REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME

Fatih Sultan Mehmet Training and Research Hospital

Status: Completed

Conditions: Failed Back Surgery Syndrome

Treatments: Device: Sham Repetitive transcranial Magnetic Stimulation; Device: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04003714

meryemyılmazkaysın

Details and patient eligibility

About

Failed back surgery syndrome (FBSS) is the term of persistent back and/or leg pain after surgery for lumbar disk herniation (LDH). Repetitive transcranial magnetic stimulation (r-TMS) is a technique that allows non-invasive and relatively painless stimulation of cerebral cortex. It can reduce the experience of chronic pain by using magnetic field to produce small electrical currents in the cortex.The aim of this study is to determine the effectiveness of r-TMS treatment on patients with FBSS.

Full description

Methods: In this double-blinded, randomized, placebo-controlled trial, 20 patients (aged 34-65 years) clinically diagnosed as FBSS, who had a history of surgery for LDH with persistent back and leg pain. Patients in r-TMS group received 5 Hz of r-TMS, as a 20-min (1000 pulses) daily session, 5 days per weeks, for a total of 10 sessions. R-TMS applied with MagVenture device (MagPro X100, Denmark, 2009) and figure eight coil (MMC 140 parabolic, MagVenture). Control group received sham r-TMS with the same protocol. Patients were assessed at baseline,after 5th and 10th sessions and 1 and 3 months after treatment. Visual Analogue Scale (VAS), DN-4 (Douleur Neuropathique-4 Questionnaire), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI) were used for evaluation.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 34-65 years
• Clinically diagnosed as FBSS
• History of surgery for LDH with persistent back and leg pain
• Patients with no root compression in postoperative magnetic resonance imaging of lumbar spine

Exclusion criteria

• Epilepsy
• Stroke
• Head trauma
• History of intracranial operation
• Cardiac pacemaker
• Pregnancy
• Postoperative lumbar root compression
• Neurologic deficits
• Prior physiotherapy for low back pain last 6 month

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Repetitive Transcranial Magnetic Stimulation Group

Experimental group

Description:

Patients in r-TMS group received r-TMS 20-min (1000 pulses) daily session, 5 days per weeks, for a total of 10 sessions.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Sham Group

Sham Comparator group

Description:

Control group received sham r-TMS with the same protocol.

Treatment:

Device: Sham Repetitive transcranial Magnetic Stimulation