Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| lombotens |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | transcutaneous electrical nerve stimulation |
|
| 2 | Placebo Comparator | No transcutaneous electrical nerve stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEFAR PRIMO TENS Class IIA (active) | Device | Active TENS. 4 sessions per day during 3 months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| functional ability | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| pain relief | Week 6 and Month 3 | |
| functional repercussions by Roland scale | Month 3 | |
| functional repercussions by Dallas scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bernard LAURENT, Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Amiens | Amiens | 80000 | France | |||
| CHU de Grenoble |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22337531 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CEFAR PRIMO TENS Class IIA (no active) |
| Device |
Placebo TENS. 4 sessions per day during 3 months. |
|
| Month 3 |
| quality of life | Day 1 and Month 3 |
| global satisfaction of cares | Month 3 |
| medical consumption | From Day 1 to Month 3 |
| TENS observance | from Day 1 to Month 3 |
| Grenoble |
| 38000 |
| France |
| CHU de Limoges | Limoges | 87000 | France |
| Fondation Hôpital Saint Joseph - MARSEILLE | Marseille | 13000 | France |
| La Timone - MARSEILLE | Marseille | 13000 | France |
| Centre Catherine de Sienne - Nantes | Nantes | 44000 | France |
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
| CH de Voiron | Voiron | 38500 | France |