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REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003714
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Fatih Sultan Mehmet Training and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Device: Repetitive Transcranial Magnetic Stimulation Device: Sham Repetitive transcranial Magnetic Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EFFECTIVENESS OF REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN PATIENTS WITH FAILED BACK SURGERY SYNDROME A DOUBLE-BLINDED, RANDOMISED, PLACEBO CONTROLLED TRIAL
Actual Study Start Date : May 1, 2014
Actual Primary Completion Date : August 1, 2014
Actual Study Completion Date : August 1, 2014

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.




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. DN-4 Interview Questionnaire [ Time Frame: 4 months ]
    The DN4-interview questionnaire (0-10) was used to identify neuropathic pain.


Secondary Outcome Measures :
  1. 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.

  2. Beck Depression Inventory [ Time Frame: 4 months ]
    Symptoms of depression were evaluated by means of the Beck Depression Inventory.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003714


Sponsors and Collaborators
Fatih Sultan Mehmet Training and Research Hospital
Investigators
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Principal Investigator: Meryem Yılmaz Kaysın, MD Fatih Sultan Mehmet Training and Research Hospital
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Responsible Party: Fatih Sultan Mehmet Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04003714    
Other Study ID Numbers: meryemyılmazkaysın
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatih Sultan Mehmet Training and Research Hospital:
repetitive transcranial magnetic stimulation
back pain
failed back surgery syndrome
Additional relevant MeSH terms:
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Syndrome
Failed Back Surgery Syndrome
Disease
Pathologic Processes
Postoperative Complications
Back Pain
Pain
Neurologic Manifestations