Acute Lumbar Sciatica Secondary to Disc Herniation Clinical Trial
Official title:
High Versus Low Level of Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation
| Verified date | March 2014 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Interventional |
The aim of this study is to compare two levels (high and low forces) of short term lumbar traction on pain and functional tests of the lower limbs in a specific population of patients presenting with acute lumbar sciatica secondary to disc herniation. The investigators hypothesize that, in this particular medical condition, high level of lumbar traction might be more effective than low level lumbar traction in decreasing the pain associated with acute sciatica.
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | September 2006 |
| Est. primary completion date | September 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - less than 6-week lumbar sciatica secondary to disc herniation, confirmed by pain radiating down the leg along the distribution of the sciatic nerve together with positive straight leg raising test (SLRT) Exclusion Criteria: - symptoms persisting for more than 6 weeks - signs of clinical neurological deficit - lumbar sciatica not caused by disc herniation - presence of lumbar tomodensitometry abnormalities - Subjects younger than 18 - pregnant women - patients on medical leave for more than 3 weeks at inclusion - patients with history of lumbar surgery - patients who already had lumbar traction therapy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in radicular pain graduated from 0 to 100 mm | Measurement of radicular pain using a visual analogue scale (VAS) At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up). | No | |
| Secondary | Global mobility of the lumbar-pelvic spine evaluated using the finger to toe test (FTT, in cm) | At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up). | No | |
| Secondary | Lumbar spine mobility (in mm) assessed with the Schöber-Macrae's test | At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up). | No | |
| Secondary | Signs of nerve root compression evaluation assessed by the SLRT and EIFEL score | At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up). | No |