Clinical trial NCT04212949: The Effect of Transcranial Magnetic Stimulation Therapy in Patients With Lumbar Radiculopathy
Official title: The Effect of Transcranial Magnetic Stimulation Therapy Combined With Transforaminal Epidural Steroid Injection in Patients With Lumbar Radiculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Radiculopathy
Keywords: lumbar radiculopathy
rTMS
TESI
treatment
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Low back and leg pain
timeFrame: before treatment (T0)
measure: Low back and leg pain
timeFrame: 1st hour after injection (T1)
measure: Low back and leg pain
timeFrame: 3rd week of treatment (T2)
measure: Low back and leg pain
timeFrame: 3rd month of treatment (T3)
measure: Low back and leg pain
timeFrame: 6th month of treatment (T4)
Secondary outcomes:
measure: Quality of life and activities of daily living
timeFrame: before treatment (T0)
measure: Quality of life and activities of daily living
timeFrame: 3rd week of treatment (T1)
measure: Quality of life and activities of daily living
timeFrame: 3rd month of treatment (T2)
measure: Quality of life and activities of daily living
timeFrame: 6th month of treatment (T3)
measure: Neuropathic pain
timeFrame: before treatment (T0)
measure: Neuropathic pain
timeFrame: 3rd week of treatment (T1)
measure: Neuropathic pain
timeFrame: 3rd month of treatment (T2)
measure: Neuropathic pain
timeFrame: 6th month of treatment (T3)
measure: Central sensitization
timeFrame: before treatment (T0)
measure: Central sensitization
timeFrame: 3rd week of treatment (T1)
measure: Central sensitization
timeFrame: 3rd month of treatment (T2)
measure: Central sensitization
timeFrame: 6th month of treatment (T3)
measure: The Beck depression inventory
timeFrame: before treatment (T0)
measure: The Beck depression inventory
timeFrame: 3rd week of treatment (T1)
measure: The Beck depression inventory
timeFrame: 3rd month of treatment (T2)
measure: The Beck depression inventory
timeFrame: 6th month of treatment (T3)
measure: Adverse events
timeFrame: before treatment (T0)
measure: Adverse events
timeFrame: 1st hour after injection (T1)
measure: Adverse events
timeFrame: 3rd week of treatment (T2)
measure: Adverse events
timeFrame: 3rd month of treatment (T3)
measure: Adverse events
timeFrame: 6th month of treatment (T4)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University
name: Hakan Gündüz, Prof
role: STUDY_CHAIR
affiliation: Marmara University
name: Gülseren Akyüz, Prof
role: STUDY_CHAIR
References:
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citation: Lefaucheur 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.
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