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

NCT ID: NCT04212949

Last Updated: 2019-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-08

Study Completion Date

2020-12-08

Brief Summary

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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

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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

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Lumbar Radiculopathy

Keywords

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lumbar radiculopathy rTMS TESI treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Repetitive transcranial magnetic stimulation following TESI

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

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Type 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 injection

Intervention Type DRUG

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)

Transforaminal epidural steroid injection

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

Group Type ACTIVE_COMPARATOR

Transforaminal epidural steroid injection

Intervention Type DRUG

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)

Interventions

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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.

Intervention Type DEVICE

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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hakan Gündüz, Prof

Role: STUDY_CHAIR

Marmara University

Gülseren Akyüz, Prof

Role: STUDY_CHAIR

Marmara University

Locations

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Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Savaş Şencan, Asst. Prof

Role: CONTACT

Phone: 05370665713

Email: [email protected]

Canan Şanal Toprak, Asst. Prof

Role: CONTACT

Phone: 05331381032

Email: [email protected]

Facility Contacts

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Savaş Şencan, Asst. Prof

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21785479 (View on PubMed)

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):1224-1231. doi: 10.1097/j.pain.0000000000000510.

Reference Type BACKGROUND
PMID: 26845524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23739534 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25437106 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25034472 (View on PubMed)

Sari 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.

Reference Type BACKGROUND
PMID: 25944134 (View on PubMed)

Other Identifiers

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09.2019.983

Identifier Type: -

Identifier Source: org_study_id