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. 2013 Sep 3;2013:962741. doi: 10.1155/2013/962741

Table 1.

Main study characteristics.

Author;
country;
year;
setting;
referral or recruitment 		Mean age;  
female %;
race %		 Diagnosis of FMS1 Study population Treatment group Control group Both groups Outcomes used for meta-analysis
latest follow up
N screened/N randomized (%);
N completing therapy (%)		 Type of treatment;  
duration of treatment;
N at baseline/N completing therapy (%)
 Type of treatment;  
duration of treatment;
N at baseline/N completing therapy (%)		 Comedication allowed;
attendance rates (all sessions);
side effects;
drop out due to side effects in treatment group
Babu et al.;
India;  
2007;  
outpatient;
not reported 
[34]		 39;  
70%; 
Not reported
 ACR2 criteria Not reported/30;
30 (100%) 
 EMG-BFB3;  
6 individual sessions of 45 minutes;  
15/15 (100%)		 Sham EMG-BFB;  
6 individual sessions of 45 minutes;  
15/15 (100%)		 not reported;  
not reported;  
not reported;  
not reported		 Pain VAS4 0–10* 
Sleep VAS 0–10** 
Fatigue VAS 0–10** 
Depression VAS 0–10** 
HRQOL5 
FIQ6 
Total VAS 0–80*No follow-up
Buckelew et al.;
7USA;  
1998;  
outpatient;
university hospital, private practice 
[33]		 44;  
90.8%; 
not reported
 Yunus criteria 240/119 (49.6%); 
109 (91%)		 EMG-BFB and relaxation;
6-week individual treatment once a week for 1.5–3 hours;  
29/27
(93.1%)		 Attention control;  
6-week individual treatment once a week for 1.5–3 hours; 30/28 (93.3%)		 Yes 
not reported;  
not reported;  
not reported		 Pain VAS 0–10* 
Sleep VAS 0–10* 
Fatigue NA8 
Depression CES9∗ 
HRQOL NA
24 months
Ferraccioli et al.;  
Italy;
1987;
outpatient;
consecutive patients at an outpatient clinic 
[35]		 57;  
100%; 
not reported		 Not exactly specified Not reported/12;  12/12 (100%) EMG-BFB;
15 sessions, two sessions a week;  
6/6 (100%)		 Sham EMG-BFB; 15 sessions; 6/6 (100%) Allowed;  
not reported;  
not reported;  
none		 Pain VAS 0–10 
Sleep NA
Fatigue NA 
Fatigue NA 
Depression NA 
HRQOL NA
No follow-up
Kayiran et al.;
Turkey;
2010;
outpatient; consecutive patients at an outpatient clinic 
[39]		 32;  
100%; 
not reported		 ACR 
criteria		 Not reported/40;  36 completing the first follow-up (90%) EEG-BFB10; 20 individual sessions of 30 minutes;  
20/18 completing the first follow-up (90%)		 Escitalopram (an SSRI11) 10 mg/day;  
8 weeks;  
20/18 completing the first follow-up (90%)		 not allowed;  
not reported;  
not reported;  
not reported		 Pain VAS 0–10 
Sleep NA 
Fatigue VAS 0–10 
Depression BDI12 
(NRS13 0–63)  
HRQOL 
FIQ 
Total VAS 0–80
4 months
Kravitz et al.;
USA;
2006;
outpatient;
at two private practices and via advertisement and self-help groups 
[36]		 46.9;  
92%; 
92% white		 ACR 
criteria		 159/64 (40.3%); 
59 (92.2%)		 EEG-BFB;  
22 sessions;  
33/31 (93, 9%)		 Sham EEG-BFB;
22 sessions; 31/28 (90.3%)		 Morphines, SSRIs, and Benzodiazepines not allowed, other medication allowed;
74% reported side effects of EEG-BFB, e.g. fatigue, headache and sleep problems;  
not reported		 Pain VAS 0–10
Sleep VAS 0–10
Fatigue VAS 0–10
Depression VAS 0–10
HRQOL
FIQ
Total VAS 0–80** 
1 week
Nelson et al.;
USA;
2010;
outpatient;
FMS database and advertisement 
[38]
 51.6;
100%;
88.2% white		 ACR
criteria		 82/42 (51.2%);
34 (81%)		 EEG-BFB;
22 sessions; 
21/17 (81%)		 Sham EEG-BFB; 22 sessions;
21/17 (81%)		 Allowed;
not reported;  
none;
none		 Pain VAS 0–10* 
Fatigue VAS 0–10* 
Sleep MOS Sleep14 
NRS 0–100 
Depression PHQ 915 
HRQOL 
FIQ 
Total VAS 0–80
6 months
Van Tulder et al.;  
the Netherlands;   2001;  
 outpatient; 
central registry 
[8]		 46.216;  
 100%; 
 not reported		 ACR 
criteria		 268/14317 (53.4%); 
118 (82.5%)		 EMG-BFB;  
16 sessions;  
50/43 (86%)		 Treatment as usual; consecutive medical care; 29/28 (96.55%) Allowed;  
88% of patients attended 67% of BFB sessions;  
2 patients reported stress due to BFB18;  
2 patients		 Pain VAS 0–10 
Sleep NA 
Fatigue VAS 0–100 
Depression NA
HRQOL SIP19 
Total (NRS 0–100)
6 months

1FMS: fibromyalgia syndrome; 2ACR: American College of Rheumatology; 3EMG-BFB: electromyography biofeedback; 4VAS: visual analogue scale; 5HRQOL: health-related quality of life; 6FIQ: Fibromyalgia Impact questionnaire; 7The study included 4 different conditions. The analysis was performed with two of these conditions (Biofeedback and attention control); the numbers represent all four groups; 8NA: not assessed; 9CES: center for Epidemiological Studies Depression Scale; 10EEG-BFB: electroencephalography biofeedback (Neurofeedback); 11SSRI: selective serotonin reuptake inhibitor (an antidepressant); 12BDI: Beck Depression Inventory; 13NRS: Numeric Rating Scale; 14MOS: Medical Outcomes Study Sleep Scale; 15PHQ 9: Patient Health Questionnaire, 16In the BFB group; 17the study included 3 different conditions. The analysis was performed with two of these conditions (biofeedback and treatment as usual control); the numbers represent all three groups. 18BFB: biofeedback; 19SIP: sickness impact profile.

Note: Studies are presented in alphabetical order.

*Data provided on request.

**Data not provided on request.