Chronic Low-back PainInCHONCT06347328
The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain
A study testing echo-guided infiltration and non-echo-guided infiltration in people with Chronic Low-back Pain, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- echo-guided infiltration and non-echo-guided infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years
- Isolated intermittent or continuous chronic low back pain resulting in functional disability;
- Having undergone a CT scan or MRI of the lumbar spine, with the joint spaces of the lumbar facet visible, showing condensation or hypersignal of the posterior joints.
- Somatic or non-radicular low back pain lasting at least three months;
- Failure of conservative treatments, including physical therapy with exercises, chiropractic and pharmacological therapy;
- Initial or recurrent lumbago lasting more than 3 months.
- VAS pain greater than or equal to 4 on a scale of 0 to 10.
Who cannot join
- Withdrawal of consent
- Instability of the spine
- Spondylodiscitis
- Fracture of any location
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
CHRISTIAN ROUX, Pr contact
France2 sites
Ch Cannes
Cannes
JOHANNA AZYLAY, MD, J.AZULAY@ch-cannes.fr
CHU de NICE
Nice, CHU de Nice, 06000
STEPHANIE FERRERO, MD, +33492035477, ferrero.s@chu-nice.fr
CHRISTIAN ROUX, Pr, roux.c2@chu-nice.fr
About this study
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
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.
Read more
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 doctor's 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. Sui's 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.
Read the 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) and/or 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- echo-guided infiltration, non-echo-guided infiltration
- Keywords
- infiltration, low back pain, facet joint, betametasone, pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echo-guided infiltrationProcedure or surgery
the subjects will receive their injection in the ultrasound room. a glucocorticoid injection is given at the time of consultation, using anatomical ultrasound scan to guide needle placement
non-echo-guided infiltrationProcedure or surgery
the subjects will receive their injection in the ultrasound room.
a glucocorticoid injection is given at the time of consultation, using anatomical landmarks to guide needle placement.
The investigator simulate an ultrasound scan with a film shown on the screen.
| Study group | Role | What they receive |
|---|---|---|
| non-echo-guided infiltration | Active comparator | Not described Receives: Procedure: non-echo-guided infiltration |
| echo-guided infiltration | Experimental | Not described Receives: Procedure: echo-guided infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain progression
The difference in pain progression between baseline and 3 months will be assessed using a visual analogue scale (0-100). The VAS is graduated from 0 to 100 mm, with 0 = no pain and 100 = maximum pain perceived in the 48 hours preceding the consultation, as recommended by the OARSI in osteoarthritis on pain assessment. The pain VAS will be assessed at rest, at night and during activities. This will be documented at the start of the study, and three months later, using the VAS and the remission rate (VAS < 4).
Measured: at inclusion, and three months after procedure
Secondary outcomes (3)
measure function state by EIFEL questionnaire
In french "Echelle d'Incapacité Fonctionnelle pour l'Evaluation des Lombalgies" (EIFEL) questionnaire is a Functional Disability Scale for the Assessment of Low Back Pain.
The questionnaire is composed of 24 sentences to describe the patient's physical condition. The maximal value is 24, means a very disabling functional disability. Higher scores mean a worse outcome.
The difference in the evolution of the EIFEL questionnaire between baseline and 3 months compared between the two groups will be measured.
The EIFEL index is a french translation of the Rolland Morris questionnaire and has been validated for acute low back pain. It explores disability by combining handicap, impairment and incapacity.
Measured: at inclusion and 3 months after procedure
measure function state by ODI questionnaire
Evaluation of the difference in patients' functional status using the Oswestry Disability Index (ODI) between baseline and 3 months, compared between the two groups.
The Oswestry Low Back Pain Disability Questionnaire is used to measure the extent of pain-induced functional limitations in people with low back pain. The questionnaire provides the user with details of the general day-to-day functioning of the low back pain patient. Six response options are available for the following items: pain intensity, personal care (washing, dressing), lifting objects, moving around, sitting or standing, sleeping, sex life, social life, and travel/transportation. The first response option (score 0) denotes the absence of pain-related restrictions, while the sixth response option (score 5) denotes the greatest perceived restriction of an activity caused by pain.
Measured: at inclusion and 3 months after procedure
pain evaluation by VAS scale
The VAS is graduated from 0 to 100 mm, with 0 = no pain and 100 = maximum pain perceived.The pain VAS will be assessed at rest, at night and during activities. This will be documented at t 30 minutes after the procedure, one month, two months later, using the VAS and the remission rate (VAS < 4).
Measured: at 30 minutes , one month and two months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study startSep 2024 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347328
- Sponsor's protocol ID
- 23-AOI-01
- Acronym
- InCHO
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06347328
- Acronym / sponsor ID
- InCHO / 23-AOI-01
- Conditions
- Chronic Low-back Pain
- Keywords
- infiltration, low back pain, facet joint, betametasone, pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Apr 2024 (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.
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 doctor's 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. Sui's 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) and/or 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-echo-guided infiltration | Active comparator | Procedure: non-echo-guided infiltration |
| echo-guided infiltration | Experimental | Procedure: echo-guided infiltration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 80 years
- Isolated intermittent or continuous chronic low back pain resulting in functional disability;
- Having undergone a CT scan or MRI of the lumbar spine, with the joint spaces of the lumbar facet visible, showing condensation or hypersignal of the posterior joints.
- Somatic or non-radicular low back pain lasting at least three months;
- Failure of conservative treatments, including physical therapy with exercises, chiropractic and pharmacological therapy;
Key exclusion criteria (4 listed)
- Withdrawal of consent
- Instability of the spine
- Spondylodiscitis
- Fracture of any location
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 |
|---|---|---|
| echo-guided infiltrationthe subjects will receive their injection in the ultrasound room. a glucocorticoid injection is given at the time of consultation, using anatomical ultrasound scan to guide needle placement | Procedure or surgery | echo-guided infiltration |
| non-echo-guided infiltrationthe subjects will receive their injection in the ultrasound room. a glucocorticoid injection is given at the time of consultation, using anatomical landmarks to guide needle placement. The investigator simulate an ultrasound scan with a film shown on the screen. | Procedure or surgery | non-echo-guided infiltration |
Primary outcome
Change of pain progression
Time frame: at inclusion, and three months after procedure
The difference in pain progression between baseline and 3 months will be assessed using a visual analogue scale (0-100). The VAS is graduated from 0 to 100 mm, with 0 = no pain and 100 = maximum pain perceived in the 48 hours preceding the consultation, as recommended by the OARSI in osteoarthritis on pain assessment. The pain VAS will be assessed at rest, at night and during activities. This will be documented at the start of the study, and three months later, using the VAS and the remission rate (VAS < 4).
3 secondary outcomes
measure function state by EIFEL questionnaire
Time frame: at inclusion and 3 months after procedure
measure function state by ODI questionnaire
Time frame: at inclusion and 3 months after procedure
pain evaluation by VAS scale
Time frame: at 30 minutes , one month and two months after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
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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.
CHRISTIAN ROUX, Pr contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing echo-guided infiltration and non-echo-guided infiltration in people with Chronic Low-back Pain, run by Centre Hospitalier Universitaire de Nice at 2 sites 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact STEPHANIE FERRERO, MD (+33492035477, ferrero.s@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain progression (time frame: at inclusion, and three months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2024.