Clinical trial NCT02091791: High Versus Low Level of Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation
Official title: High Versus Low Level of Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lumbar Sciatica Secondary to Disc Herniation
Keywords: acute lumbar sciatica, lumbar traction, traction force, radicular pain, lumbar functional parameters, disc herniation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in radicular pain graduated from 0 to 100 mm
timeFrame: 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).
Secondary outcomes:
measure: Global mobility of the lumbar-pelvic spine evaluated using the finger to toe test (FTT, in cm)
timeFrame: At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up).
measure: Lumbar spine mobility (in mm) assessed with the Schöber-Macrae's test
timeFrame: At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up).
measure: Signs of nerve root compression evaluation assessed by the SLRT and EIFEL score
timeFrame: At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up).
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires
Study officials:
affiliation: Institut Universitaire de Réadaptation Clémenceau - Hôpitaux Universitaires de Strasbourg
name: Marie-Eve ISNER-HOROBETI, MD
role: PRINCIPAL_INVESTIGATOR
References: