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

NCT04212949 | Unknown

• 1 other identifier: 09.2019.983
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Radiculopathy

Keywords

lumbar radiculopathy; rTMS; TESI; treatment

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (21)

• Quality of life and activities of daily living

  before treatment (T0)

• Quality of life and activities of daily living

  3rd week of treatment (T1)

• Quality of life and activities of daily living

  3rd month of treatment (T2)

• Quality of life and activities of daily living

  6th month of treatment (T3)

• Neuropathic pain

  before treatment (T0)

Study Arms (2)

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.

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.

Drug: Transforaminal epidural steroid injection

Interventions

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.

Repetitive transcranial magnetic stimulation following TESI

Transforaminal epidural steroid injection 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)

Repetitive transcranial magnetic stimulation following TESI; Transforaminal epidural steroid injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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.

  PMID: 21785479 BACKGROUND

• 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.

  PMID: 26845524 BACKGROUND

• 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.

  PMID: 23739534 BACKGROUND

• 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.

  PMID: 25437106 BACKGROUND

• 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.

  PMID: 25034472 BACKGROUND

• 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.

  PMID: 25944134 BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Hakan Gündüz, Prof

  Marmara University

  STUDY CHAIR

• Gülseren Akyüz, Prof

  Marmara University

  STUDY CHAIR

Central Study Contacts

Savaş Şencan, Asst. Prof

CONTACT

05370665713; savas-44@hotmail.com

Canan Şanal Toprak, Asst. Prof

CONTACT

05331381032; canansanal@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 30, 2019
• Study Start: November 8, 2019
• Primary Completion: November 8, 2020
• Study Completion: December 8, 2020
• Last Updated: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)