High Versus Low Level of Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation

Study Overview
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Brief Summary
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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.

Official Title
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High Versus Low Level of Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation

Conditions
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Acute Lumbar Sciatica Secondary to Disc Herniation

Intervention / Treatment
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* Procedure: Traction sessions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LT10<br>Long duration (30 minutes) traction sessions of low force (10% of body weight) for 2 weeks (5 sessions/week). | Procedure: Traction sessions<br> <br> * Other names: Traction sessions using a spinal traction system;|
| Experimental: LT50<br>Long duration (30 minutes) traction sessions of high force (50% of body weight) for 2 weeks (5 sessions/week). | Procedure: Traction sessions<br> <br> * Other names: Traction sessions using a spinal traction system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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). | 
| 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute lumbar sciatica, lumbar traction, traction force, radicular pain, lumbar functional parameters, disc herniation