RadiculopathyEarly Phase 1NCT05261581
Evaluation of Erector Spina Plane Block(ESPB)'s Effectiveness on Patients With Lumbar Radiculopathy
A Early Phase 1 study testing Erector Spinae Plane Block, NSAID and Home Exercise Programme in people with Radiculopathy and Radiculopathy Lumbar, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiculopathy, Radiculopathy Lumbar, Pain, Back
- What is being tested?
- Erector Spinae Plane Block, NSAID and Home Exercise Programme
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Nov 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75
- MRI proven radiculopathy
- Pain level on NRS should be at least 4 and above
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Radiculopathy, Radiculopathy Lumbar, Pain, Back
- Being tested
- Erector Spinae Plane Block, NSAID, Home Exercise Programme
- Medical subject headings
- Radiculopathy, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
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
NSAIDDrug
Also called Anti-inflammatory/Analgesic Treatment
Non-steroidal anti-inflammatory drugs (NSAIDs) are medicines that are widely used to relieve pain, reduce inflammation.
Home Exercise ProgrammeBehavioural
Also called Exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients that will get ESPB, NSAID and exercise programme Receives: Procedure: Erector Spinae Plane Block; Drug: NSAID; Behavioral: Home Exercise Programme |
| Control | Active comparator | Patients that will only get NSAID and exercise programme Receives: Drug: NSAID; Behavioral: Home Exercise Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assesment
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.
Measured: Change from Baseline NPRS at 1st and 3rd months
The Health Assessment Questionnaire (HAQ)
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.
Measured: Change from Baseline HAQ at 1st and 3rd months
Oswestry Low Back Pain Disability Questionnaire
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.
Measured: Change from Baseline ODI at 1st and 3rd months
Roland-Morris Disability Questionnaire
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.
Measured: Change from Baseline RMQ at 1st and 3rd months
Secondary outcomes (1)
Change in Lomber Range of Motion(ROM)
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.
Measured: Change from Baseline Lomber ROM at 1st and 3rd months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Mar 2022 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Why it stopped: Difficulties about the method of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261581
- Sponsor's protocol ID
- 13.01.2022-E.46715-23/1
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27501016Forero 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.
PubMed 29134518Sotome 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.
PubMed 32915300Ivanusic 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.
PubMed 29746445Tulgar 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.
PubMed 30868029Tulgar 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.
PubMed 30343227De 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.
PubMed 30621377Takahashi 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.
PubMed 32026979Tulgar 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.
PubMed 30640667
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Erector Spina Plane Block(ESPB)'s Effectiveness on Patients With Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT05261581
- Acronym / sponsor ID
- 13.01.2022-E.46715-23/1
- Conditions
- Radiculopathy, Radiculopathy Lumbar, Pain, Back
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties about the method of the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 2 Mar 2022 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Erector Spinae Plane Block, Drug: NSAID, Behavioral: Home Exercise ProgrammePatients that will get ESPB, NSAID and exercise programme |
| Control | Active comparator | Drug: NSAID, Behavioral: Home Exercise ProgrammePatients that will only get NSAID and exercise programme |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 75
- MRI proven radiculopathy
- Pain level on NRS should be at least 4 and above
Key exclusion criteria (8 listed)
- Congenital or acquired musculospinal deformities
- Pregnancy or lactation
- Systemic inflammatory or infectious diseases
- Patients with high risk of bleeding(usage of coumadin etc)
- Malignancy
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 |
|---|---|---|
| Erector Spinae Plane BlockErector 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 | Procedure or surgery | Intervention |
| NSAIDAlso: Anti-inflammatory/Analgesic TreatmentNon-steroidal anti-inflammatory drugs (NSAIDs) are medicines that are widely used to relieve pain, reduce inflammation. | Drug | Control, Intervention |
| Home Exercise ProgrammeAlso: ExerciseHome 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. | Behavioural | Control, Intervention |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Change in Lomber Range of Motion(ROM)
Time frame: Change from Baseline Lomber ROM at 1st and 3rd months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Background: PubMed 27501016Forero 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.
- Background: PubMed 29134518Forero 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.
- Background: PubMed 32915300Sotome 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.
- Background: PubMed 29746445Ivanusic 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.
- Background: PubMed 30868029Tulgar 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.
- Background: PubMed 30343227Tulgar 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.
- Background: PubMed 30621377De 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.
- Background: PubMed 32026979Takahashi 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.
- Background: PubMed 30640667Tulgar 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Erector Spinae Plane Block, NSAID and Home Exercise Programme in people with Radiculopathy and Radiculopathy Lumbar, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assesment (time frame: Change from Baseline NPRS at 1st and 3rd months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05261581, which also lists 9 linked publications.
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 7 Feb 2025.