Evaluation of Erector Spina Plane Block(ESPB)'s Effectiveness on Patients With Lumbar Radiculopathy

Early Phase 1

Withdrawn

• Conditions: Radiculopathy; Radiculopathy Lumbar; Pain, Back
• Interventions: Procedure: Erector Spinae Plane Block; Drug: NSAID; Behavioral: Home Exercise Programme

• Registration Number: NCT05261581
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

A new regional anaesthetic block technique is described in this issue of Anaesthesia by Chin et al. whereby local anaesthetic is injected within a plane beneath the erector spinae muscle to achieve analgesia for abdominal surgery. After this the block has been used successfully for many implications such as post-herpetic neuralgia, thoracic and abdominal chronic or acute pain management, rib fractures, breast surgery, chronic cancer pain and etc. Cadaveric and radiologic data showed that contrast injected into the tissue plane deep to erector spinae muscle and superficial to the transverse processes and intertransverse connective tissues penetrates anteriorly to anesthetize the spinal nerves. And some cadeveric studies resulted with where both the dorsal and ventral rami of the thoracic spinal nerves were marked with dye after ESPB. Some studies even showed that dye reached to the epidural space. In this manner we we hypothesize that ESPB could be effective with radiculopathy pain.

Detailed Description

Forero et al. proposed in 2016 an interfascial block to provide analgesia to patients suffering from thoracic chronic pain consisting of an injection of local anesthetic inside the erector spinae plane (ESP). As stated by the authors in their original work, the discovery of this technique was casual, but subsequent observations showed that this "casual" technique had a wide range of possible indications not only to thoracic area but varying from chronic to acute traumatic pain, from thoracic to orthopedic surgery, from children to elderly patients.

There are three groups of muscles involved in this block: erector spinae muscles group, transverso-spinal muscles group and levatores rostrum. Erector spinae muscles are not a single muscle, but a really complex muscular group formed by ileocostalis muscles, longissimus muscles and spinalis muscles. These muscles link bone components of the back to each other: the spinous process to spinous process, rib to rib and transverse process to transverse process.Deep to this group of muscles, we find the transverso-spinal group of muscles connecting the transverse processes to the spinous processes (semispinalis, multifidus, rotatores), and deeper still are the levatores rostrum, originating from the transverse processes and inserting into the ribs. Together, all these muscles act as a geometrical structure that would facilitate the spread of local anesthetic.

The ESP block's therapeutic effect is attributed to the cranial-caudal spread of local anesthetic over multiple vertebral levels in the musculofascial plane deep to the erector spinae muscle, accompanied by diffusion anteriorly into the contiguous paravertebral and intercostal spaces, where the local anesthetic then acts on the ventral and dorsal rami of spinal nerves. The subsequent realization that the erector spinae muscle extends from the lumbar spine to cervical spine led to extrapolation of the ESP block for many different indications in different regions of the body.

Since after Forero's proposition in 2016 many researchers successfully tried ESPB primarily in post-operative pain and acute trauma pain management. More recently there have been some studies focusing on musculoskeletal originated pain such as myofascial pain syndrome, chronic shoulder pain/frozen shoulder etc. In this manner we hypothesize that ESPB could be effective for reducing pain effectively in a short treatment time. And considering other spinal interventions for radiculopathy pain such as transforaminal/epidural blocks require more skilled stuff, scopy device and a special place for it. Since ESPB can be done via ultrasonography and needs less stuff we also think that it can be a more cost efficient treatment choice for radiculopathy pain.

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-20
• Study Start: 2022-03-01
• Study First Posted: 2022-03-02
• Primary Completion: 2022-08-30
• Study Completion: 2022-11-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Aged between 18 and 75
• MRI proven radiculopathy
• Pain level on NRS should be at least 4 and above

Exclusion Criteria

• Congenital or acquired musculospinal deformities
• Pregnancy or lactation
• Systemic inflammatory or infectious diseases
• Patients with high risk of bleeding(usage of coumadin etc)
• Malignancy
• Neuromuscular diseases
• Unstable psychiatric condition
• Patient get any kind of intervention(transforaminal or epidural injections, radiofrequency treatment etc) to the pain source

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Home Exercise Programme	Patients that will get ESPB, NSAID and exercise programme
Intervention	Erector Spinae Plane Block	Patients that will get ESPB, NSAID and exercise programme
Control	Home Exercise Programme	Patients that will only get NSAID and exercise programme
Intervention	NSAID	Patients that will get ESPB, NSAID and exercise programme
Control	NSAID	Patients that will only get NSAID and exercise programme

Primary Outcome Measures

Name	Time	Method
Pain Assesment	Change from Baseline NPRS at 1st and 3rd months	The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).Numerical Rating Scales have shown high correlations with other pain-assessment tools in several studies. The feasibility of its use and good compliance have also been proven.
The Health Assessment Questionnaire (HAQ)	Change from Baseline HAQ at 1st and 3rd months	The HAQ was developed as a comprehensive measure of outcome in patients with a wide variety of rheumatic diseases. It has also been applied to patients with man diseases and in studies of normal aging. It should be considered a generic rather than a disease-specific instrument. Its focus is on self-reported patient-oriented outcome measures, rather than process measures.; The Aides and Devices are assigned to the specific 8 HAQ sections as follows: Dressing: Devices used for dressing (button hook, zipper pull, shoe horn, etc.) Arising: Special or built up chair Eating: Built up or special utensils Walking: Cane, Walker, Crutches, Wheelchair Hygiene: Bathtub bar, Long-handled appliances in bathroom, Raised toilet seat Reach: Long-handled appliances for reach Grip: Jar opener for jars previously opened Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section.
Oswestry Low Back Pain Disability Questionnaire	Change from Baseline ODI at 1st and 3rd months	The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.; Each topic category is followed by 6 statements describing different potential scenarios in the patient's life and the patient checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Roland-Morris Disability Questionnaire	Change from Baseline RMQ at 1st and 3rd months	RMQ is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. A patient taking the survey agrees or disagrees with these statements (Yes/No).; The final score, out of 24 represents the degree of disability due to low back pain. A maximum score of 24 indicates the greatest degree of disability from back pain. This score may be used to monitor the pain and symptoms of patients with back pain over time.

Secondary Outcome Measures

Name	Time	Method
Change in Lomber Range of Motion(ROM)	Change from Baseline Lomber ROM at 1st and 3rd months	The Lumbar Spine normal active range of motion is as follows: Flexion: 70-90\* Extension: 30\* Lateral Flexion: 30\* Rotation: 30\* Decreased in Range of motion in lumbar spine mostly caused by muscle/fascia adhesion and tightness limiting your mobility. Another more likely scenario is that fixation in vertebra or another cause of pain. The motion restriction and muscle tightness often exist together but can be separate as well.

Trial Locations

Locations (1)

Bezmialem Vakıf University; 🇹🇷 Istanbul, Turkey