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

Primary Purpose

Acute Lumbar Sciatica Secondary to Disc Herniation

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Traction sessions

About this trial

This is an interventional supportive care trial for Acute Lumbar Sciatica Secondary to Disc Herniation focused on measuring acute lumbar sciatica, lumbar traction, traction force, radicular pain, lumbar functional parameters, disc herniation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

LT10

LT50

Arm Description

Long duration (30 minutes) traction sessions of "low force" (10% of body weight) for 2 weeks (5 sessions/week).

Long duration (30 minutes) traction sessions of "high force" (50% of body weight) for 2 weeks (5 sessions/week).

Outcomes

Primary Outcome Measures

Change in radicular pain graduated from 0 to 100 mm

Secondary Outcome Measures

Global mobility of the lumbar-pelvic spine evaluated using the finger to toe test (FTT, in cm)

Lumbar spine mobility (in mm) assessed with the Schöber-Macrae's test

Signs of nerve root compression evaluation assessed by the SLRT and EIFEL score

Full Information

NCT ID

NCT02091791

First Posted

March 13, 2014

Last Updated

March 17, 2014

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT02091791

Brief Title

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

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

August 2002 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lumbar Sciatica Secondary to Disc Herniation

Keywords

acute lumbar sciatica, lumbar traction, traction force, radicular pain, lumbar functional parameters, disc herniation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LT10

Arm Type

Experimental

Arm Description

Long duration (30 minutes) traction sessions of "low force" (10% of body weight) for 2 weeks (5 sessions/week).

Arm Title

LT50

Arm Type

Experimental

Arm Description

Long duration (30 minutes) traction sessions of "high force" (50% of body weight) for 2 weeks (5 sessions/week).

Intervention Type

Procedure

Intervention Name(s)

Traction sessions

Other Intervention Name(s)

Traction sessions using a spinal traction system

Primary Outcome Measure Information:

Title

Change in radicular pain graduated from 0 to 100 mm

Time Frame

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 Measure Information:

Title

Global mobility of the lumbar-pelvic spine evaluated using the finger to toe test (FTT, in cm)

Time Frame

At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up).

Title

Lumbar spine mobility (in mm) assessed with the Schöber-Macrae's test

Time Frame

At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up).

Title

Signs of nerve root compression evaluation assessed by the SLRT and EIFEL score

Time Frame

At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie-Eve ISNER-HOROBETI, MD

Organizational Affiliation

Institut Universitaire de Réadaptation Clémenceau - Hôpitaux Universitaires de Strasbourg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires

City

Strasbourg

ZIP/Postal Code

67098

Country

France

12. IPD Sharing Statement

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

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