Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347328
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-29
Brief Title:
The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain a Randomised Study of the Benefits of Ultrasound-guided Infiltration Versus Unguided Infiltration Prospective Randomised Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InCHO
Brief Summary:
Lumbar facet joints have been implicated in chronic low back pain in over 45 of patients with isolated chronic common low back pain
Low back pain is the most common form of spinal pain more chronic and severe than cancer pain The annual prevalence of chronic low back pain ranges from 15 to 45 one-off prevalence 30 lifetime prevalence 54-80 Because of this extremely high incidence doctors from a wide range of specialities perform interventional techniques in a variety of settings
Facet joints have long been recognised as a source of back pain In 1911 Goldthwait first recognised their role as a potential source of back pain In 1933 Ghormley introduced the term facet syndrome defining lumbosacral pain with or without radicular pain Badgley later suggested that facet joints could be a primary source of pain independently of spinal nerve compression They demonstrated the role of posterior facet joints PFJs in a large number of patients with low back pain whose symptoms were not caused by a herniated disc The underlying physiological concept of the PJF was introduced by Hirsch et al in 1963 They demonstrated that injecting a hypertonic saline solution into the region of the facet joints caused pain
The management of chronic low back pain due to zygapophyseal involvement lumbar facet joints consists primarily of conservative treatment This is based on analgesics anti-inflammatory drugs physiotherapy and weight loss where appropriate Other non-surgical options may be proposed including glucocorticoid injections into the facet joints Glucocorticoid injections which act by reducing inflammation are commonly used in routine care to treat spinal pain This pain may be due to a variety of pathologies including discogenic or facet-related or mixed ligamentous or muscular linked to a regional or global disorder of spinal statics They are commonly used as a standard treatment for chronic spinal pain
Traditionally in routine clinical practice if there is significant paravertebral contracture and the clinical signs point to posterior joint involvement a glucocorticoid injection is given in the doctors surgery at the time of consultation using anatomical landmarks to guide needle placement However few studies have demonstrated the efficacy of anatomical marking for infiltration of posterior joints notably Cohen et al Suis systematic review of the use of this technique
With the advent of new imaging modalities such as ultrasound more and more practitioners are turning to image-guided injections To date only the fluoroscopy-guided technique is considered reliable for facet joint infiltration
In order to improve the clinical efficacy of the various interventional therapeutic solutions some authors have supported the use of ultrasound guidance Several studies have been published comparing ultrasound-guided infiltration and infiltration using anatomical location in the shoulder region the iliopsoas and in epicondilitis While ultrasound guidance in areas such as the iliopsoas or the shoulder seems useful it has not yet been proven that guidance is advantageous in spinal areas such as the facet joints
To our knowledge no randomised methodologically sound study has yet been carried out to compare the benefit of ultrasound-guided infiltration versus infiltration with anatomical location
The aim of our study is to show that ultrasound-guided zygoapophyseal infiltration is superior to anatomically-guided infiltration in terms of pain assessment
Low back pain is the most common form of spinal pain more chronic and severe than cancer pain The annual prevalence of chronic low back pain ranges from 15 to 45 one-off prevalence 30 lifetime prevalence 54-80 Because of this extremely high incidence doctors from a wide range of specialities perform interventional techniques in a variety of settings
Facet joints have long been recognised as a source of back pain In 1911 Goldthwait first recognised their role as a potential source of back pain In 1933 Ghormley introduced the term facet syndrome defining lumbosacral pain with or without radicular pain Badgley later suggested that facet joints could be a primary source of pain independently of spinal nerve compression They demonstrated the role of posterior facet joints PFJs in a large number of patients with low back pain whose symptoms were not caused by a herniated disc The underlying physiological concept of the PJF was introduced by Hirsch et al in 1963 They demonstrated that injecting a hypertonic saline solution into the region of the facet joints caused pain
