Low Back PainNCT06438952
Efficacy and Duration of Pain Relief in Transforaminal and Lumbar Sympathetic Blocks
A study testing Transforaminal steroid injection combined with lumbar sympathetic blockade and Transforaminal steroid injection only in people with Low Back Pain and Lumbar Disc Herniation, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).
Trial summary
Low back pain is a symptom that is frequently seen in the general population and reduces the quality of life of patients. Conventional medical treatment for patients with low back pain includes oral medication, lifestyle modification, education, exercises, lumbar traction and manual manipulation, heat application, and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain, Lumbar Disc Herniation
- What is being tested?
- Transforaminal steroid injection combined with lumbar sympathetic blockade and Transforaminal steroid injection only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jun 2024to Dec 2024
- Phase
- Interventional
- 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
- ASA I-II-III
- Patients who underwent facet joint injection and transforaminal injection due to lumbar disc herniation
Who cannot join
- Patients with known allergies to the drugs to be used in treatment
- Infection near the puncture site
- Known coagulation disorders
- Patients with internal fixation or severe anatomical variation such as scoliosis and tumor
- History of sympathetic chemical or thermal neurolysis
- Alcohol and drug use
Show all 12Show fewer
- Disorder of consciousness
- Liver failure, renal failure, advanced cardiac failure
- Uncontrolled diabetes mellitus
- Morbid obesity (body mass index (BMI) > 35 kg m-2)
- Female patients during pregnancy and breastfeeding
- Not approving the informed consent form
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 1 recruiting
- Recruiting
Aylin Ceren Şanlı
Istanbul
Aylin C Sanli, Asist Dr, +0905496522412, aylincerensanli@hotmail.com
- Completed
Aylin Ceren
Istanbul
About this study
Low back pain is a symptom that is frequently seen in the general population and reduces the quality of life of patients. Conventional medical treatment for patients with low back pain includes oral medication, lifestyle modification, education, exercises, lumbar traction and manual manipulation, heat application, and other interventional procedures. Epidural injections, one of the interventional procedures, are one of the common treatment methods for low back pain, especially caused by disc prolapse. Steroids are commonly used to reduce inflammation in the epidural space. Epidural steroid injection can be given to the lumbar epidural space via transforaminal, interlaminar and caudal routes, and the effectiveness rate of each is different. These interventional methods used to treat low back pain can be applied in combination.
The main purpose of this study is to observe how adding lumbar sympathetic blockade will affect the patient's pain in the postoperative period in patients to whom we applied caudal epidural and transforaminal steroid injection.
Read the detailed description
Low back pain is a symptom that is frequently seen in the general population and reduces the quality of life of patients. Conventional medical treatment for patients with low back pain includes oral medication, lifestyle modification, education, exercises, lumbar traction and manual manipulation, heat application, and other interventional procedures [1, 2]. Epidural injections, one of the interventional procedures, are one of the common treatment methods for low back pain, especially caused by disc prolapse. Steroids are widely used to reduce inflammation in the epidural space [3, 4]. Epidural steroid injection can be administered to the lumbar epidural space via transforaminal, interlaminar and caudal routes, and each has different efficacy rates [5-7].
Sympathetically maintained pain, including lumbar sympathetic ganglion block (LSGB), complex regional pain syndrome (CRPS) types I and II, neuropathies (such as postherpetic neuralgia, stump or phantom limb pain), diabetic polyneuropathy, and ischemic pain from vascular insufficiency in the lower leg It is a widely applied procedure for diagnosing and managing diseases [8]. The autonomic nervous system consists of sympathetic and parasympathetic departments. As the name suggests, blood supply to the lower extremity increases after lumbar sympathetic block. This is useful in sympathetic system-mediated treatment of pain [9].
The most important reason for adding fentanyl and magnesium as adjvams is to improve the quality of analgesia and provide analgesia for a longer period of time. Both fentanyl and magnesium have the ability to modulate neurotransmitter release and affect neuronal excitability. Fentanyl demonstrates the role of the sympathetic nervous system in modulating pain by increasing the effectiveness of endogenous opioids in the sympathetic ganglia and central nervous system. Magnesium competes with calcium; It reduces the release of neurotransmitters such as acetylcholine.
