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Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation (rTMS) in Fibromyalgia (NCT NCT03909009)

NCT ID: NCT03909009

Last Updated: 2020-06-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

in the second week

Results posted on

2020-06-16

Participant Flow

Participants were recruited from Physical Medicine and Rehabilitation (PMR) outpatient clinics of a university hospital.

Twenty-eight patients were evaluated for participation in the study. Eight patients were excluded.

Participant milestones

Participant milestones
Measure
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).
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).
Overall Study
STARTED
10
10
Overall Study
COMPLETED
10
10
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Repetitive Transcranial Magnetic Stimulation (rTMS) in Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active rTMS
n=10 Participants
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
n=10 Participants
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).
Total
n=20 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
46.70 years
STANDARD_DEVIATION 9.06 • n=5 Participants
43.80 years
STANDARD_DEVIATION 9.37 • n=7 Participants
45.25 years
STANDARD_DEVIATION 9.08 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Region of Enrollment
Turkey
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Visual Analog Scale-Pain
7.20 units on a scale
STANDARD_DEVIATION 1.75 • n=5 Participants
7.40 units on a scale
STANDARD_DEVIATION 1.35 • n=7 Participants
7.30 units on a scale
STANDARD_DEVIATION 1.52 • n=5 Participants
Visual Analog Scale-Stiffness
7.40 units on a scale
STANDARD_DEVIATION 1.58 • n=5 Participants
7.60 units on a scale
STANDARD_DEVIATION 1.17 • n=7 Participants
7.50 units on a scale
STANDARD_DEVIATION 1.35 • n=5 Participants
Fibromyalgia Impact Questionnaire
65.86 scores on a scale
STANDARD_DEVIATION 8.27 • n=5 Participants
66.44 scores on a scale
STANDARD_DEVIATION 11.40 • n=7 Participants
66.15 scores on a scale
STANDARD_DEVIATION 9.69 • n=5 Participants
Fatigue Severity Scale
5.28 scores on a scale
STANDARD_DEVIATION 1.23 • n=5 Participants
6.08 scores on a scale
STANDARD_DEVIATION 1.11 • n=7 Participants
5.68 scores on a scale
STANDARD_DEVIATION 1.20 • n=5 Participants
Hospital Anxiety and Depression Scale
19.30 scores on a scale
STANDARD_DEVIATION 8.14 • n=5 Participants
22.90 scores on a scale
STANDARD_DEVIATION 5.61 • n=7 Participants
21.10 scores on a scale
STANDARD_DEVIATION 7.04 • n=5 Participants
Addenbrook Cognitive Examination Revised
62.50 scores on a scale
STANDARD_DEVIATION 18.80 • n=5 Participants
76.90 scores on a scale
STANDARD_DEVIATION 11.17 • n=7 Participants
69.70 scores on a scale
STANDARD_DEVIATION 16.76 • n=5 Participants

PRIMARY outcome

Timeframe: in the second week

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.

Outcome measures

Outcome measures
Measure
Active rTMS
n=10 Participants
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
n=10 Participants
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).
Visual Analog Scale-Pain
5.30 units on a scale
Standard Deviation 2.11
6.80 units on a scale
Standard Deviation 1.69

SECONDARY outcome

Timeframe: in the sixth week

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.

Outcome measures

Outcome measures
Measure
Active rTMS
n=10 Participants
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
n=10 Participants
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).
Visual Analog Scale-Pain
5.70 units on a scale
Standard Deviation 2.63
6.70 units on a scale
Standard Deviation 1.83

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Active rTMS
n=10 Participants
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
n=10 Participants
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).
Fibromyalgia Impact Questionnaire
51.71 score on a scale
Standard Deviation 22.17
56.02 score on a scale
Standard Deviation 22.57

OTHER_PRE_SPECIFIED outcome

Timeframe: in the second week

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.

Outcome measures

Outcome measures
Measure
Active rTMS
n=10 Participants
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
n=10 Participants
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).
Visual Analog Scale-Stiffness
5.10 units on a scale
Standard Deviation 2.13
6.60 units on a scale
Standard Deviation 1.96

OTHER_PRE_SPECIFIED outcome

Timeframe: in the second 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.

Outcome measures

Outcome measures
Measure
Active rTMS
n=10 Participants
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
n=10 Participants
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).
Fibromyalgia Impact Questionnaire
48.35 score on a scale
Standard Deviation 16.64
54.39 score on a scale
Standard Deviation 15.47

OTHER_PRE_SPECIFIED outcome

Timeframe: in the sixth week

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)

Outcome measures

Outcome measures
Measure
Active rTMS
n=10 Participants
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
n=10 Participants
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).
Fatigue Severity Scale
4.89 score on a scale
Standard Deviation 1.59
5.39 score on a scale
Standard Deviation 1.62

OTHER_PRE_SPECIFIED outcome

Timeframe: in the sixth week

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.

Outcome measures

Outcome measures
Measure
Active rTMS
n=10 Participants
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
n=10 Participants
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).
Hospital Anxiety and Depression Scale
18.80 score on a scale
Standard Deviation 7.82
17.60 score on a scale
Standard Deviation 10.68

OTHER_PRE_SPECIFIED outcome

Timeframe: in the sixth week

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.

Outcome measures

Outcome measures
Measure
Active rTMS
n=10 Participants
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
n=10 Participants
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).
Addenbrook Cognitive Examination Revised
66.50 score on a scale
Standard Deviation 19.67
81.40 score on a scale
Standard Deviation 7.79

Adverse Events

Active rTMS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham rTMS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Doç.Dr. Ayhan AŞKIN

Izmir Katip Çelebi University, Faculty of Medicine

Phone: 00902322444444

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place