Low Back PainNCT03453775
Ultrasound-guided Lumbar Periradicular Injection: a Non Irradiating Infiltration Technique
A study testing Ultrasound guided periradicular lumbar infiltration and Fluoroscopy guided periradicular lumbar infiltration in people with Low Back Pain and Sciatica, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
We propose here to evaluate the precision of lumbar periradicular infiltration performed under a transverse ultrasound approach by performing a fluoroscopic control once the needle in the desired position. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain, Sciatica, Disc, Herniated
- What is being tested?
- Ultrasound guided periradicular lumbar infiltration and Fluoroscopy guided periradicular lumbar infiltration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Feb 2018to 30 May 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- neurology, neurosurgery, physical medicine, algology consultation
- over the age of 18
- Radiculalgia in the territory corresponding to the root lesion
- Symptomatology inferior to two months.
- Imaging (CT scan or MRI) or electromyographic study with evidence (foraminal disc herniation or foraminal stenosis) of the irritation or the causal compression of the radicular symptomatology
Who cannot join
- allergy to any of the constituents of the infiltrated product, or to the contrast medium
- unstable medical condition: cardiac, respiratory, endocrine (uncontrolled diabetes)
- inability to put himself in a prone position
- depression: HADS score equal to or greater than 11.
- root lesion caused by an accident at work, a tumoral or infectious causal process.
- local infection (cutaneous, perimedullary / spinal) or systemic
Show all 11Show fewer
- coagulopathy (platelets <50000 / mm3, Prothrombin time <60%, INTernational normalized ratio> 1.5), anticoagulant or antiplatelet therapy treatment other than aspirin
- Lumbar surgical history
- history of foraminal or perimedullary infiltration of less than 6 months
- symptoms older than two months
- pregnant woman
Trial locations and contacts
1 site in 1 country.
Van Obbergh contact
Belgium1 site, 1 recruiting
- Recruiting
Hopital Erasme
Anderlecht, Brussels Capital, 1070
+3225553111
About this study
Official title: Ultrasound-guided Lumbar Periradicular Injection: Effectiveness and Benefits of a Non Irradiating Infiltration Technique. A Randomized Controlled Trial
We propose here to evaluate the precision of lumbar periradicular infiltration performed under a transverse ultrasound approach by performing a fluoroscopic control once the needle in the desired position. The effectiveness of the technique will be assessed by measuring different pain and disability scores at four weeks post-infiltration: the Visual analogue pain Scale score, the DN4 score, and the Oswestry disability score (ODI); The decrease in irradiation received will be collected, compared to that of the conventional fluoroscopic technique.
Read the detailed description
Foraminal periradicular infiltrations for therapeutic purposes are currently recognized as an integral part of the treatment of radiculalgia, particularly in case of radiculalgia refractory to a well-conducted initial treatment, in combination with the rehabilitation and education of the patient. The incidence of low back pain, lumbar pain or pure radiculalgia in the general population is very high. In fact, the majority of people will experience at least once in their life low back pain or neck pain, favored by the growing aging of the population. This leads us to propose infiltrative techniques more and more modern, as much in the technique performed as in the type of medication used, presenting the best risk / benefit ratio. Infiltrations guided by imaging tend to become less and less "invasive", with the undeniable contribution of ultrasound as a major tool in the diagnostic and therapeutic approaches, both in specialized pain management clinic as in other medical specialties. To date, infiltrations are still mostly performed under fluoroscopic control by injection of contrast medium (epidurography), or under CT control, where the identification of the anatomical structures and therefore the target allows a greater accuracy of the level of infiltration. These two techniques have proven their effectiveness, but have significant disadvantages, such as the irradiation of the patient as well as that of the practitioner because of the number of daily acts performed; their cost, and the need for a radiologist in the case of a CT technique. For its part, ultrasound is easily available, easy to use, represents a lower cost, and the lack of irradiation.
