Chronic Low-back PainNCT04658953
Comparison of the Effectiveness of Ultrasound-guided Versus Radioguided Medial Lumbar Bundle Branch Block
A study testing Ultrasound guided infiltration and Fluoroscopy guided infiltration in people with Chronic Low-back Pain and Lumbar Facet Joint Syndrome, run by Centre Hospitalier Universitaire Saint Pierre at 3 sites in Belgium.
Trial summary
In adults with chronic low back pain, the investigators will compare the effectiveness of the medial bundle branch block on three lumbar levels (L3-L4, L4-L5 and L5-S1) performed either by radiographic guidance or by ultrasound approach according to a transverse approach. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Low-back Pain, Lumbar Facet Joint Syndrome
- What is being tested?
- Ultrasound guided infiltration and Fluoroscopy guided infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesBelgium
- Study dates
- 6 Jan 2021to 10 Mar 2022
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Low-back pain for at least 3 months, without response to a conservative treatment of minimum 4 weeks
- No signs of dissociated pain, radiculitis, neurological diseases (including stroke, Parkinson's disease), spinal instability or deformities (such as scoliosis, ankylosing spondylitis), history of lumbar surgery , fracture or lumbar tumor.
Who cannot join
- Pregnant or breastfeeding women
- Allergy to injected products (Depomedrol or Linisol)
- Psychiatric disorders hindering understanding of the protocol
- Local or systemic infection
- Coagulation disorder
- Obese with a BMI> 35 kg / m²
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Hôpital de Braine l'Alleud Waterloo
Braine-l'Alleud, 1420
CHU Saint-Pierre
Brussels, 1000
Hôpital Erasme
Brussels, 1070
About this study
In adults with chronic low back pain, the investigators will compare the effectiveness of the medial bundle branch block on three lumbar levels (L3-L4, L4-L5 and L5-S1) performed either by radiographic guidance or by ultrasound approach according to a transverse approach.
The objective of this study will be to evaluate the benefit of these both procedures on pain, on the practice of daily activities and the incidence of adverse events in order to show whether the two modalities are equivalent.
Read the detailed description
"Lumbar facet syndrome" is a source of spinal distress affecting up to 45% of patients with chronic low back pain due to inflammation, degenerative or arthritic changes, overloading of the posterior or posterior lumbar facet joints.
First-line treatment for the relief of chronic low back pain of zygapophyseal joint origin includes bed rest, oral pain relievers / anti-inflammatory drugs, and physiotherapy. If unsuccessful, intra-articular injections and medial bundle branch block (BBM) provide diagnosis and are an alternative to neurotomy (radiofrequency or cryoneurolysis).
The BBM targets the medial branches of the posterior twigs, that is, it blocks the nociceptors and the muscles of the dermatome undertaken by targeting the medial branches of the dorsal vertebral branch supplying a facet above and below the vertebrae which ensure sensory innervation of the facet joint. The current standard technique is radiography requiring three punctures (transverse-axial plane) and the ultrasound technique is also described in this plan and also requires three puncture points. The investigatorswould like to compare this promising new technique to the standard radiographic technique since it would avoid irradiation and is easier to handle.
For this study, the investigatorswill compare the BBM on three lumbar levels (L3-L4, L4-L5 and L5-S1) performed under radiography versus ultrasound according to a transverse approach.
To compare the equivalence of this two modalities the investigators will evaluate :
- the benefit of the procedure on pain (via the visual analogue scale (VAS) collected before then at 1 week and at 1 month after the infiltrations)
- the evolution of the possibility of carrying out daily activities (via the Duke's activity status index (DASI) scale, collected at the same intervals as the VAS)
- the limits of daily activities (via the Oswestry Disability Index (ODI), collected at the same time intervals)
- the incidence of adverse events
A screening for anxiety and depressive disorders will be also performed before infiltration by the Hospital Anxiety and depression scale (HADS) comprising 14 items.
