The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain

NCT06347328 | Not Yet Recruiting

• 1 other identifier: 23-AOI-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Chronic Low-back Pain

Keywords

infiltration; low back pain; facet joint; betametasone; pain

Outcome Measures

Primary Outcomes (1)

• 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).

  at inclusion, and three months after procedure

Secondary Outcomes (3)

• measure function state by EIFEL questionnaire

  at inclusion and 3 months after procedure

• measure function state by ODI questionnaire

  at inclusion and 3 months after procedure

• pain evaluation by VAS scale

  at 30 minutes , one month and two months after the procedure

Study Arms (2)

non-echo-guided infiltration

ACTIVE COMPARATOR

Procedure: non-echo-guided infiltration

echo-guided infiltration

EXPERIMENTAL

Procedure: echo-guided infiltration

Interventions

echo-guided infiltration PROCEDURE

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

echo-guided infiltration

non-echo-guided infiltration PROCEDURE

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.

non-echo-guided infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Withdrawal of consent
• Instability of the spine
• Spondylodiscitis
• Fracture of any location

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CHU de NICE

Nice, CHU de Nice, 06000, France

Location

Ch Cannes

Cannes, France

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

STEPHANIE FERRERO, MD

CONTACT

+33492035477; ferrero.s@chu-nice.fr

CHRISTIAN ROUX, Pr

CONTACT

roux.c2@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 5, 2024

Record last verified: 2024-03

Locations

FR (2)