REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME
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|ClinicalTrials.gov Identifier: NCT04003714|
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Failed Back Surgery Syndrome||Device: Repetitive Transcranial Magnetic Stimulation Device: Sham Repetitive transcranial Magnetic Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- 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.
- 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).
- DN-4 Interview Questionnaire [ Time Frame: 4 months ]The DN4-interview questionnaire (0-10) was used to identify neuropathic pain.
- 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.
- Beck Depression Inventory [ Time Frame: 4 months ]Symptoms of depression were evaluated by means of the Beck Depression Inventory.
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
|Principal Investigator:||Meryem Yılmaz Kaysın, MD||Fatih Sultan Mehmet Training and Research Hospital|