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This study aims to evaluate the effectiveness of 10 Hz neuronavigated repetitive transcranial magnetic stimulation (rTMS) to the left dorsolateral prefrontal cortex (DLPFC) on pain, stiffness, fatigue, depression/anxiety, quality of life and cognitive functions in fibromyalgia syndrome (FMS).
This is a single-center, prospective, randomized, double-blind, sham-controlled study in two-arm parallel-group design. Twenty participants will be randomized into 2 groups. Randomization will be performed using computer-generated block randomization with 1:1 allocation between the active rTMS group (Group 1) and the sham-control group (Group 2). Group 1 will receive high frequency repetitive transcranial magnetic stimulation (10hz-HF-rTMS)-A total 14 sessions of HF-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks). Group 2 will receive sham stimulation-A total 14 sessions of sham-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks).All patients will be evaluated with pain severity (VAS-10mm),stiffness severity (VAS-10mm), Fibromyalgia Impact Questionnaire (FIQ), Fatigue Severity Scale (FSS), Hospital Depression Anxiety Scale (HADS), Addenbrook Cognitive Examination-revised version (ACE-R).Patients will be questioned for the safety of treatment. Available drug therapies will be continued in both groups. Patients and clinical raters will be blinded to treatment. All patients will be reviewed by the investigator in terms of rTMS treatment safety and motor threshold determination before each treatment session and observed for possible side effects after treatment. All side effects will be recorded. Magnetic stimulation will be applied using Neurosoft-Neuro MS/D with a figure-of-eight-shaped coil. rTMS therapy will be applied under the guide of neuronavigation with the following parameters: target-left DLPFC, with the %90 of the RMT, 10 Hz stimulation for 5 seconds intervals (on) with 25 seconds inter-train intervals (off), 15 minutes, 1500 pulses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Active Comparator | Group 1 will receive high frequency repetitive transcranial magnetic stimulation (10hz-HF-rTMS) A total 14 sessions of HF-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks). |
|
| Sham rTMS | Sham Comparator | Group 2 will receive sham stimulation. A total 14 sessions of sham-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS + Neuronavigation | Device | Repetitive Transcranial Magnetic Stimulation (Neuro-MS/D) + Neural Navigator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale-Pain | The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome. | in the second week |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale-Pain | The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome. | in the sixth week |
| Fibromyalgia Impact Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale-Stiffness | The severity of the stiffness at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no stiffness, 10=severe stiffness) Higher scores mean a worse outcome. | in the second week |
| Fibromyalgia Impact Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayhan Aşkın, Assoc. Prof. | Izmir Katip Çelebi University Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir Katip Çelebi University Faculty of Medicine, Department of Physical Medicine and Rehabilitation | Izmir | 35290 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25797650 | Background | Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10. | |
| 25919472 |
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Twenty-eight patients were evaluated for participation in the study. Eight patients were excluded.
Participants were recruited from Physical Medicine and Rehabilitation (PMR) outpatient clinics of a university hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active rTMS | Group 1 will receive high frequency repetitive transcranial magnetic stimulation (10hz-HF-rTMS) A total 14 sessions of HF-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks). |
| FG001 | Sham rTMS | Group 2 will receive sham stimulation. A total 14 sessions of sham-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active rTMS | Group 1 will receive high frequency repetitive transcranial magnetic stimulation (10hz-HF-rTMS) A total 14 sessions of HF-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks). |
| BG001 | Sham rTMS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale-Pain | The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | in the second week |
|
6 weeks (Between the start of the study and the day when the last outcome measure is evaluated)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active rTMS | Group 1 will receive HF rTMS treatment daily from Monday to Friday in first 2 weeks. After first 2 weeks there will be sessions once a week for 1 month. There will be 14 sessions in total. rTMS + Neuronavigation: Repetitive Transcranial Magnetic Stimulation (Neuro-MS/D) + Neural Navigator |
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Current study has several limitations: First is the relatively small sample size. Second, we didn't use sham stimulation probe. Third, our patients only consisted of female gender.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doç.Dr. Ayhan AŞKIN | Izmir Katip Çelebi University, Faculty of Medicine | 00902322444444 | 1529 | ayhanaskin@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2019 | May 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D038361 | Neuronavigation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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Functional health status and quality of life of the participants were assessed with the Fibromyalgia impact questionnaire, which measures 10 different features (physical functioning, missed days of work, depression, anxiety, feeling good, morning tiredness, pain, stiffness, fatigue, and well-being over the past week). The total Fibromyalgia impact questionnaire score is maximum 80 points. Higher scores indicate lower functionality level.
