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REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME

Primary Purpose

Failed Back Surgery Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sham Repetitive transcranial Magnetic Stimulation
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring repetitive transcranial magnetic stimulation, back pain, failed back surgery syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Repetitive Transcranial Magnetic Stimulation Group

    Sham Group

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    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.
    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).
    DN-4 Interview Questionnaire
    The DN4-interview questionnaire (0-10) was used to identify neuropathic pain.

    Secondary Outcome Measures

    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.
    Beck Depression Inventory
    Symptoms of depression were evaluated by means of the Beck Depression Inventory.

    Full Information

    First Posted
    June 28, 2019
    Last Updated
    February 18, 2020
    Sponsor
    Fatih Sultan Mehmet Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04003714
    Brief Title
    REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME
    Official Title
    EFFECTIVENESS OF REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN PATIENTS WITH FAILED BACK SURGERY SYNDROME A DOUBLE-BLINDED, RANDOMISED, PLACEBO CONTROLLED TRIAL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2014 (Actual)
    Primary Completion Date
    August 1, 2014 (Actual)
    Study Completion Date
    August 1, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fatih Sultan Mehmet Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Failed Back Surgery Syndrome
    Keywords
    repetitive transcranial magnetic stimulation, back pain, failed back surgery syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Repetitive Transcranial Magnetic Stimulation Group
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Sham Group
    Arm Type
    Sham Comparator
    Arm Description
    Control group received sham r-TMS with the same protocol.
    Intervention Type
    Device
    Intervention Name(s)
    Repetitive Transcranial Magnetic Stimulation
    Intervention Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    Sham Repetitive transcranial Magnetic Stimulation
    Intervention Description
    Control group received sham r-TMS.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale
    Description
    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.
    Time Frame
    4 months
    Title
    Oswestry Disability Index
    Description
    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).
    Time Frame
    4 months
    Title
    DN-4 Interview Questionnaire
    Description
    The DN4-interview questionnaire (0-10) was used to identify neuropathic pain.
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    The Pittsburgh Sleep Quality Index
    Description
    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.
    Time Frame
    4 months
    Title
    Beck Depression Inventory
    Description
    Symptoms of depression were evaluated by means of the Beck Depression Inventory.
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Meryem Yılmaz Kaysın, MD
    Organizational Affiliation
    Fatih Sultan Mehmet Training and Research Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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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    REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME

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