In recent years ultrasound has proved effective in identifying anatomical structures of the spine and in the techniques of lumbar periradicular infiltration, whether performed in sagittal paramedian or oblique sagittal paramedian, the latter having shown a better intra-foraminal distribution of the injected product. (39.5% vs 87.5% in terms of intraforaminal diffusion of the contrast medium). In addition, teams have shown the superiority of ultrasound-guided lumbar foraminal infiltration compared with CT control in terms of time spent on infiltration, for exact accuracy in 90% of patients, and an improvement in radiculalgia at 1 month similar between the two techniques.
We propose here to evaluate the precision of lumbar periradicular infiltration performed under a transverse ultrasound approach by performing a fluoroscopic control once the needle in the desired position. The effectiveness of the technique will be assessed by measuring different pain and disability scores at four weeks post-infiltration: the Visual analogue pain scale score, the DN4 score, and the Oswestry disability score (ODI); The decrease in irradiation received will be collected, compared to that of the conventional fluoroscopic technique.
- Conditions
- Low Back Pain, Sciatica, Disc, Herniated, Foraminal Hernia, Lumbar Foraminal Stenosis, Chronic Low Back Pain
- Being tested
- Ultrasound guided periradicular lumbar infiltration, Fluoroscopy guided periradicular lumbar infiltration
- Medical subject headings
- Low Back Pain, Sciatica, Intervertebral Disc Displacement, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided periradicular lumbar infiltrationDevice
Once position of the needle is confirmed, the mixture Depomedrol 40mg + Lidocaine 2% (1ml) is injected, under neurostimulation with an intensity of 0.2 milliampere (identifies a distance of 1mm from the nerve root allowing the protection of the root of a lesion by the needle).
Fluoroscopy guided periradicular lumbar infiltrationDevice
Once position of the needle is confirmed, the mixture Depomedrol 40mg + Lidocaine 2% (1ml) is injected, under neurostimulation with an intensity of 0.2 milliampere (identifies a distance of 1mm from the nerve root allowing the protection of the root of a lesion by the needle).
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided infiltration | Active comparator | Ultrasound guided periradicular lumbar infiltration. Prone position. Lumbar spine level located in a median sagittal plane (spinous processes). High resolution curved 5MHz ultrasound probe. Probe is then rotated 90° for a median transverse image. Transverse plane translation towards desired side to have in the same plane: spinous process, vertebral blade, zygapophysial articulation, lateral facet, transverse process. Needle passes skin at 45° angle, directed "in plane" to the foramen. Fluoroscopy then performed to check needle's correct position. Poorly positioned needles will be replaced to obtain an intra-foraminal/epidural periradicular diffusion of the contrast medium. Once position is confirmed, Depomedrol 40mg + lidocaine 2% (1ml) is injected. Receives: Device: Ultrasound guided periradicular lumbar infiltration |
| Fluoroscopy guided infiltration | Active comparator | Fluoroscopy guided periradicular lumbar infiltration. Prone position. Anatomical identification by radioscopy: antero-posterior and sagittal planes. Needle placement in an anteroposterior view, needle is then advanced in an inclined plane of 20° with respect to the initial axis, "tunnel vision" type image. Foramen is then reached in a sagittal view (not to progress too far in the intra-foraminal level). Needle progression is secured by neurostimulation (territory concerned by the root, intensity 0.2 milliampere to be at a distance of 1mm from the nerve root). Once needle is in place, fluoroscopy is performed to verify correct positioning (Omnipaque 300mg/ml of Iohexol, 0.2 to 0.5ml). Once position confirmed, mixture Depomedrol 40mg + lidocaine 2% (1ml) is injected. Receives: Device: Fluoroscopy guided periradicular lumbar infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of needle placement under ultrasound guidance
Good position: G. Wrong position: W.
Measured: Before infiltration
Secondary outcomes (4)
Irradiation doses
centiGray. Radioscopy irradiation doses will be calculated in each procedure, to determine how efficient the ultrasound approach is, compared to fluoroscopy only.
