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

Marmara University

Status: Unknown

Conditions: Lumbar Radiculopathy

Treatments: Drug: Transforaminal epidural steroid injection; Device: Repetitive transcranial magnetic stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04212949

09.2019.983

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Repetitive transcranial magnetic stimulation following TESI

Experimental group

Description:

Active repetitive transcranial magnetic stimulation will be performed to the patients with lumbar radiculopathy who receive transforaminal epidural steroid injection.

Treatment:

Drug: Transforaminal epidural steroid injection

Device: Repetitive transcranial magnetic stimulation (rTMS)

Transforaminal epidural steroid injection

Active Comparator group

Description:

Transforaminal epidural steroid injection will be applied to the patients with lumbar radiculopathy.

Treatment:

Drug: Transforaminal epidural steroid injection