Lumbar RadiculopathyNCT04212949
The Effect of Transcranial Magnetic Stimulation Therapy in Patients With Lumbar Radiculopathy
A study testing Repetitive transcranial magnetic stimulation (rTMS) and Transforaminal epidural steroid injection in people with Lumbar Radiculopathy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The present study aims to investigate the efficacy of repetitive transcranial magnetic stimulation of the motor cortex combined with transforaminal epidural steroid injection in patients with chronic lumbar radiculopathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS) and Transforaminal epidural steroid injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Nov 2019to 8 Dec 2020
- 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
- Aged between 20-60 years
- Symptoms lasting longer than 3 months
- To be planned TESI due to root compression which is caused by lumbar disk herniation
- To agree to participate in the study
Who cannot join
- Lumbar spinal stenosis
- Presence of clinical findings incompatible with MRI
- Spinal disease (trauma / tumor)
- Spondylodiscitis or inflammatory spondylitis
- Presence of epilepsy
- Presence of implanted medical devices such as pacemakers, insulin pumps
Show all 18Show fewer
- Intracranial metallic implant
- Previous cranial surgery history
- Brain tumor
- Severe hearing and vision loss
- To be applied TESI for the last six months
- Presence of surgical history through lumbar region
- Scoliosis
- Spodilolistezis
- Pregnancy
- Osteoporotic lumbar fracture
- The presence of inflammatory diseases that affect spinal morphology, such as ankylosing spondylitis
- Patients with electrophysiologically determined polyneuropathy, amyotrophic lateral sclerosis, etc. neurological disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul
Savaş Şencan, Asst. Prof, 05370665713, savas-44@hotmail.com
About this study
Official title: The Effect of Transcranial Magnetic Stimulation Therapy Combined With Transforaminal Epidural Steroid Injection in Patients With Lumbar Radiculopathy
The present study aims to investigate the efficacy of repetitive transcranial magnetic stimulation of the motor cortex combined with transforaminal epidural steroid injection in patients with chronic lumbar radiculopathy.
Read the detailed description
Treatment methods of lumbar radiculopathy include short-term bed rest, medical treatments, physical therapy and rehabilitation techniques, psychotherapy, acupuncture, cryotherapy, epidural steroid injections, and surgical treatment. Epidural steroid injection is an effective treatment procedure in patients whose conservative treatment methods are not successful. Fluoroscopy guided transforaminal epidural steroid injection (TESI) is the most ideal procedure and it is considered as an effective treatment approach in radicular pain and concomitant neuropathic pain because of reaching the target area, which is the origin of pathology. Although radicular pain is usually caused by a peripheral lesion, central sensitization and maladaptive plasticity have been shown to play an important role in the development and chronicity of this pain. These data suggest that central pain processing should be altered or stopped, especially in the presence of refractory pain. Repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) are non-invasive brain stimulation techniques that are increasingly being used to treat refractory neuropathic pain. Although short-term efficacy of rTMS treatment in radicular pain management was shown in one study, long-term efficacy was not evaluated and the necessity of trials evaluating long-term efficacy was reported. In accordance with these findings, we aimed to investigate the long-term effect of rTMS treatment in patients with chronic lumbar radiculopathy who received TESI.
Patients diagnosed with chronic lumbar radiculopathy and planned to administer fluoroscopy-guided TESI will be included in the study. Patients will be randomized into two groups following TESI. Home-based exercise program will be given to both groups after injection. One week after the injection, only the first group will receive 10 sessions of rTMS treatment for 2 weeks in addition to the exercise program. rTMS treatment will be performed with the device used in our clinic for neurological rehabilitation and pain management.
Patients will be assessed by a blind researcher using the Visual Analogue Scale (VAS) for low back and leg pain, the Douleur Neuropathique 4 Questions (DN-4) for neuropathic pain, the Oswestry Disability Index for disability, the Beck Depression Scale for depression, and the Central Sensitization Inventory for central sensitization. All assessments will be performed by the same physician before injection, first hour (only VAS), third week, third month, and sixth month after the injection. All adverse events will be noted.
