REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME

February 18, 2020 updated by: Fatih Sultan Mehmet Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repetitive Transcranial Magnetic Stimulation Group
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
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).
Sham Comparator: Sham Group
Control group received sham r-TMS with the same protocol.
Device: Sham Repetitive transcranial Magnetic Stimulation
Control group received sham r-TMS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 4 months
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
Time Frame: 4 months
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
Time Frame: 4 months
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
Time Frame: 4 months
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
Time Frame: 4 months
Symptoms of depression were evaluated by means of the Beck Depression Inventory.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Investigators

  • Principal Investigator: Meryem Yılmaz Kaysın, MD, Fatih Sultan Mehmet Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 28, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (Actual)

July 1, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • meryemyılmazkaysın

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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 was 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. Lumbar isometric exercises were given to all patients in both groups. Outcome measures were visual analogue scale (VAS) for rest, activity, and sleep-disturbing; Oswestry disability index; DN4-interview questionnaire; Pittsburgh Sleep Quality Index; Beck Depression Inventory (BDI).

All patients were assessed at baseline, 5th session, 10th session, 1st and 3rd months after session.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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