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

Sponsored by:	Maastricht University Medical Center
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00885859

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:	Cohort, 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:

MedlinePlus related topics: Back Pain Neck Injuries and Disorders

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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).
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).

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).

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).

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885859

Contacts

Contact: Albere Koke, MSc, PT

+310433877659

a.koke@mumc.nl

Locations

Netherlands, Limburg
MaastrichtUMC
Maastricht, Limburg, Netherlands, 6202 AZ

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Study Director:

Maarten van Kleef, Phd, MD

Maastricht University Medical Center

More Information

Publications:

Buonocore M, Camuzzini N. Increase of the heat pain threshold during and after high-frequency transcutaneous peripheral nerve stimulation in a group of normal subjects. Eura Medicophys. 2007 Jun;43(2):155-60. Epub 2006 Oct 3.

de Tommaso M, Fiore P, Camporeale A, Guido M, Libro G, Losito L, Megna M, Puca F, Megna G. High and low frequency transcutaneous electrical nerve stimulation inhibits nociceptive responses induced by CO2 laser stimulation in humans. Neurosci Lett. 2003 May 15;342(1-2):17-20.

de Tommaso M, Shevel E, Pecoraro C, Sardaro M, Divenere D, Di Fruscolo O, Lamberti P, Livrea P. Intra-oral orthosis vs amitriptyline in chronic tension-type headache: a clinical and laser evoked potentials study. Head Face Med. 2006 May 25;2:15.

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

Study placed in the following topic categories:

Signs and Symptoms
Musculoskeletal Diseases
Shoulder Pain
Joint Diseases
Neck Pain

Neurologic Manifestations
Low Back Pain
Pain
Arthralgia
Back Pain

Additional relevant MeSH terms:

Signs and Symptoms
Musculoskeletal Diseases
Shoulder Pain
Joint Diseases
Nervous System Diseases
Neck Pain

Neurologic Manifestations
Low Back Pain
Pain
Arthralgia
Back Pain

ClinicalTrials.gov processed this record on August 24, 2009