After data collection, analysis will be performed with the appropriate statistical method.
- Conditions
- Lumbar Radiculopathy
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS), Transforaminal epidural steroid injection
- Keywords
- lumbar radiculopathy, rTMS, TESI, treatment
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Device
Stimulation will be performed from the contralateral M1 cortex of the painful side. Each stimulation session will consist of 1500 pulses (30 trains of 5 seconds each, with an inter-train interval of 25 seconds) delivered at a frequency of 10 Hz. The stimulation intensity will be set at 80% of the resting motor threshold.
Transforaminal epidural steroid injectionDrug
An epidural steroid injection under guidance of fluoroscopy is used to reduce inflammation at a lumbar spinal nerve root(s).
The following drugs will be used for this procedure: 80mg/2ml triamcinolone acetonide (sinakort-A) and 1 mL 0.5% bupivacaine (marcaine)
| Study group | Role | What they receive |
|---|---|---|
| Repetitive transcranial magnetic stimulation following TESI | Experimental | Active repetitive transcranial magnetic stimulation will be performed to the patients with lumbar radiculopathy who receive transforaminal epidural steroid injection. Receives: Device: Repetitive transcranial magnetic stimulation (rTMS); Drug: Transforaminal epidural steroid injection |
| Transforaminal epidural steroid injection | Active comparator | Transforaminal epidural steroid injection will be applied to the patients with lumbar radiculopathy. Receives: Drug: Transforaminal epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back and leg pain
Low back and leg pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no pain) to "10 cm" (intolerable pain).
Measured: before treatment (T0)
Low back and leg pain
Low back and leg pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no pain) to "10 cm" (intolerable pain).
Measured: 1st hour after injection (T1)
Low back and leg pain
Low back and leg pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no pain) to "10 cm" (intolerable pain).
Measured: 3rd week of treatment (T2)
Low back and leg pain
Low back and leg pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no pain) to "10 cm" (intolerable pain).
Measured: 3rd month of treatment (T3)
Low back and leg pain
Low back and leg pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no pain) to "10 cm" (intolerable pain).
Measured: 6th month of treatment (T4)
Secondary outcomes (21)
Quality of life and activities of daily living
The potential changes in quality of life and activities of daily living will be measured by validated Oswestry Disability Index scores. It consists of 10 questions and the patient gets a minimum of "0" and a maximum of "5" points for each question. According to this, it is calculated how many percent of the patient's life activities are affected. Higher scores mean a worse outcome.
Measured: before treatment (T0)
Quality of life and activities of daily living
The potential changes in quality of life and activities of daily living will be measured by validated Oswestry Disability Index scores. It consists of 10 questions and the patient gets a minimum of "0" and a maximum of "5" points for each question. According to this, it is calculated how many percent of the patient's life activities are affected. Higher scores mean a worse outcome.
Measured: 3rd week of treatment (T1)
Quality of life and activities of daily living
The potential changes in quality of life and activities of daily living will be measured by validated Oswestry Disability Index scores. It consists of 10 questions and the patient gets a minimum of "0" and a maximum of "5" points for each question. According to this, it is calculated how many percent of the patient's life activities are affected. Higher scores mean a worse outcome.
Measured: 3rd month of treatment (T2)
Quality of life and activities of daily living
The potential changes in quality of life and activities of daily living will be measured by validated Oswestry Disability Index scores. It consists of 10 questions and the patient gets a minimum of "0" and a maximum of "5" points for each question. According to this, it is calculated how many percent of the patient's life activities are affected. Higher scores mean a worse outcome.
Measured: 6th month of treatment (T3)
Neuropathic pain
Douleur Neuropathique 4 questions will be used to determine the presence of neuropathic pain. It consists of ten questions, 7 questions are related with symptoms and the answer to the other 3 questions is determined by clinical examination. Scoring is between 0 and10 and a score of 4 and above is considered as neuropathic pain.
Measured: before treatment (T0)
Neuropathic pain
Douleur Neuropathique 4 questions will be used to determine the presence of neuropathic pain. It consists of ten questions, 7 questions are related with symptoms and the answer to the other 3 questions is determined by clinical examination. Scoring is between 0 and10 and a score of 4 and above is considered as neuropathic pain.
