surgery Syndrome (FBSS) as a non-invasive method to treat neuropathic pain. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TENS
FBSS patients treated with TENS
Device: TENS
Transcutaneous Electrical Nerve Stimulator
Placebo Comparator: Sham-TENS
patients treated with Sham-Tens
Device: Sham-TENS
TENS without electrical output, from the outside not different from a normal TENS

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, electrical stimulations for pain relief have spread worldwide.

The most known technique is Transcutaneous Electrical Nerve Stimulator (TENS). Surface electrodes are placed over the lower back (paravertebral at level L1-L2) it and the stimulation is delivered at high frequency and low intensity (below pain threshold), to produce an intense activation of Ab afferents and to evoke paresthesiae that cover the painful area.

In the literature about TENS in neuropathic pain a few controlled trials (classes II-IV) were found 2-8. The most studies dealt with painful diabetic neuropathy were very-high-frequency stimulation of lower-limb muscles were found more efficacious than standard TENS and low-frequency TENS or acupuncture-like more efficacious than sham stimulations.

Studies dealing with peripheral mononeuropathies found standard TENS better than placebo.

One crossover, small-sample study (class III) in painful cervical radiculopathy found that standard TENS applied to the cervical back was better than placebo but a TENS with random frequency variation was superior7. For chronic back pain no benefit was found for TENS compared to TENS-sham using a VAS and other outcome measures, but benefit was found comparing exercise to no exercise (Class I)9. In another Class I study, TENS vs TENS-sham was studied in patients with multiple sclerosis (MS) and chronic low back pain. After correction for multiple comparisons, there were no significant differences in the VAS or the secondary measures10. Both studies were adequately powered to find at least a 20% difference in pain reduction by VAS between TENS and TENS-sham. But in other articles no benefit were found for chronic back pain treated with TENS11,12. Therefore a recent report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology did not recommend TENS for the treatment of chronic low back pain due to lack of proven efficacy but TENS should be considered for the treatment of painful diabetic neuropathy 13

In our study design, we will investigate the feasibility and efficacy of 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185665

Contacts
Contact: Maarten Moens, M.D. 0032478884047 mtmoens@gmail.com

Locations
Belgium
UZ Brussel Not yet recruiting
Brussels, Vlaams Brabant, Belgium, 1090
Contact: Maarten Moens, M.D.         
Principal Investigator: Maarten Moens, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Evenepoel Kristof
De Rudder Marc
Dokter Moens Maarten (primary investigator)
Prof. dr. Cattrysse Eric
Prof. Dr. D'Haens Jean
Investigators
Principal Investigator: Maarten Moens, M.D. UZ Brussel
  More Information

No publications provided

Responsible Party: Dr. Moens Maarten, UZ Brussel
ClinicalTrials.gov Identifier: NCT01185665     History of Changes
Other Study ID Numbers: vubmtmoensTENS
Study First Received: August 19, 2010
Last Updated: August 19, 2010
Health Authority: Belgium:Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten

Keywords provided by Universitair Ziekenhuis Brussel:
FBSS

Additional relevant MeSH terms:
Failed Back Surgery Syndrome
Syndrome
Back Pain
Disease
Nervous System Diseases
Neurologic Manifestations
Pain
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on November 25, 2014