Failed Back Surgery SyndromeNCT01185665
Predicting Outcome of Transcutaneous Electrical Nerve Stimulator (TENS) in Failed Back Surgery Syndrome
A study testing TENS in people with Failed Back Surgery Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The study investigates the feasibility and efficacy of Transcutaneous Electrical Nerve Stimulator (TENS) in a subgroup of patients with neuropathic pain. Those patients are suffering of neuropathic pain at the lower back and leg after spinal surgery with a predominance of pain in the leg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Sep 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusions:
- Age male/female patient ≥ 18 years
- Patient diagnosed with Failed Back Surgery Syndrome with at least one prior spinal surgery
- Patient with low back pain and/or pain in at least one leg
- Pain intensity at baseline assessed by VAS > 5 (50%)
Who cannot join
- Exclusions:
- Formerly treated with TENS
- Several unrelated sites of pain
- Cognitive impairment
- No help to replace electrodes
- Ongoing litigation
Show all 11Show fewer
- Psychological intervention
- Language difficulties
- No informed consent
- Existing or planned pregnancy
- Age male/female patient <18 years
Trial locations and contacts
1 site in 1 country.
Belgium1 site
UZ Brussel
Brussels, Vlaams Brabant, 1090
Maarten Moens, M.D.
Maarten Moens, MD
About this study
The study investigates the feasibility and efficacy of Transcutaneous Electrical Nerve Stimulator (TENS) in a subgroup of patients with neuropathic pain. Those patients are suffering of neuropathic pain at the lower back and leg after spinal surgery with a predominance of pain in the leg.
Read the detailed description
Derived from folk tradition, the notion that rubbing the skin over a painful area relieves pain, found scientific support in the gate-control theory proposed by Melzack and Wall 1. Since then, electrical stimulations for pain relief have spread worldwide.
The most known technique is Transcutaneous Electrical Nerve Stimulator (TENS). Surface electrodes are placed over the lower back (paravertebral at level L1-L2) it and the stimulation is delivered at high frequency and low intensity (below pain threshold), to produce an intense activation of Ab afferents and to evoke paresthesiae that cover the painful area.
In the literature about TENS in neuropathic pain a few controlled trials (classes II-IV) were found 2-8. The most studies dealt with painful diabetic neuropathy were very-high-frequency stimulation of lower-limb muscles were found more efficacious than standard TENS and low-frequency TENS or acupuncture-like more efficacious than sham stimulations.
Studies dealing with peripheral mononeuropathies found standard TENS better than placebo.
One crossover, small-sample study (class III) in painful cervical radiculopathy found that standard TENS applied to the cervical back was better than placebo but a TENS with random frequency variation was superior7. For chronic back pain no benefit was found for TENS compared to TENS-sham using a VAS and other outcome measures, but benefit was found comparing exercise to no exercise (Class I)9. In another Class I study, TENS vs TENS-sham was studied in patients with multiple sclerosis (MS) and chronic low back pain. After correction for multiple comparisons, there were no significant differences in the VAS or the secondary measures10. Both studies were adequately powered to find at least a 20% difference in pain reduction by VAS between TENS and TENS-sham. But in other articles no benefit were found for chronic back pain treated with TENS11,12. Therefore a recent report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology did not recommend TENS for the treatment of chronic low back pain due to lack of proven efficacy but TENS should be considered for the treatment of painful diabetic neuropathy 13
In our study design, we will investigate the feasibility and efficacy of TENS in a subgroup of patients with neuropathic pain. Those patients are suffering of neuropathic pain at the lower back and leg after spinal surgery with a predominance of pain in the leg.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- TENS, Sham-TENS
- Keywords
- FBSS
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
Transcutaneous Electrical Nerve Stimulator
Sham-TENSDevice
TENS without electrical output, from the outside not different from a normal TENS
| Study group | Role | What they receive |
|---|---|---|
| TENS | Active comparator | FBSS patients treated with TENS Receives: Device: TENS |
| Sham-TENS | Placebo comparator | patients treated with Sham-Tens Receives: Device: Sham-TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility to use TENS devices in Failed Back Surgery Syndrome (FBSS) as a non-invasive method to treat neuropathic pain.