Measured: 3rd week of treatment (T1)
Neuropathic pain
Douleur Neuropathique 4 questions will be used to determine the presence of neuropathic pain. It consists of ten questions, 7 questions are related with symptoms and the answer to the other 3 questions is determined by clinical examination. Scoring is between 0 and10 and a score of 4 and above is considered as neuropathic pain.
Measured: 3rd month of treatment (T2)
Neuropathic pain
Douleur Neuropathique 4 questions will be used to determine the presence of neuropathic pain. It consists of ten questions, 7 questions are related with symptoms and the answer to the other 3 questions is determined by clinical examination. Scoring is between 0 and10 and a score of 4 and above is considered as neuropathic pain.
Measured: 6th month of treatment (T3)
Central sensitization
Central sensatization inventory will be used to identify the presence and severity of central sensitization. Central Sensatization Inventory consists of 25 questions. Each question is scored between 0 and 4 (0 = never, 4 = always). A score of 40 or above indicates the presence of central sensitization with 81% sensitivity and 75% specificity. Central sensitization severity was defined as 0-29 subclinical, 30-39 mild, 40-49 moderate, 50-59 severe, >59 very severe. Higher scores mean a worse outcome.
Measured: before treatment (T0)
Central sensitization
Central sensatization inventory will be used to identify the presence and severity of central sensitization. Central Sensatization Inventory consists of 25 questions. Each question is scored between 0 and 4 (0 = never, 4 = always). A score of 40 or above indicates the presence of central sensitization with 81% sensitivity and 75% specificity. Central sensitization severity was defined as 0-29 subclinical, 30-39 mild, 40-49 moderate, 50-59 severe, >59 very severe. Higher scores mean a worse outcome.
Measured: 3rd week of treatment (T1)
Central sensitization
Central sensatization inventory will be used to identify the presence and severity of central sensitization. Central Sensatization Inventory consists of 25 questions. Each question is scored between 0 and 4 (0 = never, 4 = always). A score of 40 or above indicates the presence of central sensitization with 81% sensitivity and 75% specificity. Central sensitization severity was defined as 0-29 subclinical, 30-39 mild, 40-49 moderate, 50-59 severe, >59 very severe. Higher scores mean a worse outcome.
Measured: 3rd month of treatment (T2)
Central sensitization
Central sensatization inventory will be used to identify the presence and severity of central sensitization. Central Sensatization Inventory consists of 25 questions. Each question is scored between 0 and 4 (0 = never, 4 = always). A score of 40 or above indicates the presence of central sensitization with 81% sensitivity and 75% specificity. Central sensitization severity was defined as 0-29 subclinical, 30-39 mild, 40-49 moderate, 50-59 severe, >59 very severe. Higher scores mean a worse outcome.
Measured: 6th month of treatment (T3)
The Beck depression inventory
The Beck depression inventory is a 21-item, self-rated scale that evaluates key symptoms of depression including mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, crying, irritability, social withdrawal, indecisiveness, body image change, work difficulty, insomnia, fatigability, loss of appetite, weight loss, somatic preoccupation, and loss of libido. The minimum score is 0 and the maximum score is 63. Higher scores mean a worse outcome. Higher scores indicate the severity of depression.
Measured: before treatment (T0)
The Beck depression inventory
The Beck depression inventory is a 21-item, self-rated scale that evaluates key symptoms of depression including mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, crying, irritability, social withdrawal, indecisiveness, body image change, work difficulty, insomnia, fatigability, loss of appetite, weight loss, somatic preoccupation, and loss of libido. The minimum score is 0 and the maximum score is 63. Higher scores mean a worse outcome. Higher scores indicate the severity of depression.
Measured: 3rd week of treatment (T1)
The Beck depression inventory
The Beck depression inventory is a 21-item, self-rated scale that evaluates key symptoms of depression including mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, crying, irritability, social withdrawal, indecisiveness, body image change, work difficulty, insomnia, fatigability, loss of appetite, weight loss, somatic preoccupation, and loss of libido. The minimum score is 0 and the maximum score is 63. Higher scores mean a worse outcome. Higher scores indicate the severity of depression.