The management of chronic low back pain due to zygapophyseal involvement lumbar facet joints consists primarily of conservative treatment This is based on analgesics anti-inflammatory drugs physiotherapy and weight loss where appropriate Other non-surgical options may be proposed including glucocorticoid injections into the facet joints Glucocorticoid injections which act by reducing inflammation are commonly used in routine care to treat spinal pain This pain may be due to a variety of pathologies including discogenic or facet-related or mixed ligamentous or muscular linked to a regional or global disorder of spinal statics They are commonly used as a standard treatment for chronic spinal pain
Traditionally in routine clinical practice if there is significant paravertebral contracture and the clinical signs point to posterior joint involvement a glucocorticoid injection is given in the doctors surgery at the time of consultation using anatomical landmarks to guide needle placement However few studies have demonstrated the efficacy of anatomical marking for infiltration of posterior joints notably Cohen et al Suis systematic review of the use of this technique
With the advent of new imaging modalities such as ultrasound more and more practitioners are turning to image-guided injections To date only the fluoroscopy-guided technique is considered reliable for facet joint infiltration
In order to improve the clinical efficacy of the various interventional therapeutic solutions some authors have supported the use of ultrasound guidance Several studies have been published comparing ultrasound-guided infiltration and infiltration using anatomical location in the shoulder region the iliopsoas and in epicondilitis While ultrasound guidance in areas such as the iliopsoas or the shoulder seems useful it has not yet been proven that guidance is advantageous in spinal areas such as the facet joints
To our knowledge no randomised methodologically sound study has yet been carried out to compare the benefit of ultrasound-guided infiltration versus infiltration with anatomical location
The aim of our study is to show that ultrasound-guided zygoapophyseal infiltration is superior to anatomically-guided infiltration in terms of pain assessment
Detailed Description:
This is a multicentre prospective interventional study involving two groups of patients randomised blinded category 2 at the Nice University Hospital the Antibes University Hospital and the Cannes University Hospital The control group will consist of patients receiving unguided infiltration The experimental group will consist of patients receiving ultrasound-guided infiltration
Inclusion and follow-up visits will be carried out at the following centres Nice University Hospital Antibes University Hospital and Cannes University Hospital The infiltration ultrasound-guided and non-ultrasound-guided will be carried out by the rheumatologist sonographer at the Nice University Hospital only The ultrasound will be performed by a trained rheumatologist using a low-frequency convex probe 1-8 MHz andor a linear probe 12-15 MhZ The investigators will perform B-mode tracking in two perpendicular planes to locate the target The probe will be positioned vertically about 3 to 4 cm to the left or right of the line of the spinous processes The sonographic appearance of the spinous processes is easy to identify as they form several bumps The injection will be carried out under strict aseptic conditions with the lumbar puncture needle 20G introduced in line with the probe at an angle of approximately 45 longitudinally to the axis of the posterior articular joints The needle will be advanced under local anaesthetic using approximately 5 cc of 5 Xylocaine until contact with the bone positioning and adapting the needle dynamically throughout the procedure The symptomatic joint will be injected with 1 ml of betamethasone The duration of the procedure from disinfection to removal of the needle will be recorded as will the immediate post-gestational complications and finally the VAS of the pain felt by the patient
Inclusion and follow-up visits will be carried out at the following centres Nice University Hospital Antibes University Hospital and Cannes University Hospital The infiltration ultrasound-guided and non-ultrasound-guided will be carried out by the rheumatologist sonographer at the Nice University Hospital only The ultrasound will be performed by a trained rheumatologist using a low-frequency convex probe 1-8 MHz andor a linear probe 12-15 MhZ The investigators will perform B-mode tracking in two perpendicular planes to locate the target The probe will be positioned vertically about 3 to 4 cm to the left or right of the line of the spinous processes The sonographic appearance of the spinous processes is easy to identify as they form several bumps The injection will be carried out under strict aseptic conditions with the lumbar puncture needle 20G introduced in line with the probe at an angle of approximately 45 longitudinally to the axis of the posterior articular joints The needle will be advanced under local anaesthetic using approximately 5 cc of 5 Xylocaine until contact with the bone positioning and adapting the needle dynamically throughout the procedure The symptomatic joint will be injected with 1 ml of betamethasone The duration of the procedure from disinfection to removal of the needle will be recorded as will the immediate post-gestational complications and finally the VAS of the pain felt by the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None