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

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.

Study Overview

• Status: Completed
• Conditions: Acute Lumbar Sciatica Secondary to Disc Herniation
• Intervention / Treatment: Procedure: Traction sessions

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67098
    • Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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).

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Marie-Eve ISNER-HOROBETI, MD, Institut Universitaire de Réadaptation Clémenceau - Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 19, 2014

Study Record Updates

• Last Update Posted (Estimate): March 19, 2014
• Last Update Submitted That Met QC Criteria: March 17, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: acute lumbar sciatica, lumbar traction, traction force, radicular pain, lumbar functional parameters, disc herniation
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Sciatica; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: 2754

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No