Measured: 3rd month of treatment (T2)
The Beck depression inventory
The Beck depression inventory is a 21-item, self-rated scale that evaluates key symptoms of depression including mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, crying, irritability, social withdrawal, indecisiveness, body image change, work difficulty, insomnia, fatigability, loss of appetite, weight loss, somatic preoccupation, and loss of libido. The minimum score is 0 and the maximum score is 63. Higher scores mean a worse outcome. Higher scores indicate the severity of depression.
Measured: 6th month of treatment (T3)
Adverse events
All adverse events and complications will be noted.
Measured: before treatment (T0)
Adverse events
All adverse events and complications will be noted.
Measured: 1st hour after injection (T1)
Adverse events
All adverse events and complications will be noted.
Measured: 3rd week of treatment (T2)
Adverse events
All adverse events and complications will be noted.
Measured: 3rd month of treatment (T3)
Adverse events
All adverse events and complications will be noted.
Measured: 6th month of treatment (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start8 Nov 2019
- Primary completion8 Nov 2020 (estimated)
- Study completion8 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Marmara 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hakan Gündüz, Prof, Study chair, Marmara UniversityGülseren Akyüz, Prof, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212949
- Sponsor's protocol ID
- 09.2019.983
- Status last verified
- Dec 2019
- First submitted
- 23 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang SS, Hwang BM, Son HJ, Cheong IY, Lee SJ, Lee SH, Chung TY. The dosages of corticosteroid in transforaminal epidural steroid injections for lumbar radicular pain due to a herniated disc. Pain Physician. 2011 Jul-Aug;14(4):361-70.
PubMed 21785479Attal N, Ayache SS, Ciampi De Andrade D, Mhalla A, Baudic S, Jazat F, Ahdab R, Neves DO, Sorel M, Lefaucheur JP, Bouhassira D. Repetitive transcranial magnetic stimulation and transcranial direct-current stimulation in neuropathic pain due to radiculopathy: a randomized sham-controlled comparative study. Pain. 2016 Jun;157(6):1224-1231. doi: 10.1097/j.pain.0000000000000510.
PubMed 26845524Roussel NA, Nijs J, Meeus M, Mylius V, Fayt C, Oostendorp R. Central sensitization and altered central pain processing in chronic low back pain: fact or myth? Clin J Pain. 2013 Jul;29(7):625-38. doi: 10.1097/AJP.0b013e31826f9a71.
PubMed 23739534Galhardoni R, Correia GS, Araujo H, Yeng LT, Fernandes DT, Kaziyama HH, Marcolin MA, Bouhassira D, Teixeira MJ, de Andrade DC. Repetitive transcranial magnetic stimulation in chronic pain: a review of the literature. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S156-72. doi: 10.1016/j.apmr.2014.11.010. Epub 2014 Nov 28.
PubMed 25437106Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.
PubMed 25034472Sari S, Aydin ON, Guleser G, Kurt I, Turan A. Effect of transforaminal anterior epidural steroid injection on neuropathic pain, quality of sleep and life. Agri. 2015;27(2):83-8. doi: 10.5505/agri.2015.91489.
PubMed 25944134
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Magnetic Stimulation Therapy Combined With Transforaminal Epidural Steroid Injection in Patients With Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT04212949
- Acronym / sponsor ID
- 09.2019.983
- Conditions
- Lumbar Radiculopathy
- Keywords
- lumbar radiculopathy, rTMS, TESI, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 8 Nov 2020 (estimated)
- Study completion
- 8 Dec 2020 (estimated)
- First posted
- 30 Dec 2019 (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.
The present study aims to investigate the efficacy of repetitive transcranial magnetic stimulation of the motor cortex combined with transforaminal epidural steroid injection in patients with chronic lumbar radiculopathy.