| in the sixth week |
Functional health status and quality of life of the participants were assessed with the Fibromyalgia impact questionnaire, which measures 10 different features (physical functioning, missed days of work, depression, anxiety, feeling good, morning tiredness, pain, stiffness, fatigue, and well-being over the past week). The total Fibromyalgia impact questionnaire score is maximum 80 points. Higher scores indicate lower functionality level. |
| in the second week |
| Fatigue Severity Scale | Severity of fatigue was evaluated with Fatigue severity scale, a 9-item self-report questionnaire scale. Each item of this scale consists of statements that are scored on a seven-point Likert type scale ranging from 1 to 7. Total Fatigue severity scale score is calculated as the mean value of nine items. Higher scores indicate higher fatigue severity. (Total score range: 1-7) | in the sixth week |
| Hospital Anxiety and Depression Scale | Hospital anxiety and depression scale is an assessment tool developed to identify the risk of anxiety and depression and measure its level and change of severity. Its subscales are anxiety and depression. It contains 14 questions in total, including 7 (odd numbers) measuring anxiety and 7 (even numbers) measuring depression. The lowest and highest total score that a person can obtain from this scale are 0 and 42, respectively. High scores are associated with a worse psychiatric condition. | in the sixth week |
| Addenbrook Cognitive Examination Revised | Addenbrook Cognitive Examination-Revised is a brief cognitive test that consists of 5 basic sections: attention and orientation, memory, verbal fluency, language and visual-spatial abilities. Total score that can be obtained is 0-100. Higher scores are associated with a better cognitive state. | in the sixth week |
| Background |
| Klein MM, Treister R, Raij T, Pascual-Leone A, Park L, Nurmikko T, Lenz F, Lefaucheur JP, Lang M, Hallett M, Fox M, Cudkowicz M, Costello A, Carr DB, Ayache SS, Oaklander AL. Transcranial magnetic stimulation of the brain: guidelines for pain treatment research. Pain. 2015 Sep;156(9):1601-1614. doi: 10.1097/j.pain.0000000000000210. |
| 25581213 | Background | Knijnik LM, Dussan-Sarria JA, Rozisky JR, Torres IL, Brunoni AR, Fregni F, Caumo W. Repetitive Transcranial Magnetic Stimulation for Fibromyalgia: Systematic Review and Meta-Analysis. Pain Pract. 2016 Mar;16(3):294-304. doi: 10.1111/papr.12276. Epub 2015 Jan 12. |
| 27150193 | Background | Hou WH, Wang TY, Kang JH. The effects of add-on non-invasive brain stimulation in fibromyalgia: a meta-analysis and meta-regression of randomized controlled trials. Rheumatology (Oxford). 2016 Aug;55(8):1507-17. doi: 10.1093/rheumatology/kew205. Epub 2016 May 5. |
| 25034472 | Background | Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5. |
| 27977465 | Background | Saltychev M, Laimi K. Effectiveness of repetitive transcranial magnetic stimulation in patients with fibromyalgia: a meta-analysis. Int J Rehabil Res. 2017 Mar;40(1):11-18. doi: 10.1097/MRR.0000000000000207. |
| 31901449 | Background | Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1. |
| 23079535 | Background | Baudic S, Attal N, Mhalla A, Ciampi de Andrade D, Perrot S, Bouhassira D. Unilateral repetitive transcranial magnetic stimulation of the motor cortex does not affect cognition in patients with fibromyalgia. J Psychiatr Res. 2013 Jan;47(1):72-7. doi: 10.1016/j.jpsychires.2012.09.003. Epub 2012 Oct 15. |
| Background | Tekin A, Özdil E, Güleken MD, İlişer R, Bakım B, Öncü J, et al. Efficacy of HighFrequency [10 Hz] Repetitive Transcranial Magnetic Stimulation of the PrimaryMotor Cortex in Patients with Fibromyalgia Syndrome: A Randomized, DoubleBlind, Sham-Controlled Trial. Journal of Musculoskeletal Pain. 2014;22(1):20-26. |
| 19833552 | Background | Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. |
| 32701637 | Derived | Bilir I, Askin A, Sengul I, Tosun A. Effects of High-Frequency Neuronavigated Repetitive Transcranial Magnetic Stimulation in Fibromyalgia Syndrome: A Double-Blinded, Randomized Controlled Study. Am J Phys Med Rehabil. 2021 Feb 1;100(2):138-146. doi: 10.1097/PHM.0000000000001536. |
Group 2 will receive sham stimulation. A total 14 sessions of sham-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Visual Analog Scale-Pain | The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) | Mean | Standard Deviation | units on a scale |
|
| Visual Analog Scale-Stiffness | The severity of the stiffness at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no stiffness, 10=severe stiffness) | Mean | Standard Deviation | units on a scale |
|
| Fibromyalgia Impact Questionnaire | Functional health status and quality of life of the participants were assessed with the Fibromyalgia impact questionnaire, which measures 10 different features (physical functioning, missed days of work, depression, anxiety, feeling good, morning tiredness, pain, stiffness, fatigue, and well-being over the past week). The total Fibromyalgia impact questionnaire score is maximum 80 points. Higher scores indicate lower functionality level. | Mean | Standard Deviation | scores on a scale |