To evaluate the feasibility to use TENS devices in Failed Back Surgery Syndrome (FBSS) as a non-invasive method to treat neuropathic pain using pain scores, QOL scores and depression scores
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Evenepoel Kristof, De Rudder Marc, Dokter Moens Maarten (primary investigator), Prof. dr. Cattrysse Eric, Prof. Dr. D'Haens Jean
- Investigators
- Maarten Moens, M.D., Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185665
- Sponsor's protocol ID
- vubmtmoensTENS
- Status last verified
- Aug 2010
- First submitted
- 19 Aug 2010
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Outcome of Transcutaneous Electrical Nerve Stimulator (TENS) in Failed Back Surgery Syndrome
- ClinicalTrials.gov ID
- NCT01185665
- Acronym / sponsor ID
- vubmtmoensTENS
- Conditions
- Failed Back Surgery Syndrome
- Keywords
- FBSS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Evenepoel Kristof, De Rudder Marc, Dokter Moens Maarten (primary investigator), Prof. dr. Cattrysse Eric, Prof. Dr. D'Haens Jean
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 20 Aug 2010 (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 study investigates the feasibility and efficacy of Transcutaneous Electrical Nerve Stimulator (TENS) in a subgroup of patients with neuropathic pain. Those patients are suffering of neuropathic pain at the lower back and leg after spinal surgery with a predominance of pain in the leg.
Detailed description
Derived from folk tradition, the notion that rubbing the skin over a painful area relieves pain, found scientific support in the gate-control theory proposed by Melzack and Wall 1. Since then, electrical stimulations for pain relief have spread worldwide.
The most known technique is Transcutaneous Electrical Nerve Stimulator (TENS). Surface electrodes are placed over the lower back (paravertebral at level L1-L2) it and the stimulation is delivered at high frequency and low intensity (below pain threshold), to produce an intense activation of Ab afferents and to evoke paresthesiae that cover the painful area.
In the literature about TENS in neuropathic pain a few controlled trials (classes II-IV) were found 2-8. The most studies dealt with painful diabetic neuropathy were very-high-frequency stimulation of lower-limb muscles were found more efficacious than standard TENS and low-frequency TENS or acupuncture-like more efficacious than sham stimulations.
Studies dealing with peripheral mononeuropathies found standard TENS better than placebo.
One crossover, small-sample study (class III) in painful cervical radiculopathy found that standard TENS applied to the cervical back was better than placebo but a TENS with random frequency variation was superior7. For chronic back pain no benefit was found for TENS compared to TENS-sham using a VAS and other outcome measures, but benefit was found comparing exercise to no exercise (Class I)9. In another Class I study, TENS vs TENS-sham was studied in patients with multiple sclerosis (MS) and chronic low back pain. After correction for multiple comparisons, there were no significant differences in the VAS or the secondary measures10. Both studies were adequately powered to find at least a 20% difference in pain reduction by VAS between TENS and TENS-sham. But in other articles no benefit were found for chronic back pain treated with TENS11,12. Therefore a recent report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology did not recommend TENS for the treatment of chronic low back pain due to lack of proven efficacy but TENS should be considered for the treatment of painful diabetic neuropathy 13
In our study design, we will investigate the feasibility and efficacy of TENS in a subgroup of patients with neuropathic pain. Those patients are suffering of neuropathic pain at the lower back and leg after spinal surgery with a predominance of pain in the leg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS | Active comparator | Device: TENSFBSS patients treated with TENS |
| Sham-TENS | Placebo comparator | Device: Sham-TENSpatients treated with Sham-Tens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age male/female patient ≥ 18 years
- Patient diagnosed with Failed Back Surgery Syndrome with at least one prior spinal surgery
- Patient with low back pain and/or pain in at least one leg
- Pain intensity at baseline assessed by VAS > 5 (50%)
Key exclusion criteria (11 listed)
- Formerly treated with TENS
- Several unrelated sites of pain
- Cognitive impairment
- No help to replace electrodes
- Ongoing litigation
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 |
|---|---|---|
| TENSTranscutaneous Electrical Nerve Stimulator | Device | TENS |
| Sham-TENSTENS without electrical output, from the outside not different from a normal TENS | Device | Sham-TENS |
Primary outcome
To evaluate the feasibility to use TENS devices in Failed Back Surgery Syndrome (FBSS) as a non-invasive method to treat neuropathic pain.
Time frame: 1 year
To evaluate the feasibility to use TENS devices in Failed Back Surgery Syndrome (FBSS) as a non-invasive method to treat neuropathic pain using pain scores, QOL scores and depression scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2010.
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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 Moens, M.D. principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Failed Back Surgery Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 5 inclusion and 11 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 20 Aug 2010. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maarten Moens, M.D. (0032478884047, mtmoens@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feasibility to use TENS devices in Failed Back Surgery Syndrome (FBSS) as a non-invasive method to treat neuropathic pain. (time frame: 1 year). 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 20 Aug 2010.