Neck PainNCT00885859
Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Pain, Responders and Non-Responders?
An observational study of Neck Pain and Lower Back Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neck Pain, Lower Back Pain, Shoulder Pain
- What is being tested?
- TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic musculoskeltal pain will be recruted from the Pain Clinic of the University Hospital Maastricht (MUMC)
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
MaastrichtUMC
Maastricht, Limburg, 6202 AZ
Albere Koke, Msc, PT, +31433877659, a.koke@mumc.nl
Maarten Kleef, Phd, MD
About this study
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?
- 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
- Being tested
- TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]
- Medical subject headings
- Neck Pain, Low Back Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]Device
Also called TENStemeco Schwa Medico
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).
| Study group | Role | What they receive |
|---|---|---|
| 1 | responders: patients who have a pain reduction of 30% or more after two weeks TENS-treatment Receives: 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 Receives: Device: TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact heat evoked potentials (CHEPS)
Measured: before and after two weeks treatment
Secondary outcomes (1)
Severity of pijn on average past week(100mm VAS)
Measured: before and after two weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Maarten van Kleef, Phd, MD, Study director, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885859
- Sponsor's protocol ID
- MEC 09-2-025
- Status last verified
- Apr 2009
- First submitted
- 21 Apr 2009
- Last updated
- 22 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17021587de 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.
PubMed 12727307de 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.
PubMed 16725028
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT00885859
- Acronym / sponsor ID
- MEC 09-2-025
- Conditions
- Neck Pain, Lower Back Pain, Shoulder Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]responders: patients who have a pain reduction of 30% or more after two weeks TENS-treatment |
| 2 | – | Device: TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]non-responders: patient who have a pain reduction smaller than 15% after two weeks TENS-treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic musculoskeltal pain will be recruted from the Pain Clinic of the University Hospital Maastricht (MUMC)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENStemeco Schwa Medico [Transcutaneous Electrical Nerve Stimulation (TENS)]Also: TENStemeco Schwa MedicoPatients 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). | Device | 1, 2 |
Primary outcome
Contact heat evoked potentials (CHEPS)
Time frame: before and after two weeks treatment
1 secondary outcome
Severity of pijn on average past week(100mm VAS)
Time frame: before and after two weeks treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2009.
- Background: PubMed 17021587Buonocore 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.
- Background: PubMed 12727307de 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.
- Background: PubMed 16725028de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten van Kleef, Phd, MD study director
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Lower Back Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albere Koke, MSc, PT (+310433877659, a.koke@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contact heat evoked potentials (CHEPS) (time frame: before and after two weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00885859, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2009.