- Conditions
- Chronic Low-back Pain, Lumbar Facet Joint Syndrome
- Being tested
- Ultrasound guided infiltration, Fluoroscopy guided infiltration
- Keywords
- Pain, Fluoroscopy, Ultrasound, Injection Site Infiltration, Chronic, Lumbar facet joint syndrome, Medial branch blocks, Disability, Local anesthetic, Lumbalgia, Lumbar zygapophysial joint, Facet syndrome, Chronic Low-back Pain, Medial branch block
- Medical subject headings
- Pain, Bronchiolitis Obliterans Syndrome, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided infiltrationOther
In the patient in prone position, an infiltration guided by ultrasound will be performed in three puncture points (L3-L4, L4-L5 and L5-S1 levels unilaterally). At each level, 1mL of a mixture consisting of 3mL of Linisol 2% (60mg of lidocaine) and 1mL of Depomedrol 40mg / Lidocaine 10mg is injected.
Fluoroscopy guided infiltrationOther
In the patient in prone position, an infiltration guided by fluoroscopy will be performed in three puncture points (L3-L4, L4-L5 and L5-S1 levels unilaterally). At each level, 1mL of a mixture consisting of 3mL of Linisol 2% (60mg of lidocaine) and 1mL of Depomedrol 40mg / Lidocaine 10mg is injected.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided infiltration | Experimental | The patient is positioned in the prone position with a block under his stomach. After disinfection of the lumbosacral region with alcoholic chlorhexidine 0.5%, the investigators position the convex probe of the ultrasound machine in the transverse plane. Once the spine has been located, the investigators look for the spinous processes of the lower lumbar vertebrae L4 and L5 with the mark on the cranial side and the side opposite the mark on the side of the sacrum. The latter is visualized as a continuous hyperechoic line. Then, the probe is tilted 90 ° to be in a transverse plane. A 22G needle is introduced in a transverse axis starting from the laterality by inserting it in the direction of the median bone contacts of the lower lumbar vertebrae L3, L4 and L5. An infiltration will be unilaterally performed at three levels (L3-L4, L4-L5 and L5-S1 levels). Receives: Other: Ultrasound guided infiltration |
| Fluoroscopy-guided infiltration | Experimental | The patient is positioned in the prone position with a block under his stomach. The lumbosacral region is disinfected with alcoholic chlorhexidine 0.5%.
The C-shaped arm of a X-ray fluoroscopy is positioned around the patient in an antero-posterior view tilted ¾ in order to free the classic view called "scotty dogs ". The puncture point is determined by the positioning of the needle in so-called "tunnel vision". The needle is thus brought to the bone contact corresponding to the eye of the scotty dog in tunnel vision, an area corresponding to the passage of the lumbar median branch. An infiltration will be unilaterally performed at three levels (L3-L4, L4-L5 and L5-S1 levels). Receives: Other: Fluoroscopy guided infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI) score
Change in Oswestry Disability Index (ODI) score from baseline to 1 month after infiltration.
Oswestry Disability Index (ODI) will be calculated before and 1 month after procedure. This index (range 0 to 100) is used by clinicians and researchers to quantify disability for low back pain, with higher score indicating greater disability.
Measured: 1 month
Secondary outcomes (7)
Oswestry Disability Index (ODI) score
Change in Oswestry Disability Index (ODI) score from baseline to 1 week after infiltration.
Oswestry Disability Index (ODI) will be calculated before and 1 week after procedure. This index (range 0 to 100) is used by clinicians and researchers to quantify disability for low back pain, with higher score indicating greater disability.
Measured: 1 week
Change in Visual Analog Scale (VAS) pain score from baseline to 1 week after infiltration
Pain will be evaluated by Visual Analog Scale (VAS) before and 1 week after infiltration. Visual Analog pain score (scale= 0 no pain; 10= worst pain imaginable)
Measured: 1 week
Change in Visual Analog Scale (VAS) pain score from baseline to 1 month after infiltration
Pain will be evaluated by Visual Analog Scale (VAS) before and 1 month after infiltration.
