Chronic Low Back PainPhase 4LOBOTENSNCT00452010
Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-radiculalgia
A Phase 4 study testing CEFAR PRIMO TENS Class IIA (active) and CEFAR PRIMO TENS Class IIA (no active) in people with Chronic Low Back Pain and Chronic Lumbo-radiculalgia, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
Trial summary
Prior studies showed contradictory results about the best type of TENS in chronic pain pathology. Therefore we want to evaluate the efficacy assessment of TENS on patients with chronic low back pain or chronic lumbo-radiculalgia. The functional ability score is evaluated by the Roland scale at 6 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain, Chronic Lumbo-radiculalgia
- What is being tested?
- CEFAR PRIMO TENS Class IIA (active) and CEFAR PRIMO TENS Class IIA (no active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 8 sitesFrance
- Study dates
- Sep 2006to Sep 2008
- Phase
- Phase 4
- 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
- Stable chronic low back pain or stable chronic lumbo-radiculalgia
- Patients with a pain score at least superior or equal to 4
- Patients followed in pain clinics
- Written informed consent
Who cannot join
- Prior ambulatory TENS practice
- Lumbo-radiculalgia pathology surgery within 3 months before inclusion
- Acute low back pain or bilateral lumbo-radiculalgia
- Acute radiculalgia
- Surgery planned within 6 months
- Pacemaker
- Symptomatic low back pain
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU d'Amiens
Amiens, 80000
CHU de Grenoble
Grenoble, 38000
CHU de Limoges
Limoges, 87000
Fondation Hôpital Saint Joseph - MARSEILLE
Marseille, 13000
La Timone - MARSEILLE
Marseille, 13000
Centre Catherine de Sienne - Nantes
Nantes, 44000
CHU de Saint-Etienne
Saint-Etienne, 42055
CH de Voiron
Voiron, 38500
About this study
Official title: Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Chronic Low Back Pain or Chronic Lumbo-radiculalgia and Followed in Pain Treatment Centers
Prior studies showed contradictory results about the best type of TENS in chronic pain pathology.
Therefore we want to evaluate the efficacy assessment of TENS on patients with chronic low back pain or chronic lumbo-radiculalgia.
The functional ability score is evaluated by the Roland scale at 6 weeks.
- Conditions
- Chronic Low Back Pain, Chronic Lumbo-radiculalgia
- Being tested
- CEFAR PRIMO TENS Class IIA (active), CEFAR PRIMO TENS Class IIA (no active)
- Keywords
- TENS, chronic low back pain, chronic lumbo-radiculalgia, placebo, Roland scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEFAR PRIMO TENS Class IIA (active)Device
Active TENS. 4 sessions per day during 3 months.
CEFAR PRIMO TENS Class IIA (no active)Device
Placebo TENS. 4 sessions per day during 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | transcutaneous electrical nerve stimulation Receives: Device: CEFAR PRIMO TENS Class IIA (active) |
| 2 | Placebo comparator | No transcutaneous electrical nerve stimulation Receives: Device: CEFAR PRIMO TENS Class IIA (no active) |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional ability
Measured: Week 6
Secondary outcomes (7)
pain relief
Measured: Week 6 and Month 3
functional repercussions by Roland scale
Measured: Month 3
functional repercussions by Dallas scale
Measured: Month 3
quality of life
Measured: Day 1 and Month 3
global satisfaction of cares
Measured: Month 3
medical consumption
Measured: From Day 1 to Month 3
TENS observance
Measured: from Day 1 to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2007 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Investigators
- Bernard LAURENT, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452010
- Sponsor's protocol ID
- 0601001
- Other IDs
- lombotens
- Acronym
- LOBOTENS
- Status last verified
- Sep 2008
- First submitted
- 23 Mar 2007
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Buchmuller A, Navez M, Milletre-Bernardin M, Pouplin S, Presles E, Lanteri-Minet M, Tardy B, Laurent B, Camdessanche JP; Lombotens Trial Group. Value of TENS for relief of chronic low back pain with or without radicular pain. Eur J Pain. 2012 May;16(5):656-65. doi: 10.1002/j.1532-2149.2011.00061.x. Epub 2011 Dec 20.
PubMed 22337531
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Chronic Low Back Pain or Chronic Lumbo-radiculalgia and Followed in Pain Treatment Centers
- ClinicalTrials.gov ID
- NCT00452010
- Acronym / sponsor ID
- LOBOTENS / 0601001
- Conditions
- Chronic Low Back Pain, Chronic Lumbo-radiculalgia
- Keywords
- TENS, chronic low back pain, chronic lumbo-radiculalgia, placebo, Roland scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 26 Mar 2007 (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.
Prior studies showed contradictory results about the best type of TENS in chronic pain pathology.
Therefore we want to evaluate the efficacy assessment of TENS on patients with chronic low back pain or chronic lumbo-radiculalgia.
The functional ability score is evaluated by the Roland scale at 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CEFAR PRIMO TENS Class IIA (active)transcutaneous electrical nerve stimulation |
| 2 | Placebo comparator | Device: CEFAR PRIMO TENS Class IIA (no active)No transcutaneous electrical nerve stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable chronic low back pain or stable chronic lumbo-radiculalgia
- Patients with a pain score at least superior or equal to 4
- Patients followed in pain clinics
- Written informed consent
Key exclusion criteria (7 listed)
- Prior ambulatory TENS practice
- Lumbo-radiculalgia pathology surgery within 3 months before inclusion
- Acute low back pain or bilateral lumbo-radiculalgia
- Acute radiculalgia
- Surgery planned within 6 months
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 |
|---|---|---|
| CEFAR PRIMO TENS Class IIA (active)Active TENS. 4 sessions per day during 3 months. | Device | 1 |
| CEFAR PRIMO TENS Class IIA (no active)Placebo TENS. 4 sessions per day during 3 months. | Device | 2 |
Primary outcome
functional ability
Time frame: Week 6
7 secondary outcomes
pain relief
Time frame: Week 6 and Month 3
functional repercussions by Roland scale
Time frame: Month 3
functional repercussions by Dallas scale
Time frame: Month 3
quality of life
Time frame: Day 1 and Month 3
global satisfaction of cares
Time frame: Month 3
medical consumption
Time frame: From Day 1 to Month 3
TENS observance
Time frame: from Day 1 to Month 3
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 4 Jul 2012.
- Results publication: PubMed 22337531Buchmuller A, Navez M, Milletre-Bernardin M, Pouplin S, Presles E, Lanteri-Minet M, Tardy B, Laurent B, Camdessanche JP; Lombotens Trial Group. Value of TENS for relief of chronic low back pain with or without radicular pain. Eur J Pain. 2012 May;16(5):656-65. doi: 10.1002/j.1532-2149.2011.00061.x. Epub 2011 Dec 20.
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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.
Bernard LAURENT, Professor principal investigator
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CEFAR PRIMO TENS Class IIA (active) and CEFAR PRIMO TENS Class IIA (no active) in people with Chronic Low Back Pain and Chronic Lumbo-radiculalgia, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
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 7 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 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
functional ability (time frame: Week 6). 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 NCT00452010, which also lists 1 linked publication.
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 4 Jul 2012.