Detailed description
Treatment methods of lumbar radiculopathy include short-term bed rest, medical treatments, physical therapy and rehabilitation techniques, psychotherapy, acupuncture, cryotherapy, epidural steroid injections, and surgical treatment. Epidural steroid injection is an effective treatment procedure in patients whose conservative treatment methods are not successful. Fluoroscopy guided transforaminal epidural steroid injection (TESI) is the most ideal procedure and it is considered as an effective treatment approach in radicular pain and concomitant neuropathic pain because of reaching the target area, which is the origin of pathology. Although radicular pain is usually caused by a peripheral lesion, central sensitization and maladaptive plasticity have been shown to play an important role in the development and chronicity of this pain. These data suggest that central pain processing should be altered or stopped, especially in the presence of refractory pain. Repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) are non-invasive brain stimulation techniques that are increasingly being used to treat refractory neuropathic pain. Although short-term efficacy of rTMS treatment in radicular pain management was shown in one study, long-term efficacy was not evaluated and the necessity of trials evaluating long-term efficacy was reported. In accordance with these findings, we aimed to investigate the long-term effect of rTMS treatment in patients with chronic lumbar radiculopathy who received TESI.
Patients diagnosed with chronic lumbar radiculopathy and planned to administer fluoroscopy-guided TESI will be included in the study. Patients will be randomized into two groups following TESI. Home-based exercise program will be given to both groups after injection. One week after the injection, only the first group will receive 10 sessions of rTMS treatment for 2 weeks in addition to the exercise program. rTMS treatment will be performed with the device used in our clinic for neurological rehabilitation and pain management.
Patients will be assessed by a blind researcher using the Visual Analogue Scale (VAS) for low back and leg pain, the Douleur Neuropathique 4 Questions (DN-4) for neuropathic pain, the Oswestry Disability Index for disability, the Beck Depression Scale for depression, and the Central Sensitization Inventory for central sensitization. All assessments will be performed by the same physician before injection, first hour (only VAS), third week, third month, and sixth month after the injection. All adverse events will be noted.
After data collection, analysis will be performed with the appropriate statistical method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive transcranial magnetic stimulation following TESI | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS), Drug: Transforaminal epidural steroid injectionActive repetitive transcranial magnetic stimulation will be performed to the patients with lumbar radiculopathy who receive transforaminal epidural steroid injection. |
| Transforaminal epidural steroid injection | Active comparator | Drug: Transforaminal epidural steroid injectionTransforaminal epidural steroid injection will be applied to the patients with lumbar radiculopathy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 20-60 years
- Symptoms lasting longer than 3 months
- To be planned TESI due to root compression which is caused by lumbar disk herniation
- To agree to participate in the study
Key exclusion criteria (18 listed)
- Lumbar spinal stenosis
- Presence of clinical findings incompatible with MRI
- Spinal disease (trauma / tumor)
- Spondylodiscitis or inflammatory spondylitis
- Presence of epilepsy
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS)Stimulation will be performed from the contralateral M1 cortex of the painful side. Each stimulation session will consist of 1500 pulses (30 trains of 5 seconds each, with an inter-train interval of 25 seconds) delivered at a frequency of 10 Hz. The stimulation intensity will be set at 80% of the resting motor threshold. | Device | Repetitive transcranial magnetic stimulation following TESI |
| Transforaminal epidural steroid injectionAn epidural steroid injection under guidance of fluoroscopy is used to reduce inflammation at a lumbar spinal nerve root(s). The following drugs will be used for this procedure: 80mg/2ml triamcinolone acetonide (sinakort-A) and 1 mL 0.5% bupivacaine (marcaine) | Drug | Repetitive transcranial magnetic stimulation following TESI, Transforaminal epidural steroid injection |
Primary outcome
Low back and leg pain
Time frame: before treatment (T0)
Low back and leg pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no pain) to "10 cm" (intolerable pain).
Low back and leg pain
Time frame: 1st hour after injection (T1)
Low back and leg pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no pain) to "10 cm" (intolerable pain).
Low back and leg pain
Time frame: 3rd week of treatment (T2)
Low back and leg pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no pain) to "10 cm" (intolerable pain).