Visual Analog pain score (scale= 0 no pain; 10= worst pain imaginable)
Measured: 1 month
Change in Duke Activity Status Index (DASI) from baseline to 1 week after infiltration
The Duke Activity Status Index (DASI) (range 0 to 58.2) will be calculated before and 1 week after procedure. This index is an assessment tool used to evaluate the possibility of carrying out daily activities, with higher scores indicating a higher functional capacity.
Measured: 1 week
Change in Duke Activity Status Index (DASI) from baseline to 1 month after infiltration
The Duke Activity Status Index (DASI) (range 0 to 58.2) will be calculated before and 1 month after procedure. This index is an assessment tool used to evaluate the possibility of carrying out daily activities, with higher scores indicating a higher functional capacity.
Measured: 1 month
Incidence of Adverse event (Hematoma, infection, intrathecal injection, spinal anesthesia)
Measured: 1 month
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) (range 0 to 21) will be calculated before procedure. (0-7 normal; 8-10 Borderline abnormal; 11-21 Abnormal)
Measured: Before infiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start6 Jan 2021
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital de Braine-l'Alleud, Erasme University Hospital
- Responsible party
- Sponsor
- Investigators
- Turgay Tuna, MD,PhD, Study director, Erasme University HospitalMarie-Laure Nisolle, MD, Principal investigator, Centre Hospitalier Universitaire Saint PierrePanayota Kapessidou, MD,PhD, Study chair, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658953
- Sponsor's protocol ID
- CE/20-11-10
- Status last verified
- Mar 2022
- First submitted
- 2 Dec 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han SH, Park KD, Cho KR, Park Y. Ultrasound versus fluoroscopy-guided medial branch block for the treatment of lower lumbar facet joint pain: A retrospective comparative study. Medicine (Baltimore). 2017 Apr;96(16):e6655. doi: 10.1097/MD.0000000000006655.
PubMed 28422871Won HS, Yang M, Kim YD. Facet joint injections for management of low back pain: a clinically focused review. Anesth Pain Med (Seoul). 2020 Jan 31;15(1):8-18. doi: 10.17085/apm.2020.15.1.8.
PubMed 33329784Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Lumbar facet joint nerve blocks in managing chronic facet joint pain: one-year follow-up of a randomized, double-blind controlled trial: Clinical Trial NCT00355914. Pain Physician. 2008 Mar-Apr;11(2):121-32.
PubMed 18354721Karkucak M, Batmaz I, Kerimoglu S, Ayar A. Comparison of clinical outcomes of ultrasonography-guided and blind local injections in facet syndrome: A 6-week randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(3):431-436. doi: 10.3233/BMR-181447.
PubMed 31524141Hurdle MF. Ultrasound-Guided Spinal Procedures for Pain: A Review. Phys Med Rehabil Clin N Am. 2016 Aug;27(3):673-86. doi: 10.1016/j.pmr.2016.04.011.
PubMed 27468672Ha DH, Shim DM, Kim TK, Kim YM, Choi SS. Comparison of ultrasonography- and fluoroscopy-guided facet joint block in the lumbar spine. Asian Spine J. 2010 Jun;4(1):15-22. doi: 10.4184/asj.2010.4.1.15. Epub 2010 Apr 26.
PubMed 20622950Kastler A, Kogl N, Gruber H, Skalla E, Loizides A. Lumbar medial branch cryoneurolysis under ultrasound guidance: initial report of five cases. Med Ultrason. 2020 Sep 5;22(3):293-298. doi: 10.11152/mu-2529.
PubMed 32898203Ye L, Wen C, Liu H. Ultrasound-guided versus low dose computed tomography scanning guidance for lumbar facet joint injections: same accuracy and efficiency. BMC Anesthesiol. 2018 Nov 7;18(1):160. doi: 10.1186/s12871-018-0620-7.
PubMed 30404599Kaye AD, Motejunas MW, Bonneval LA, Ehrhardt KP, Latimer DR, Trescot A, Wilson KE, Ibrahim IN, Cornett EM, Urman RD, Candido KD. Ultrasound practice for chronic pain procedures: A comprehensive review. Best Pract Res Clin Anaesthesiol. 2019 Dec;33(4):465-486. doi: 10.1016/j.bpa.2019.07.001. Epub 2019 Jul 18.
