The Effect of Transcranial Magnetic Stimulation Therapy in Patients With Lumbar Radiculopathy

Lumbar Radiculopathy Clinical Trial

Official title:

The Effect of Transcranial Magnetic Stimulation Therapy Combined With Transforaminal Epidural Steroid Injection in Patients With Lumbar Radiculopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212949
• Other study ID #: 09.2019.983
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2019
• Est. completion date: December 8, 2020

Study information

• Verified date: December 2019
• Source: Marmara University
• Contact: Savas Sencan, Asst. Prof
• Phone: 05370665713
• Email: savas-44[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 8, 2020
• Est. primary completion date: November 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged between 20-60 years

2. Symptoms lasting longer than 3 months

3. To be planned TESI due to root compression which is caused by lumbar disk herniation

4. To agree to participate in the study

Exclusion Criteria:

1. Lumbar spinal stenosis

2. Presence of clinical findings incompatible with MRI

3. Spinal disease (trauma / tumor)

4. Spondylodiscitis or inflammatory spondylitis

5. Presence of epilepsy

6. Presence of implanted medical devices such as pacemakers, insulin pumps

7. Intracranial metallic implant

8. Previous cranial surgery history

9. Brain tumor

10. Severe hearing and vision loss

11. To be applied TESI for the last six months

12. Presence of surgical history through lumbar region

13. Scoliosis

14. Spodilolistezis

15. Pregnancy

16. Osteoporotic lumbar fracture

17. The presence of inflammatory diseases that affect spinal morphology, such as ankylosing spondylitis

18. Patients with electrophysiologically determined polyneuropathy, amyotrophic lateral sclerosis, etc. neurological disease

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

Device:
• 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.

Drug:
• Transforaminal epidural steroid injection
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)

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Attal 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):1224-31. doi: 10.1097/j.pain.0000000000000510. — View Citation

Galhardoni 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. Review. — View Citation

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. — View Citation

Lefaucheur JP, André-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, Jääskeläinen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schönfeldt-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. Review. — View Citation

Roussel 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. Review. — View Citation

Sari S, Aydin ON, Güleser 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	before treatment (T0)
Primary	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).	1st hour after injection (T1)
Primary	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).	3rd week of treatment (T2)
Primary	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).	3rd month of treatment (T3)
Primary	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).	6th month of treatment (T4)
Secondary	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.	before treatment (T0)
Secondary	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.	3rd week of treatment (T1)
Secondary	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.	3rd month of treatment (T2)
Secondary	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.	6th month of treatment (T3)
Secondary	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.	before treatment (T0)
Secondary	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.	3rd week of treatment (T1)
Secondary	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.	3rd month of treatment (T2)
Secondary	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.	6th month of treatment (T3)
Secondary	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.	before treatment (T0)
Secondary	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.	3rd week of treatment (T1)
Secondary	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.	3rd month of treatment (T2)
Secondary	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.	6th month of treatment (T3)
Secondary	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.	before treatment (T0)
Secondary	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.	3rd week of treatment (T1)
Secondary	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.	3rd month of treatment (T2)
Secondary	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.	6th month of treatment (T3)
Secondary	Adverse events	All adverse events and complications will be noted.	before treatment (T0)
Secondary	Adverse events	All adverse events and complications will be noted.	1st hour after injection (T1)
Secondary	Adverse events	All adverse events and complications will be noted.	3rd week of treatment (T2)
Secondary	Adverse events	All adverse events and complications will be noted.	3rd month of treatment (T3)
Secondary	Adverse events	All adverse events and complications will be noted.	6th month of treatment (T4)