An interventional study of rTMS + Neuronavigation in Fibromyalgia, sponsored by Izmir Katip Celebi University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-16.
Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Treatment
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.
1,336 studies on the registry are indexed under Fibromyalgia; 265 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 1,034 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Izmir Katip Celebi University is the lead sponsor of 191 studies on the registry; 40 are open to participants now.
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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).
Device: rTMS + Neuronavigation
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).
Device: rTMS + Neuronavigation
Repetitive Transcranial Magnetic Stimulation (Neuro-MS/D) + Neural Navigator
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.
Time frame: in the second week
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.
Time frame: in the sixth week
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.
Time frame: in the sixth week
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.
Time frame: in the second week
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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: in the sixth week
Participants were recruited from Physical Medicine and Rehabilitation (PMR) outpatient clinics of a university hospital.
| Milestone | Active rTMS | Sham rTMS |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| units on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| Visual Analog Scale-Pain | 5.30 ± 2.11 | 6.80 ± 1.69 |
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.
| units on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| Visual Analog Scale-Pain | 5.70 ± 2.63 | 6.70 ± 1.83 |
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.
| score on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| Fibromyalgia Impact Questionnaire | 51.71 ± 22.17 | 56.02 ± 22.57 |
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.
| units on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| Visual Analog Scale-Stiffness | 5.10 ± 2.13 | 6.60 ± 1.96 |
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.
| score on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| Fibromyalgia Impact Questionnaire | 48.35 ± 16.64 | 54.39 ± 15.47 |
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)
| score on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| Fatigue Severity Scale | 4.89 ± 1.59 | 5.39 ± 1.62 |
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.
| score on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| Hospital Anxiety and Depression Scale | 18.80 ± 7.82 | 17.60 ± 10.68 |
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.
| score on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| Addenbrook Cognitive Examination Revised | 66.50 ± 19.67 | 81.40 ± 7.79 |
Collected over 6 weeks (Between the start of the study and the day when the last outcome measure is evaluated). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active rTMS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Sham rTMS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Active rTMS | Sham rTMS | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Active rTMS | Sham rTMS | Total |
|---|---|---|---|
| Mean | 46.70 ± 9.06 | 43.80 ± 9.37 | 45.25 ± 9.08 |
| Sex: Female, Male(Participants) | Active rTMS | Sham rTMS | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Active rTMS | Sham rTMS | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 10 | 10 | 20 |
| Region of Enrollment(Participants) | Active rTMS | Sham rTMS | Total |
|---|---|---|---|
| Turkey | 10 | 10 | 20 |
| Visual Analog Scale-Pain(units on a scale) | Active rTMS | Sham rTMS | Total |
|---|---|---|---|
| Mean | 7.20 ± 1.75 | 7.40 ± 1.35 | 7.30 ± 1.52 |
| Visual Analog Scale-Stiffness(units on a scale) | Active rTMS | Sham rTMS | Total |
|---|---|---|---|
| Mean | 7.40 ± 1.58 | 7.60 ± 1.17 | 7.50 ± 1.35 |
| Fibromyalgia Impact Questionnaire(scores on a scale) | Active rTMS | Sham rTMS | Total |
|---|---|---|---|
| Mean | 65.86 ± 8.27 | 66.44 ± 11.40 | 66.15 ± 9.69 |
3 further baseline measures are reported on the registry.
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Izmir Katip Celebi University