PubMed 31791564Yun DH, Kim HS, Yoo SD, Kim DH, Chon JM, Choi SH, Hwang DG, Jung PK. Efficacy of ultrasonography-guided injections in patients with facet syndrome of the low lumbar spine. Ann Rehabil Med. 2012 Feb;36(1):66-71. doi: 10.5535/arm.2012.36.1.66. Epub 2012 Feb 29.
PubMed 22506237Boswell MV, Colson JD, Sehgal N, Dunbar EE, Epter R. A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician. 2007 Jan;10(1):229-53.
PubMed 17256032Greher M, Kirchmair L, Enna B, Kovacs P, Gustorff B, Kapral S, Moriggl B. Ultrasound-guided lumbar facet nerve block: accuracy of a new technique confirmed by computed tomography. Anesthesiology. 2004 Nov;101(5):1195-200. doi: 10.1097/00000542-200411000-00020.
PubMed 15505456
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ultrasound-guided Versus Radioguided Medial Lumbar Bundle Branch Block
- ClinicalTrials.gov ID
- NCT04658953
- Acronym / sponsor ID
- CE/20-11-10
- Conditions
- Chronic Low-back Pain, Lumbar Facet Joint Syndrome
- Keywords
- Pain, Fluoroscopy, Ultrasound, Injection Site Infiltration, Chronic, Lumbar facet joint syndrome, Medial branch blocks, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Collaborators
- Hôpital de Braine-l'Alleud, Erasme University Hospital
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 9 Dec 2020 (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.
In adults with chronic low back pain, the investigators will compare the effectiveness of the medial bundle branch block on three lumbar levels (L3-L4, L4-L5 and L5-S1) performed either by radiographic guidance or by ultrasound approach according to a transverse approach.
The objective of this study will be to evaluate the benefit of these both procedures on pain, on the practice of daily activities and the incidence of adverse events in order to show whether the two modalities are equivalent.
Detailed description
"Lumbar facet syndrome" is a source of spinal distress affecting up to 45% of patients with chronic low back pain due to inflammation, degenerative or arthritic changes, overloading of the posterior or posterior lumbar facet joints.
First-line treatment for the relief of chronic low back pain of zygapophyseal joint origin includes bed rest, oral pain relievers / anti-inflammatory drugs, and physiotherapy. If unsuccessful, intra-articular injections and medial bundle branch block (BBM) provide diagnosis and are an alternative to neurotomy (radiofrequency or cryoneurolysis).
The BBM targets the medial branches of the posterior twigs, that is, it blocks the nociceptors and the muscles of the dermatome undertaken by targeting the medial branches of the dorsal vertebral branch supplying a facet above and below the vertebrae which ensure sensory innervation of the facet joint. The current standard technique is radiography requiring three punctures (transverse-axial plane) and the ultrasound technique is also described in this plan and also requires three puncture points. The investigatorswould like to compare this promising new technique to the standard radiographic technique since it would avoid irradiation and is easier to handle.
For this study, the investigatorswill compare the BBM on three lumbar levels (L3-L4, L4-L5 and L5-S1) performed under radiography versus ultrasound according to a transverse approach.
