- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05261581
Evaluation of Erector Spina Plane Block(ESPB)'s Effectiveness on Patients With Lumbar Radiculopathy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Ozan Volkan Yurdakul, Assoc. Prof.
- Phone Number: +905543715127
- Email: yurdakul_ozan@yahoo.com
Study Locations
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Istanbul, Turkey
- Recruiting
- Bezmialem Vakıf University
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Contact:
- Ozan Volkan Yurdakul, Assoc. Prof.
- Phone Number: +902124530453
- Email: yurdakul_ozan@yahoo.com
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Sub-Investigator:
- Mert Kara, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Patients that will get ESPB, NSAID and exercise programme
|
Erector spinae block (ESB) is an ultrasound-guided interfascial plane block.
The local anesthetic is injected using ultrasound guidance superficial to transverse process and deep to erector spinae muscle group
Non-steroidal anti-inflammatory drugs (NSAIDs) are medicines that are widely used to relieve pain, reduce inflammation.
Other Names:
Home exercise programme will include some stretches that aid in pain relief by helping take stress off the low back and hips, core stabilization exercises and postural exercises.
Other Names:
|
Active Comparator: Control
Patients that will only get NSAID and exercise programme
|
Non-steroidal anti-inflammatory drugs (NSAIDs) are medicines that are widely used to relieve pain, reduce inflammation.
Other Names:
Home exercise programme will include some stretches that aid in pain relief by helping take stress off the low back and hips, core stabilization exercises and postural exercises.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Assesment
Time Frame: 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.
|
Change from Baseline NPRS at 1st and 3rd months
|
The Health Assessment Questionnaire (HAQ)
Time Frame: 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. |
Change from Baseline HAQ at 1st and 3rd months
|
Oswestry Low Back Pain Disability Questionnaire
Time Frame: 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. |
Change from Baseline ODI at 1st and 3rd months
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Roland-Morris Disability Questionnaire
Time Frame: 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. |
Change from Baseline RMQ at 1st and 3rd months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Lomber Range of Motion(ROM)
Time Frame: 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. |
Change from Baseline Lomber ROM at 1st and 3rd months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Tulgar S, Selvi O, Senturk O, Serifsoy TE, Thomas DT. Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Cureus. 2019 Jan 2;11(1):e3815. doi: 10.7759/cureus.3815.
- Forero M, Rajarathinam M, Adhikary SD, Chin KJ. Erector spinae plane block for the management of chronic shoulder pain: a case report. Can J Anaesth. 2018 Mar;65(3):288-293. doi: 10.1007/s12630-017-1010-1. Epub 2017 Nov 13.
- De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.
- Sotome S, Sawada A, Wada A, Shima H, Kutomi G, Yamakage M. Erector spinae plane block versus retrolaminar block for postoperative analgesia after breast surgery: a randomized controlled trial. J Anesth. 2021 Feb;35(1):27-34. doi: 10.1007/s00540-020-02855-y. Epub 2020 Sep 11.
- Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.
- Tulgar S, Thomas DT, Suslu H. Ultrasound guided erector spinae plane block relieves lower cervical and interscapular myofascial pain, a new indication. J Clin Anesth. 2019 Mar;53:74. doi: 10.1016/j.jclinane.2018.10.008. Epub 2018 Oct 19. No abstract available.
- Takahashi H, Suzuki T. Erector spinae plane block for low back pain in failed back surgery syndrome: a case report. JA Clin Rep. 2018 Aug 27;4(1):60. doi: 10.1186/s40981-018-0198-6.
- Tulgar S, Balaban O. Spread of local anesthetic in erector spine plane block at thoracic and lumbar levels. Reg Anesth Pain Med. 2019 Jan;44(1):134-135. doi: 10.1136/rapm-2018-000027. No abstract available.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13.01.2022-E.46715-23/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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