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
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
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
NCT ID
NCT04003714
First Posted
June 28, 2019
Last Updated
February 18, 2020
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
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.
Learn more about this trial
REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME
We'll reach out to this number within 24 hrs