Low back and leg pain
Time frame: 3rd month of treatment (T3)
Low back and leg pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no pain) to "10 cm" (intolerable pain).
Low back and leg pain
Time frame: 6th month of treatment (T4)
Low back and leg pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no pain) to "10 cm" (intolerable pain).
21 secondary outcomes
Quality of life and activities of daily living
Time frame: before treatment (T0)
Quality of life and activities of daily living
Time frame: 3rd week of treatment (T1)
Quality of life and activities of daily living
Time frame: 3rd month of treatment (T2)
Quality of life and activities of daily living
Time frame: 6th month of treatment (T3)
Neuropathic pain
Time frame: before treatment (T0)
Neuropathic pain
Time frame: 3rd week of treatment (T1)
Neuropathic pain
Time frame: 3rd month of treatment (T2)
Neuropathic pain
Time frame: 6th month of treatment (T3)
Central sensitization
Time frame: before treatment (T0)
Central sensitization
Time frame: 3rd week of treatment (T1)
Central sensitization
Time frame: 3rd month of treatment (T2)
Central sensitization
Time frame: 6th month of treatment (T3)
The Beck depression inventory
Time frame: before treatment (T0)
The Beck depression inventory
Time frame: 3rd week of treatment (T1)
The Beck depression inventory
Time frame: 3rd month of treatment (T2)
The Beck depression inventory
Time frame: 6th month of treatment (T3)
Adverse events
Time frame: before treatment (T0)
Adverse events
Time frame: 1st hour after injection (T1)
Adverse events
Time frame: 3rd week of treatment (T2)
Adverse events
Time frame: 3rd month of treatment (T3)
Adverse events
Time frame: 6th month of treatment (T4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Background: PubMed 21785479Kang SS, Hwang BM, Son HJ, Cheong IY, Lee SJ, Lee SH, Chung TY. The dosages of corticosteroid in transforaminal epidural steroid injections for lumbar radicular pain due to a herniated disc. Pain Physician. 2011 Jul-Aug;14(4):361-70.
- Background: PubMed 26845524Attal N, Ayache SS, Ciampi De Andrade D, Mhalla A, Baudic S, Jazat F, Ahdab R, Neves DO, Sorel M, Lefaucheur JP, Bouhassira D. Repetitive transcranial magnetic stimulation and transcranial direct-current stimulation in neuropathic pain due to radiculopathy: a randomized sham-controlled comparative study. Pain. 2016 Jun;157(6):1224-1231. doi: 10.1097/j.pain.0000000000000510.
- Background: PubMed 23739534Roussel NA, Nijs J, Meeus M, Mylius V, Fayt C, Oostendorp R. Central sensitization and altered central pain processing in chronic low back pain: fact or myth? Clin J Pain. 2013 Jul;29(7):625-38. doi: 10.1097/AJP.0b013e31826f9a71.
- Background: PubMed 25437106Galhardoni R, Correia GS, Araujo H, Yeng LT, Fernandes DT, Kaziyama HH, Marcolin MA, Bouhassira D, Teixeira MJ, de Andrade DC. Repetitive transcranial magnetic stimulation in chronic pain: a review of the literature. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S156-72. doi: 10.1016/j.apmr.2014.11.010. Epub 2014 Nov 28.
- Background: PubMed 25034472Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.
- Background: PubMed 25944134Sari S, Aydin ON, Guleser G, Kurt I, Turan A. Effect of transforaminal anterior epidural steroid injection on neuropathic pain, quality of sleep and life. Agri. 2015;27(2):83-8. doi: 10.5505/agri.2015.91489.
- 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.
Hakan Gündüz, Prof study chair
Marmara University
Gülseren Akyüz, Prof study chair
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation (rTMS) and Transforaminal epidural steroid injection in people with Lumbar Radiculopathy, run by Marmara 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 4 inclusion and 18 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 30 Dec 2019. 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.
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 Savaş Şencan, Asst. Prof (05370665713, savas-44@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back and leg pain (time frame: before treatment (T0)). The study lists 5 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 NCT04212949, which also lists 6 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 30 Dec 2019.