Measured: 24h
Visual analogue scale
0/10 (minimum) to 10/10 (maximum)
Measured: Baseline, 2weeks, 4weeks
Neuropathic pain score: DN4
Score /10
Measured: Baseline, 2 weeks, 4 weeks
Oswestry Disability index
% out of 50 questions (0/50= 0% to 50/50=100%)
Measured: Baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start27 Feb 2018
- Primary completion30 Apr 2018 (estimated)
- Study completion30 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, open trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Gruson, Université Libre de Bruxelles
- Investigators
- Van Obbergh, Study director, Chief of staff Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453775
- Sponsor's protocol ID
- P2018/047
- Status last verified
- Apr 2018
- First submitted
- 16 Jan 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gangi A, Dietemann JL, Mortazavi R, Pfleger D, Kauff C, Roy C. CT-guided interventional procedures for pain management in the lumbosacral spine. Radiographics. 1998 May-Jun;18(3):621-33. doi: 10.1148/radiographics.18.3.9599387.
PubMed 9599387Galiano K, Obwegeser AA, Bodner G, Freund M, Maurer H, Kamelger FS, Schatzer R, Ploner F. Real-time sonographic imaging for periradicular injections in the lumbar spine: a sonographic anatomic study of a new technique. J Ultrasound Med. 2005 Jan;24(1):33-8. doi: 10.7863/jum.2005.24.1.33.
PubMed 15615926Obernauer J, Galiano K, Gruber H, Bale R, Obwegeser AA, Schatzer R, Loizides A. Ultrasound-guided versus computed tomography-controlled periradicular injections in the middle and lower cervical spine: a prospective randomized clinical trial. Eur Spine J. 2013 Nov;22(11):2532-7. doi: 10.1007/s00586-013-2916-0. Epub 2013 Jul 23.
PubMed 23877110Gofeld M, Bristow SJ, Chiu SC, McQueen CK, Bollag L. Ultrasound-guided lumbar transforaminal injections: feasibility and validation study. Spine (Phila Pa 1976). 2012 Apr 20;37(9):808-12. doi: 10.1097/BRS.0b013e3182340096.
PubMed 21912311Kim YH, Park HJ, Moon DE. Ultrasound-guided Pararadicular Injection in the Lumbar Spine: A Comparative Study of the Paramedian Sagittal and Paramedian Sagittal Oblique Approaches. Pain Pract. 2015 Nov;15(8):693-700. doi: 10.1111/papr.12249. Epub 2014 Oct 14.
PubMed 25313534
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Lumbar Periradicular Injection: Effectiveness and Benefits of a Non Irradiating Infiltration Technique. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03453775
- Acronym / sponsor ID
- P2018/047
- Conditions
- Low Back Pain, Sciatica, Disc, Herniated, Foraminal Hernia, Lumbar Foraminal Stenosis, Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 5 Mar 2018 (actual)
- 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.
We propose here to evaluate the precision of lumbar periradicular infiltration performed under a transverse ultrasound approach by performing a fluoroscopic control once the needle in the desired position. The effectiveness of the technique will be assessed by measuring different pain and disability scores at four weeks post-infiltration: the Visual analogue pain Scale score, the DN4 score, and the Oswestry disability score (ODI); The decrease in irradiation received will be collected, compared to that of the conventional fluoroscopic technique.
