Acute Lumbar Sciatica Secondary to Disc HerniationNCT02091791
High Versus Low Level of Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation
A study testing Traction sessions in people with Acute Lumbar Sciatica Secondary to Disc Herniation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Lumbar Sciatica Secondary to Disc Herniation
- What is being tested?
- Traction sessions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2002to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- patients on medical leave for more than 3 weeks at inclusion
- patients with history of lumbar surgery
- patients who already had lumbar traction therapy
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires
Strasbourg, 67098
About this study
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.
- Being tested
- Traction sessions
- Keywords
- acute lumbar sciatica, lumbar traction, traction force, radicular pain, lumbar functional parameters, disc herniation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traction sessionsProcedure or surgery
Also called Traction sessions using a spinal traction system
| Study group | Role | What they receive |
|---|---|---|
| LT10 | Experimental | Long duration (30 minutes) traction sessions of "low force" (10% of body weight) for 2 weeks (5 sessions/week). Receives: Procedure: Traction sessions |
| LT50 | Experimental | Long duration (30 minutes) traction sessions of "high force" (50% of body weight) for 2 weeks (5 sessions/week). Receives: Procedure: Traction sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radicular pain graduated from 0 to 100 mm
Measured: 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 (3)
Global mobility of the lumbar-pelvic spine evaluated using the finger to toe test (FTT, in cm)
Measured: 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
Measured: 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
Measured: At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startAug 2002
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lumbar Sciatica Secondary to Disc HerniationStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Eve ISNER-HOROBETI, MD, Principal investigator, Institut Universitaire de Réadaptation Clémenceau - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091791
- Sponsor's protocol ID
- 2754
- Status last verified
- Dec 2025
- First submitted
- 13 Mar 2014
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Isner-Horobeti ME, Dufour SP, Schaeffer M, Sauleau E, Vautravers P, Lecocq J, Dupeyron A. High-Force Versus Low-Force Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation: A Preliminary Randomized Trial. J Manipulative Physiol Ther. 2016 Nov-Dec;39(9):645-654. doi: 10.1016/j.jmpt.2016.09.006. Epub 2016 Nov 9.
PubMed 27838140
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Versus Low Level of Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation
- ClinicalTrials.gov ID
- NCT02091791
- Acronym / sponsor ID
- 2754
- Keywords
- acute lumbar sciatica, lumbar traction, traction force, radicular pain, lumbar functional parameters, disc herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LT10 | Experimental | Procedure: Traction sessionsLong duration (30 minutes) traction sessions of "low force" (10% of body weight) for 2 weeks (5 sessions/week). |
| LT50 | Experimental | Procedure: Traction sessionsLong duration (30 minutes) traction sessions of "high force" (50% of body weight) for 2 weeks (5 sessions/week). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traction sessionsAlso: Traction sessions using a spinal traction system | Procedure or surgery | LT10, LT50 |
Primary outcome
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).
3 secondary outcomes
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 27838140Isner-Horobeti ME, Dufour SP, Schaeffer M, Sauleau E, Vautravers P, Lecocq J, Dupeyron A. High-Force Versus Low-Force Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation: A Preliminary Randomized Trial. J Manipulative Physiol Ther. 2016 Nov-Dec;39(9):645-654. doi: 10.1016/j.jmpt.2016.09.006. Epub 2016 Nov 9.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Eve ISNER-HOROBETI, MD principal investigator
Institut Universitaire de Réadaptation Clémenceau - Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traction sessions in people with Acute Lumbar Sciatica Secondary to Disc Herniation, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.