To compare the equivalence of this two modalities the investigators will evaluate :
- the benefit of the procedure on pain (via the visual analogue scale (VAS) collected before then at 1 week and at 1 month after the infiltrations)
- the evolution of the possibility of carrying out daily activities (via the Duke's activity status index (DASI) scale, collected at the same intervals as the VAS)
- the limits of daily activities (via the Oswestry Disability Index (ODI), collected at the same time intervals)
- the incidence of adverse events
A screening for anxiety and depressive disorders will be also performed before infiltration by the Hospital Anxiety and depression scale (HADS) comprising 14 items.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided infiltration | Experimental | Other: Ultrasound guided infiltrationThe patient is positioned in the prone position with a block under his stomach. After disinfection of the lumbosacral region with alcoholic chlorhexidine 0.5%, the investigators position the convex probe of the ultrasound machine in the transverse plane. Once the spine has been located, the investigators look for the spinous processes of the lower lumbar vertebrae L4 and L5 with the mark on the cranial side and the side opposite the mark on the side of the sacrum. The latter is visualized as a continuous hyperechoic line. Then, the probe is tilted 90 ° to be in a transverse plane. A 22G needle is introduced in a transverse axis starting from the laterality by inserting it in the direction of the median bone contacts of the lower lumbar vertebrae L3, L4 and L5. An infiltration will be unilaterally performed at three levels (L3-L4, L4-L5 and L5-S1 levels). |
| Fluoroscopy-guided infiltration | Experimental | Other: Fluoroscopy guided infiltrationThe patient is positioned in the prone position with a block under his stomach. The lumbosacral region is disinfected with alcoholic chlorhexidine 0.5%. The C-shaped arm of a X-ray fluoroscopy is positioned around the patient in an antero-posterior view tilted ¾ in order to free the classic view called "scotty dogs ". The puncture point is determined by the positioning of the needle in so-called "tunnel vision". The needle is thus brought to the bone contact corresponding to the eye of the scotty dog in tunnel vision, an area corresponding to the passage of the lumbar median branch. An infiltration will be unilaterally performed at three levels (L3-L4, L4-L5 and L5-S1 levels). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic Low-back pain for at least 3 months, without response to a conservative treatment of minimum 4 weeks
- No signs of dissociated pain, radiculitis, neurological diseases (including stroke, Parkinson's disease), spinal instability or deformities (such as scoliosis, ankylosing spondylitis), history of lumbar surgery , fracture or lumbar tumor.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women
- Allergy to injected products (Depomedrol or Linisol)
- Psychiatric disorders hindering understanding of the protocol
- Local or systemic infection
- Coagulation disorder
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 infiltrationIn the patient in prone position, an infiltration guided by ultrasound will be performed in three puncture points (L3-L4, L4-L5 and L5-S1 levels unilaterally). At each level, 1mL of a mixture consisting of 3mL of Linisol 2% (60mg of lidocaine) and 1mL of Depomedrol 40mg / Lidocaine 10mg is injected. | Other | Ultrasound-guided infiltration |
| Fluoroscopy guided infiltrationIn the patient in prone position, an infiltration guided by fluoroscopy will be performed in three puncture points (L3-L4, L4-L5 and L5-S1 levels unilaterally). At each level, 1mL of a mixture consisting of 3mL of Linisol 2% (60mg of lidocaine) and 1mL of Depomedrol 40mg / Lidocaine 10mg is injected. | Other | Fluoroscopy-guided infiltration |
Primary outcome
Oswestry Disability Index (ODI) score
Time frame: 1 month
Change in Oswestry Disability Index (ODI) score from baseline to 1 month after infiltration. Oswestry Disability Index (ODI) will be calculated before and 1 month after procedure. This index (range 0 to 100) is used by clinicians and researchers to quantify disability for low back pain, with higher score indicating greater disability.
7 secondary outcomes
Oswestry Disability Index (ODI) score
Time frame: 1 week
Change in Visual Analog Scale (VAS) pain score from baseline to 1 week after infiltration
Time frame: 1 week
Change in Visual Analog Scale (VAS) pain score from baseline to 1 month after infiltration
Time frame: 1 month
Change in Duke Activity Status Index (DASI) from baseline to 1 week after infiltration
Time frame: 1 week
Change in Duke Activity Status Index (DASI) from baseline to 1 month after infiltration
Time frame: 1 month
Incidence of Adverse event (Hematoma, infection, intrathecal injection, spinal anesthesia)
Time frame: 1 month
Hospital Anxiety and Depression Scale (HADS)
Time frame: Before infiltration
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 Mar 2022.
- Background: PubMed 28422871Han SH, Park KD, Cho KR, Park Y. Ultrasound versus fluoroscopy-guided medial branch block for the treatment of lower lumbar facet joint pain: A retrospective comparative study. Medicine (Baltimore). 2017 Apr;96(16):e6655. doi: 10.1097/MD.0000000000006655.