Detailed description
Foraminal periradicular infiltrations for therapeutic purposes are currently recognized as an integral part of the treatment of radiculalgia, particularly in case of radiculalgia refractory to a well-conducted initial treatment, in combination with the rehabilitation and education of the patient. The incidence of low back pain, lumbar pain or pure radiculalgia in the general population is very high. In fact, the majority of people will experience at least once in their life low back pain or neck pain, favored by the growing aging of the population. This leads us to propose infiltrative techniques more and more modern, as much in the technique performed as in the type of medication used, presenting the best risk / benefit ratio. Infiltrations guided by imaging tend to become less and less "invasive", with the undeniable contribution of ultrasound as a major tool in the diagnostic and therapeutic approaches, both in specialized pain management clinic as in other medical specialties. To date, infiltrations are still mostly performed under fluoroscopic control by injection of contrast medium (epidurography), or under CT control, where the identification of the anatomical structures and therefore the target allows a greater accuracy of the level of infiltration. These two techniques have proven their effectiveness, but have significant disadvantages, such as the irradiation of the patient as well as that of the practitioner because of the number of daily acts performed; their cost, and the need for a radiologist in the case of a CT technique. For its part, ultrasound is easily available, easy to use, represents a lower cost, and the lack of irradiation.
In recent years ultrasound has proved effective in identifying anatomical structures of the spine and in the techniques of lumbar periradicular infiltration, whether performed in sagittal paramedian or oblique sagittal paramedian, the latter having shown a better intra-foraminal distribution of the injected product. (39.5% vs 87.5% in terms of intraforaminal diffusion of the contrast medium). In addition, teams have shown the superiority of ultrasound-guided lumbar foraminal infiltration compared with CT control in terms of time spent on infiltration, for exact accuracy in 90% of patients, and an improvement in radiculalgia at 1 month similar between the two techniques.
We propose here to evaluate the precision of lumbar periradicular infiltration performed under a transverse ultrasound approach by performing a fluoroscopic control once the needle in the desired position. The effectiveness of the technique will be assessed by measuring different pain and disability scores at four weeks post-infiltration: the Visual analogue pain scale score, the DN4 score, and the Oswestry disability score (ODI); The decrease in irradiation received will be collected, compared to that of the conventional fluoroscopic technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, open trial
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided infiltration | Active comparator | Device: Ultrasound guided periradicular lumbar infiltrationUltrasound guided periradicular lumbar infiltration. Prone position. Lumbar spine level located in a median sagittal plane (spinous processes). High resolution curved 5MHz ultrasound probe. Probe is then rotated 90° for a median transverse image. Transverse plane translation towards desired side to have in the same plane: spinous process, vertebral blade, zygapophysial articulation, lateral facet, transverse process. Needle passes skin at 45° angle, directed "in plane" to the foramen. Fluoroscopy then performed to check needle's correct position. Poorly positioned needles will be replaced to obtain an intra-foraminal/epidural periradicular diffusion of the contrast medium. Once position is confirmed, Depomedrol 40mg + lidocaine 2% (1ml) is injected. |
| Fluoroscopy guided infiltration | Active comparator | Device: Fluoroscopy guided periradicular lumbar infiltrationFluoroscopy guided periradicular lumbar infiltration. Prone position. Anatomical identification by radioscopy: antero-posterior and sagittal planes. Needle placement in an anteroposterior view, needle is then advanced in an inclined plane of 20° with respect to the initial axis, "tunnel vision" type image. Foramen is then reached in a sagittal view (not to progress too far in the intra-foraminal level). Needle progression is secured by neurostimulation (territory concerned by the root, intensity 0.2 milliampere to be at a distance of 1mm from the nerve root). Once needle is in place, fluoroscopy is performed to verify correct positioning (Omnipaque 300mg/ml of Iohexol, 0.2 to 0.5ml). Once position confirmed, mixture Depomedrol 40mg + lidocaine 2% (1ml) is injected. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- neurology, neurosurgery, physical medicine, algology consultation
- over the age of 18
- Radiculalgia in the territory corresponding to the root lesion
- Symptomatology inferior to two months.
- Imaging (CT scan or MRI) or electromyographic study with evidence (foraminal disc herniation or foraminal stenosis) of the irritation or the causal compression of the radicular symptomatology
Key exclusion criteria (11 listed)
- allergy to any of the constituents of the infiltrated product, or to the contrast medium
- unstable medical condition: cardiac, respiratory, endocrine (uncontrolled diabetes)
- inability to put himself in a prone position
- depression: HADS score equal to or greater than 11.