Magnesium's ability to inhibit the release of acetylcholine contributes to its anticonvulsant properties. Additionally, blocking NMDA receptors contributes to its analgesic effects. Additionally, magnesium's ability to enhance the effects of local anesthetics has been studied. By increasing the firing threshold in nerves and causing hyperpolarization, magnesium enhances the effect of local anesthetics, thereby improving nerve blockade. This enhancement of nerve blockade is particularly evident when magnesium is added to agents such as bupivacaine [10, 11].
These interventional methods used to treat low back pain can be applied in combination. There is not enough research on this subject.
- Conditions
- Low Back Pain, Lumbar Disc Herniation
- Being tested
- Transforaminal steroid injection combined with lumbar sympathetic blockade, Transforaminal steroid injection only
- Keywords
- Transforaminal Steroid İnjection, Lumbar Sympathetic Blockade, Lumbar Disc Herniation, Neuropathic Pain Questionnaire, Numerical Rating Scale
- Medical subject headings
- Low Back Pain, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal steroid injection combined with lumbar sympathetic blockadeProcedure or surgery
Transforaminal steroid injection will be made with 2 mg dexamethason + 20 mg lidocaine + 5mg bupivacaine + 5 mcg fentanyl + 100mg magnesium under US-guidance Lumbar sympathetic blockade will be made with 5 ml 0.5% bupivacaine + 6 mg dexamethason + 10 ml NaCl
Transforaminal steroid injection onlyProcedure or surgery
Transforaminal steroid injection will be made with 2 mg dexamethason + 20 mg lidocaine + 5mg bupivacaine + 5 mcg fentanyl + 100mg magnesium under US-guidance
| Study group | Role | What they receive |
|---|---|---|
| Addition of lumbar sympathetic blockade to transforaminal steroid injection | Active comparator | The patient will receive both transforaminal steroid injection and lumbar sympathetic blockade. Receives: Procedure: Transforaminal steroid injection combined with lumbar sympathetic blockade |
| Transforaminal steroid injection only | Placebo comparator | The patient will only receive transforaminal steroid injection. Receives: Procedure: Transforaminal steroid injection only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity score
Postoperative pain assessed with numeric rating scale (NRS 0: no pain 10:pain as bad as can be )
Measured: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month
Secondary outcomes (3)
Oswestry Disability Index (ODI)
Measured: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month
Neuropathic pain questionnaire
Measured: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month
Patient satisfaction
The patient is asked to give a score between 1 and 10 in terms of satisfaction with the procedure (1 = I am not satisfied with the procedure, 10 = I am very satisfied with the procedure).
Measured: Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zübeyde Özdemir, Study chair, ethics committee chairman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438952
- Sponsor's protocol ID
- E.142568
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Duration of Pain Relief in Transforaminal and Lumbar Sympathetic Blocks
- ClinicalTrials.gov ID
- NCT06438952
- Acronym / sponsor ID
- E.142568
- Conditions
- Low Back Pain, Lumbar Disc Herniation
- Keywords
- Transforaminal Steroid İnjection, Lumbar Sympathetic Blockade, Lumbar Disc Herniation, Neuropathic Pain Questionnaire, Numerical Rating Scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Jun 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.
Low back pain is a symptom that is frequently seen in the general population and reduces the quality of life of patients. Conventional medical treatment for patients with low back pain includes oral medication, lifestyle modification, education, exercises, lumbar traction and manual manipulation, heat application, and other interventional procedures. Epidural injections, one of the interventional procedures, are one of the common treatment methods for low back pain, especially caused by disc prolapse. Steroids are commonly used to reduce inflammation in the epidural space. Epidural steroid injection can be given to the lumbar epidural space via transforaminal, interlaminar and caudal routes, and the effectiveness rate of each is different. These interventional methods used to treat low back pain can be applied in combination.
The main purpose of this study is to observe how adding lumbar sympathetic blockade will affect the patient's pain in the postoperative period in patients to whom we applied caudal epidural and transforaminal steroid injection.
