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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Maastricht University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00885859
First received: April 21, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose
  • 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.


Condition Intervention
Neck Pain
Lower Back Pain
Shoulder Pain
Device: TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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?

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Contact heat evoked potentials (CHEPS) [ Time Frame: before and after two weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of pijn on average past week(100mm VAS) [ Time Frame: before and after two weeks treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: June 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
responders: patients who have a pain reduction of 30% or more after two weeks TENS-treatment
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
2
non-responders: patient who have a pain reduction smaller than 15% after two weeks TENS-treatment
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic musculoskeltal pain will be recruted from the Pain Clinic of the University Hospital Maastricht (MUMC)

Criteria

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.
  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: NCT00885859

Contacts
Contact: Albere Koke, MSc, PT +310433877659 a.koke@mumc.nl

Locations
Netherlands
MaastrichtUMC Not yet recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Albere Koke, Msc, PT    +31433877659    a.koke@mumc.nl   
Principal Investigator: Maarten Kleef, Phd, MD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Director: Maarten van Kleef, Phd, MD Maastricht University Medical Center
  More Information

Publications:
Responsible Party: M. van Kleef, MaatrichtUMC
ClinicalTrials.gov Identifier: NCT00885859     History of Changes
Other Study ID Numbers: MEC 09-2-025
Study First Received: April 21, 2009
Last Updated: April 21, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Low Back Pain
Shoulder Pain
Arthralgia
Back Pain
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014