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

NCT ID: NCT00885859

Last Updated: 2009-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2009-12-31

Brief Summary

• 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.

Conditions

Neck Pain; Lower Back Pain; Shoulder Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

responders: patients who have a pain reduction of 30% or more after two weeks TENS-treatment

TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]

Intervention Type: DEVICE

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

TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

TENStemeco Schwa Medico

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

MaatrichtUMC

Principal Investigators

Maarten van Kleef, Phd, MD

Role: STUDY_DIRECTOR

Maastricht University Medical Center

Locations

MaastrichtUMC

Maastricht, Limburg, Netherlands

Countries

Netherlands

Central Contacts

Albere Koke, MSc, PT

Role: CONTACT

a.koke@mumc.nl

+310433877659

Facility Contacts

Albere Koke, Msc, PT

Role: primary

a.koke@mumc.nl

+31433877659

References

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.

Reference Type: BACKGROUND

PMID: 17021587 (View on PubMed)

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. doi: 10.1016/s0304-3940(03)00219-2.

Reference Type: BACKGROUND

PMID: 12727307 (View on PubMed)

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. doi: 10.1186/1746-160X-2-15.

Reference Type: BACKGROUND

PMID: 16725028 (View on PubMed)

Other Identifiers

MEC 09-2-025

Identifier Type: -

Identifier Source: org_study_id