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Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Pain, Responders and Non-Responders?

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Maastricht University Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00885859
First Posted: April 22, 2009
Last Update Posted: April 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maastricht University Medical Center
April 21, 2009
April 22, 2009
April 22, 2009
June 2009
December 2009   (Final data collection date for primary outcome measure)
Contact heat evoked potentials (CHEPS) [ Time Frame: before and after two weeks treatment ]
Same as current
No Changes Posted
Severity of pijn on average past week(100mm VAS) [ Time Frame: before and after two weeks treatment ]
Same as current
Not Provided
Not Provided
 
Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Pain, Responders and Non-Responders?
Is Transcutaneous Electrical Nerve Stimulation (TENS) an Effective Method to Modulate Pain Transmission and Pain Perception in Patients Suffering From Chronic Non-Specific Pain Syndromes?
  • Transcutaneous electrical nerve stimulation (TENS) is a frequently applied therapy in chronic pain. Although evidence regarding the effectiveness of TENS in chronic pain is inconclusive many patients continue using TENS on long term in daily practice. An important question is therefore why some patients respond well and others don't at all. In chronic pain evidence for abnormal pain processing (sensitization) has been found in several patients groups. The process of sensitization might influence effectiveness of TENS as the theoretical working mechanism of TENS is based on the modulation of the transmission of nociceptive impulses form peripheral receptors throughout spinal nerve system into the brain. In this study we want to study the effect of TENS on pain transmission, as measured by contact heat evoked potentials (CHEPS), between 'responders' and non-responders' after a two weeks TENS treatment. 'Responders' will be defined as patients with a pain reduction of ≥ 30% on a VAS after a two week treatment period with TENS. Non-responders are patients with a pain reduction < 15%.
  • Objective: a) Is pain reducing effect TENS in responders based on modulation of pain transmission and perception, as measured by CHEPS? b) Is the ability of TENS to modulate pain transmission and perception influenced by abnormal pain processing?
  • Prospective cohort study
  • Patients with chronic non specific pain (duration > 6 months), above 18 year, will be included. Patients are referred from the Pain Clinic of the University Hospital Maastricht (MUMC). Exclusion criteria are: a) pain due to cancer, b) the use of a cardiac pacemaker, c) pregnancy, d) neurological sensory deficits, e) language and/or cognitive inability to complete the health assessment questionnaires f) previous TENS for pain relief.
  • Patients receive a two week treatment period with TENS-treatment, as regular, at home after instruction. The frequency is set at 100 Hz and pulse duration at 250 μ sec. Patients have to use the TENS daily (minimal 4 times a day for 30 minutes).

Main study parameters/endpoints are decrease in amplitude of CHEPS in responders versus non-responders.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with chronic musculoskeltal pain will be recruted from the Pain Clinic of the University Hospital Maastricht (MUMC)
  • Neck Pain
  • Lower Back Pain
  • Shoulder Pain
Device: TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]
Patients are instructed how to use the TENS device during the two weeks at home.Self-adhesive reusable electrodes are used to deliver the electrical stimulation. The frequency is 100 Hz, pulse duration 250 μ sec. Stimulus intensity is strong but not unpleasant. The TENS electrodes are attached proximally and distally around the maximum pain point/area. Patients use TENS 4 times daily (30 minutes each time).
Other Name: TENStemeco Schwa Medico
  • 1
    responders: patients who have a pain reduction of 30% or more after two weeks TENS-treatment
    Intervention: Device: TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]
  • 2
    non-responders: patient who have a pain reduction smaller than 15% after two weeks TENS-treatment
    Intervention: Device: TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
62
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • referred for TENS treatment by a pain physician,
  • duration of pain > 6 months,
  • age above 18,
  • no current other treatment for pain besides pain medication. Patients are allowed to continue their regular pain medication (as described by physician) prior to the TENS treatment

Exclusion Criteria:

  • pain due to cancer,
  • the use of a cardiac pacemaker,
  • pregnancy,
  • neurological sensory deficits,
  • language and/or cognitive inability to complete the health assessment questionnaires
  • previous TENS for pain relief.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00885859
MEC 09-2-025
No
Not Provided
Not Provided
M. van Kleef, MaatrichtUMC
Maastricht University Medical Center
Not Provided
Study Director: Maarten van Kleef, Phd, MD Maastricht University Medical Center
Maastricht University Medical Center
April 2009