- root lesion caused by an accident at work, a tumoral or infectious causal process.
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 |
|---|---|---|
| Ultrasound guided periradicular lumbar infiltrationOnce position of the needle is confirmed, the mixture Depomedrol 40mg + Lidocaine 2% (1ml) is injected, under neurostimulation with an intensity of 0.2 milliampere (identifies a distance of 1mm from the nerve root allowing the protection of the root of a lesion by the needle). | Device | Ultrasound guided infiltration |
| Fluoroscopy guided periradicular lumbar infiltrationOnce position of the needle is confirmed, the mixture Depomedrol 40mg + Lidocaine 2% (1ml) is injected, under neurostimulation with an intensity of 0.2 milliampere (identifies a distance of 1mm from the nerve root allowing the protection of the root of a lesion by the needle). | Device | Fluoroscopy guided infiltration |
Primary outcome
Effectiveness of needle placement under ultrasound guidance
Time frame: Before infiltration
Good position: G. Wrong position: W.
4 secondary outcomes
Irradiation doses
Time frame: 24h
Visual analogue scale
Time frame: Baseline, 2weeks, 4weeks
Neuropathic pain score: DN4
Time frame: Baseline, 2 weeks, 4 weeks
Oswestry Disability index
Time frame: Baseline, 2 weeks, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Results publication: PubMed 9599387Gangi A, Dietemann JL, Mortazavi R, Pfleger D, Kauff C, Roy C. CT-guided interventional procedures for pain management in the lumbosacral spine. Radiographics. 1998 May-Jun;18(3):621-33. doi: 10.1148/radiographics.18.3.9599387.
- Results publication: PubMed 15615926Galiano K, Obwegeser AA, Bodner G, Freund M, Maurer H, Kamelger FS, Schatzer R, Ploner F. Real-time sonographic imaging for periradicular injections in the lumbar spine: a sonographic anatomic study of a new technique. J Ultrasound Med. 2005 Jan;24(1):33-8. doi: 10.7863/jum.2005.24.1.33.
- Results publication: PubMed 23877110Obernauer J, Galiano K, Gruber H, Bale R, Obwegeser AA, Schatzer R, Loizides A. Ultrasound-guided versus computed tomography-controlled periradicular injections in the middle and lower cervical spine: a prospective randomized clinical trial. Eur Spine J. 2013 Nov;22(11):2532-7. doi: 10.1007/s00586-013-2916-0. Epub 2013 Jul 23.
- Results publication: PubMed 21912311Gofeld M, Bristow SJ, Chiu SC, McQueen CK, Bollag L. Ultrasound-guided lumbar transforaminal injections: feasibility and validation study. Spine (Phila Pa 1976). 2012 Apr 20;37(9):808-12. doi: 10.1097/BRS.0b013e3182340096.
- Results publication: PubMed 25313534Kim YH, Park HJ, Moon DE. Ultrasound-guided Pararadicular Injection in the Lumbar Spine: A Comparative Study of the Paramedian Sagittal and Paramedian Sagittal Oblique Approaches. Pain Pract. 2015 Nov;15(8):693-700. doi: 10.1111/papr.12249. Epub 2014 Oct 14.
- Individual participant dataSharing planned: No
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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.
Van Obbergh contact
Van Obbergh study director
Chief of staff Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided periradicular lumbar infiltration and Fluoroscopy guided periradicular lumbar infiltration in people with Low Back Pain and Sciatica, run by Université Libre de Bruxelles at 1 site in Belgium.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 10 Apr 2018. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gruson (0032 2 555 5850, paulgruson.dr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of needle placement under ultrasound guidance (time frame: Before infiltration). 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 NCT03453775, which also lists 5 linked publications.
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 10 Apr 2018.