Detailed description
Low back pain is a symptom that is frequently seen in the general population and reduces the quality of life of patients. Conventional medical treatment for patients with low back pain includes oral medication, lifestyle modification, education, exercises, lumbar traction and manual manipulation, heat application, and other interventional procedures [1, 2]. Epidural injections, one of the interventional procedures, are one of the common treatment methods for low back pain, especially caused by disc prolapse. Steroids are widely used to reduce inflammation in the epidural space [3, 4]. Epidural steroid injection can be administered to the lumbar epidural space via transforaminal, interlaminar and caudal routes, and each has different efficacy rates [5-7].
Sympathetically maintained pain, including lumbar sympathetic ganglion block (LSGB), complex regional pain syndrome (CRPS) types I and II, neuropathies (such as postherpetic neuralgia, stump or phantom limb pain), diabetic polyneuropathy, and ischemic pain from vascular insufficiency in the lower leg It is a widely applied procedure for diagnosing and managing diseases [8]. The autonomic nervous system consists of sympathetic and parasympathetic departments. As the name suggests, blood supply to the lower extremity increases after lumbar sympathetic block. This is useful in sympathetic system-mediated treatment of pain [9].
The most important reason for adding fentanyl and magnesium as adjvams is to improve the quality of analgesia and provide analgesia for a longer period of time. Both fentanyl and magnesium have the ability to modulate neurotransmitter release and affect neuronal excitability. Fentanyl demonstrates the role of the sympathetic nervous system in modulating pain by increasing the effectiveness of endogenous opioids in the sympathetic ganglia and central nervous system. Magnesium competes with calcium; It reduces the release of neurotransmitters such as acetylcholine.
Magnesium's ability to inhibit the release of acetylcholine contributes to its anticonvulsant properties. Additionally, blocking NMDA receptors contributes to its analgesic effects. Additionally, magnesium's ability to enhance the effects of local anesthetics has been studied. By increasing the firing threshold in nerves and causing hyperpolarization, magnesium enhances the effect of local anesthetics, thereby improving nerve blockade. This enhancement of nerve blockade is particularly evident when magnesium is added to agents such as bupivacaine [10, 11].
These interventional methods used to treat low back pain can be applied in combination. There is not enough research on this subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Addition of lumbar sympathetic blockade to transforaminal steroid injection | Active comparator | Procedure: Transforaminal steroid injection combined with lumbar sympathetic blockadeThe patient will receive both transforaminal steroid injection and lumbar sympathetic blockade. |
| Transforaminal steroid injection only | Placebo comparator | Procedure: Transforaminal steroid injection onlyThe patient will only receive transforaminal steroid injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II-III
- Patients who underwent facet joint injection and transforaminal injection due to lumbar disc herniation
Key exclusion criteria (12 listed)
- Patients with known allergies to the drugs to be used in treatment
- Infection near the puncture site
- Known coagulation disorders
- Patients with internal fixation or severe anatomical variation such as scoliosis and tumor
- History of sympathetic chemical or thermal neurolysis
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 |
|---|---|---|
| Transforaminal steroid injection combined with lumbar sympathetic blockadeTransforaminal steroid injection will be made with 2 mg dexamethason + 20 mg lidocaine + 5mg bupivacaine + 5 mcg fentanyl + 100mg magnesium under US-guidance Lumbar sympathetic blockade will be made with 5 ml 0.5% bupivacaine + 6 mg dexamethason + 10 ml NaCl | Procedure or surgery | Addition of lumbar sympathetic blockade to transforaminal steroid injection |
| Transforaminal steroid injection onlyTransforaminal steroid injection will be made with 2 mg dexamethason + 20 mg lidocaine + 5mg bupivacaine + 5 mcg fentanyl + 100mg magnesium under US-guidance | Procedure or surgery | Transforaminal steroid injection only |
Primary outcome
Pain intensity score
Time frame: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month
Postoperative pain assessed with numeric rating scale (NRS 0: no pain 10:pain as bad as can be )
3 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month
Neuropathic pain questionnaire
Time frame: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month
Patient satisfaction
Time frame: Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: Undecided. yes
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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.
Zübeyde Özdemir study chair
ethics committee chairman
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transforaminal steroid injection combined with lumbar sympathetic blockade and Transforaminal steroid injection only in people with Low Back Pain and Lumbar Disc Herniation, run by Bezmialem Vakif University at 2 sites 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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 3 Jun 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 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zübeyde Özdemir (+90 2125232288 ext. 3238, etikkurul@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity score (time frame: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month). 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 3 Jun 2024.