|
| Fatigue Severity Scale | Severity of fatigue was evaluated with Fatigue severity scale, a 9-item self-report questionnaire scale. Each item of this scale consists of statements that are scored on a seven-point Likert type scale ranging from 1 to 7. Total Fatigue severity scale score is calculated as the mean value of nine items. Higher scores indicate higher fatigue severity. (Total score range: 1-7) | Mean | Standard Deviation | scores on a scale |
|
| Hospital Anxiety and Depression Scale | HADS is an assessment tool developed to identify the risk of anxiety and depression and measure its level and change of severity. Its subscales are anxiety and depression. It contains 14 questions in total, including 7 (odd numbers) measuring anxiety and 7 (even numbers) measuring depression. The lowest and highest total score that a person can obtain from this scale are 0 and 42, respectively. High scores are associated with a worse psychiatric condition. | Mean | Standard Deviation | scores on a scale |
|
| Addenbrook Cognitive Examination Revised | Addenbrook Cognitive Examination Revised (ACE-R): ACE-R is a brief cognitive test that consists of 5 basic sections: attention and orientation, memory, verbal fluency, language and visual-spatial abilities. Total score that can be obtained is 0-100. Higher scores are associated with a better cognitive state. | Mean | Standard Deviation | scores on a scale |
|
|
|
| Secondary | Visual Analog Scale-Pain | The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | in the sixth week |
|
|
|
| Secondary | Fibromyalgia Impact Questionnaire | Functional health status and quality of life of the participants were assessed with the Fibromyalgia impact questionnaire, which measures 10 different features (physical functioning, missed days of work, depression, anxiety, feeling good, morning tiredness, pain, stiffness, fatigue, and well-being over the past week). The total Fibromyalgia impact questionnaire score is maximum 80 points. Higher scores indicate lower functionality level. | Posted | Mean | Standard Deviation | score on a scale | in the sixth week |
|
|
|
| Other Pre-specified | Visual Analog Scale-Stiffness | The severity of the stiffness at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no stiffness, 10=severe stiffness) Higher scores mean a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | in the second week |
|
|
|
| Other Pre-specified | Fibromyalgia Impact Questionnaire | Functional health status and quality of life of the participants were assessed with the Fibromyalgia impact questionnaire, which measures 10 different features (physical functioning, missed days of work, depression, anxiety, feeling good, morning tiredness, pain, stiffness, fatigue, and well-being over the past week). The total Fibromyalgia impact questionnaire score is maximum 80 points. Higher scores indicate lower functionality level. | Posted | Mean | Standard Deviation | score on a scale | in the second week |
|
|
|
| Other Pre-specified | Fatigue Severity Scale | Severity of fatigue was evaluated with Fatigue severity scale, a 9-item self-report questionnaire scale. Each item of this scale consists of statements that are scored on a seven-point Likert type scale ranging from 1 to 7. Total Fatigue severity scale score is calculated as the mean value of nine items. Higher scores indicate higher fatigue severity. (Total score range: 1-7) | Posted | Mean | Standard Deviation | score on a scale | in the sixth week |
|
|
|
| Other Pre-specified | Hospital Anxiety and Depression Scale | Hospital anxiety and depression scale is an assessment tool developed to identify the risk of anxiety and depression and measure its level and change of severity. Its subscales are anxiety and depression. It contains 14 questions in total, including 7 (odd numbers) measuring anxiety and 7 (even numbers) measuring depression. The lowest and highest total score that a person can obtain from this scale are 0 and 42, respectively. High scores are associated with a worse psychiatric condition. | Posted | Mean | Standard Deviation | score on a scale | in the sixth week |
|
|
|
| Other Pre-specified | Addenbrook Cognitive Examination Revised | Addenbrook Cognitive Examination-Revised is a brief cognitive test that consists of 5 basic sections: attention and orientation, memory, verbal fluency, language and visual-spatial abilities. Total score that can be obtained is 0-100. Higher scores are associated with a better cognitive state. | Posted | Mean | Standard Deviation | score on a scale | in the sixth week |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Sham rTMS | Group 2 will receive sham daily from Monday to Friday in first 2 weeks. After first 2 weeks there will be sessions once a week for 1 month. There will be 14 sham sessions in total. rTMS + Neuronavigation: Repetitive Transcranial Magnetic Stimulation (Neuro-MS/D) + Neural Navigator | 0 | 10 | 0 | 10 | 0 | 10 |
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| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
| D025321 | Surgery, Computer-Assisted |
| D008919 | Investigative Techniques |