- Background: PubMed 33329784Won HS, Yang M, Kim YD. Facet joint injections for management of low back pain: a clinically focused review. Anesth Pain Med (Seoul). 2020 Jan 31;15(1):8-18. doi: 10.17085/apm.2020.15.1.8.
- Background: PubMed 18354721Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Lumbar facet joint nerve blocks in managing chronic facet joint pain: one-year follow-up of a randomized, double-blind controlled trial: Clinical Trial NCT00355914. Pain Physician. 2008 Mar-Apr;11(2):121-32.
- Background: PubMed 31524141Karkucak M, Batmaz I, Kerimoglu S, Ayar A. Comparison of clinical outcomes of ultrasonography-guided and blind local injections in facet syndrome: A 6-week randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(3):431-436. doi: 10.3233/BMR-181447.
- Background: PubMed 27468672Hurdle MF. Ultrasound-Guided Spinal Procedures for Pain: A Review. Phys Med Rehabil Clin N Am. 2016 Aug;27(3):673-86. doi: 10.1016/j.pmr.2016.04.011.
- Background: PubMed 20622950Ha DH, Shim DM, Kim TK, Kim YM, Choi SS. Comparison of ultrasonography- and fluoroscopy-guided facet joint block in the lumbar spine. Asian Spine J. 2010 Jun;4(1):15-22. doi: 10.4184/asj.2010.4.1.15. Epub 2010 Apr 26.
- Background: PubMed 32898203Kastler A, Kogl N, Gruber H, Skalla E, Loizides A. Lumbar medial branch cryoneurolysis under ultrasound guidance: initial report of five cases. Med Ultrason. 2020 Sep 5;22(3):293-298. doi: 10.11152/mu-2529.
- Background: PubMed 30404599Ye L, Wen C, Liu H. Ultrasound-guided versus low dose computed tomography scanning guidance for lumbar facet joint injections: same accuracy and efficiency. BMC Anesthesiol. 2018 Nov 7;18(1):160. doi: 10.1186/s12871-018-0620-7.
- Background: PubMed 31791564Kaye AD, Motejunas MW, Bonneval LA, Ehrhardt KP, Latimer DR, Trescot A, Wilson KE, Ibrahim IN, Cornett EM, Urman RD, Candido KD. Ultrasound practice for chronic pain procedures: A comprehensive review. Best Pract Res Clin Anaesthesiol. 2019 Dec;33(4):465-486. doi: 10.1016/j.bpa.2019.07.001. Epub 2019 Jul 18.
- Background: PubMed 22506237Yun DH, Kim HS, Yoo SD, Kim DH, Chon JM, Choi SH, Hwang DG, Jung PK. Efficacy of ultrasonography-guided injections in patients with facet syndrome of the low lumbar spine. Ann Rehabil Med. 2012 Feb;36(1):66-71. doi: 10.5535/arm.2012.36.1.66. Epub 2012 Feb 29.
- Background: PubMed 17256032Boswell MV, Colson JD, Sehgal N, Dunbar EE, Epter R. A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician. 2007 Jan;10(1):229-53.
- Background: PubMed 15505456Greher M, Kirchmair L, Enna B, Kovacs P, Gustorff B, Kapral S, Moriggl B. Ultrasound-guided lumbar facet nerve block: accuracy of a new technique confirmed by computed tomography. Anesthesiology. 2004 Nov;101(5):1195-200. doi: 10.1097/00000542-200411000-00020.
- 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.
Turgay Tuna, MD,PhD study director
Erasme University Hospital
Marie-Laure Nisolle, MD principal investigator
Centre Hospitalier Universitaire Saint Pierre
Panayota Kapessidou, MD,PhD study chair
Centre Hospitalier Universitaire Saint Pierre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided infiltration and Fluoroscopy guided infiltration in people with Chronic Low-back Pain and Lumbar Facet Joint Syndrome, run by Centre Hospitalier Universitaire Saint Pierre at 3 sites 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 2 inclusion and 6 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Oswestry Disability Index (ODI) score (time frame: 1 month). 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 NCT04658953, which also lists 12 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 22 Mar 2022.