REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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EFFECTIVENESS OF REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN PATIENTS WITH FAILED BACK SURGERY SYNDROME A DOUBLE-BLINDED, RANDOMISED, PLACEBO CONTROLLED TRIAL

Conditions
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Failed Back Surgery Syndrome

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation
* Device: Sham Repetitive transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repetitive Transcranial Magnetic Stimulation Group<br>Patients in r-TMS group received r-TMS 20-min (1000 pulses) daily session, 5 days per weeks, for a total of 10 sessions. | Device: Repetitive Transcranial Magnetic Stimulation<br>* Patients in r-TMS group received 5 Hz of r-TMS. R-TMS applied with MagVenture device (MagPro X100, Denmark, 2009) and figure eight coil (MMC 140 parabolic, MagVenture).<br>|
| Sham Comparator: Sham Group<br>Control group received sham r-TMS with the same protocol. | Device: Sham Repetitive transcranial Magnetic Stimulation<br>* Control group received sham r-TMS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | All groups were evaluated for low back and leg pain with Visual Analogue Scale (VAS) for rest, activity, and sleep-disturbing. Patients were instructed to indicate the severity of pain on a 10- point scale, on which 0 meant no pain, 5 meant moderate pain, and 10 meant intolerable pain. | 4 months | 
| Oswestry Disability Index | Functional status in all groups was evaluated with the Oswestry disability index (ODI). The ODI consists of 10 topics concerning pain, lifting, ability of selfcare, ability to walk, sit, stand and travel, social life, and sleep quality and is intended to assess disability and quality of life related to low back pain. ODI scores range from 0 (no disability) to 100 (maximum disability possible). | 4 months | 
| DN-4 Interview Questionnaire | The DN4-interview questionnaire (0-10) was used to identify neuropathic pain. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pittsburgh Sleep Quality Index | To evaluate the subjective amount of sleep, we used The Pittsburgh Sleep Quality Index (PSQI). The PSQI evaluates the sleep quality of the previous month, and it is clinically useful in the evaluation of several sleep disorders that affect sleep quality. It includes 19 self-administered questions and 5 questions to be answered by bedroom companions. | 4 months | 
| Beck Depression Inventory | Symptoms of depression were evaluated by means of the Beck Depression Inventory. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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repetitive transcranial magnetic stimulation, back pain, failed back surgery syndrome