Neuropathic PainNCT00716326
The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin
A study testing Transcutaneous Nerve Stimulation (TENS) and Cefar Primo Pro TENS device in people with Neuropathic Pain, run by Norwegian Fund for Postgraduate Training in Physiotherapy at 1 site in Norway.
Trial summary
The aim of this study is to investigate the effectiveness of TENS in addition to routine care in patients with chronic pain of predominantly neuropathic origin, compared to treatment with routine care alone." Hypothesis: An eventually neuropathic pain component is needed to be identified and alleviated in chronic pain… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Transcutaneous Nerve Stimulation (TENS) and Cefar Primo Pro TENS device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2007to Dec 2008
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with chronic pain of predominantly neuropathic origin
Who cannot join
- Pain less than 3 months
- Surgery or lesion within 3 months
- Central neuropathic pain
- Fibromyalgia
- Primary headaches
- Primary psychiatric diagnosis
- Patients with pacemaker
- Formerly treated with TENS
Trial locations and contacts
1 site in 1 country.
Norway1 site
Skogli helse- og rehabiliteringssenter
Lillehammer, Lillehammer, 2614
About this study
The aim of this study is to investigate the effectiveness of TENS in addition to routine care in patients with chronic pain of predominantly neuropathic origin, compared to treatment with routine care alone."
Hypothesis:
An eventually neuropathic pain component is needed to be identified and alleviated in chronic pain patients to improve the quality of rehabilitation.
0-hypothesis:
- TENS is not better than than placebo, medication or standard rehabilitation program.
- A neuropathic pain component does not demand special considerations in rehabilitation of chronic pain patients.
Read the detailed description
Setting:
Skogli helse- og rehabiliteringssenter, Lillehammer, Norway. Center of Rehabilitation for chronic pain patients, rheumatic diseases and orthopedic postoperative patients.
Duration:
Until 18 months of intervention + 6 months of follow up and preparation.
Intervention:
Use of TENS during 3-4 weeks of hospitalization connected to multimodal rehabilitation (short-term efficacy). TENS or placebo-TENS is added to routine care.
Follow-up:
If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to borrow equipment for 4 months. Questionnaires will be send at 2 and 4 months, both for the active group, the placebo group and for the group of patients who discontinued the use of TENS/placebo-TENS (long-term efficacy).
- Conditions
- Neuropathic Pain
- Being tested
- Transcutaneous Nerve Stimulation (TENS), Cefar Primo Pro TENS device
- Keywords
- Transcutaneous Electrical Nerve Stimulation, Chronic pain, Neuropathic pain, Short-term efficacy, Long-term efficacy
- Medical subject headings
- Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Nerve Stimulation (TENS)Device
Patients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises. The TENS will be used during 3-4 weeks of hospitalization. If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to borrow equipment for 4 months.
Cefar Primo Pro TENS deviceDevice
Patients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises.
Active TENS: high-frequency modulated pulse duration stimulation Placebo TENS: manipulated device with impulses near sensory threshold.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subjects in this study arm will receive active treatment with Cefar TENS device which delivers therapeutic electrical currents 2-3x over sensory threshold in the area of pain. Receives: Device: Transcutaneous Nerve Stimulation (TENS); Device: Cefar Primo Pro TENS device |
| 2 | Placebo comparator | Subjects in this study arm will receive placebo treatment with manipulated Cefar TENS device which delivers electrical currents just below sensory threshold in the area of pain. Receives: Device: Cefar Primo Pro TENS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pain and/or functional improvement
Measured: 3-4 weeks, 2 and 4 months
Secondary outcomes (1)
Compliance. Patient global impression of change
Measured: 3-4 weeks, 2 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Sponsor type
- University, hospital or other
- Investigators
- Jan M Bjordal, professor, Study director, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716326
- Sponsor's protocol ID
- 8589 (REK)
- Other IDs
- 15602 (NSD), 408/06-301.0 (Fondet)
- Status last verified
- Dec 2008
- First submitted
- 9 Jul 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin
- ClinicalTrials.gov ID
- NCT00716326
- Acronym / sponsor ID
- 8589 (REK)
- Conditions
- Neuropathic Pain
- Keywords
- Transcutaneous Electrical Nerve Stimulation, Chronic pain, Neuropathic pain, Short-term efficacy, Long-term efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Norwegian Fund for Postgraduate Training in PhysiotherapyUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Jul 2008 (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.
The aim of this study is to investigate the effectiveness of TENS in addition to routine care in patients with chronic pain of predominantly neuropathic origin, compared to treatment with routine care alone."
Hypothesis:
An eventually neuropathic pain component is needed to be identified and alleviated in chronic pain patients to improve the quality of rehabilitation.
0-hypothesis:
- TENS is not better than than placebo, medication or standard rehabilitation program.
- A neuropathic pain component does not demand special considerations in rehabilitation of chronic pain patients.
Detailed description
Setting:
Skogli helse- og rehabiliteringssenter, Lillehammer, Norway. Center of Rehabilitation for chronic pain patients, rheumatic diseases and orthopedic postoperative patients.
Duration:
Until 18 months of intervention + 6 months of follow up and preparation.
Intervention:
Use of TENS during 3-4 weeks of hospitalization connected to multimodal rehabilitation (short-term efficacy). TENS or placebo-TENS is added to routine care.
Follow-up:
If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to borrow equipment for 4 months. Questionnaires will be send at 2 and 4 months, both for the active group, the placebo group and for the group of patients who discontinued the use of TENS/placebo-TENS (long-term efficacy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Transcutaneous Nerve Stimulation (TENS), Device: Cefar Primo Pro TENS deviceSubjects in this study arm will receive active treatment with Cefar TENS device which delivers therapeutic electrical currents 2-3x over sensory threshold in the area of pain. |
| 2 | Placebo comparator | Device: Cefar Primo Pro TENS deviceSubjects in this study arm will receive placebo treatment with manipulated Cefar TENS device which delivers electrical currents just below sensory threshold in the area of pain. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with chronic pain of predominantly neuropathic origin
Key exclusion criteria (8 listed)
- Pain less than 3 months
- Surgery or lesion within 3 months
- Central neuropathic pain
- Fibromyalgia
- Primary headaches
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 |
|---|---|---|
| Transcutaneous Nerve Stimulation (TENS)Patients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises. The TENS will be used during 3-4 weeks of hospitalization. If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to borrow equipment for 4 months. | Device | 1 |
| Cefar Primo Pro TENS devicePatients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises. Active TENS: high-frequency modulated pulse duration stimulation Placebo TENS: manipulated device with impulses near sensory threshold. | Device | 1, 2 |
Primary outcome
Reduction of pain and/or functional improvement
Time frame: 3-4 weeks, 2 and 4 months
1 secondary outcome
Compliance. Patient global impression of change
Time frame: 3-4 weeks, 2 and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2008.
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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.
Jan M Bjordal, professor study director
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Nerve Stimulation (TENS) and Cefar Primo Pro TENS device in people with Neuropathic Pain, run by Norwegian Fund for Postgraduate Training in Physiotherapy at 1 site in Norway.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 18 Dec 2008. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of pain and/or functional improvement (time frame: 3-4 weeks, 2 and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2008.