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Craniosacral Therapy in Patients with Fibromyalgia

the ultrasound was covered to ensure that the patient was unaware that the equipment was disconnected..

Both patient groups were instructed not to change their pharmacological treatment during the 25-week study period.

Statistical Analysis

The SPSS package (version 17.0) was used for the data analyses. After performing descriptive statistics of variables at baseline, the Kolmogorov–Smirnof test was applied to evaluate the normal distribution of variables. Continuous data were expressed as means SD. A paired t-test was used to examine changes in scores between baseline and follow-up examinations. Inter- group differ- ences in variables were analyzed by using repeated- measures analysis of variance. Relationships between demographic variables (sex and age group), aggravating factors, work activity, diseases related to fibromyalgia syndrome, VAS pain score, dimensions of the SF-36 health survey for quality of life, dimensions of the Pittsburgh sleep quality index, total Beck depression inventory score and state and trait anxiety scores were evaluated by calculating Pearson correlation coefficients. A 95% confidence interval (CI) (a ¼ 0.05) was considered in all tests.

Results

During the study, 9 patients withdrew from the interven- tion group and 11 from the placebo group. Reasons for withdrawal were death of spouse, start of another type of

Female

95.35

97.56

0.529

Male

4.65

2.44

0.052

Emotional factors

100

100

1.000

Stress

42

50

0.086

Work involving standing 46.32

49.48

0.194

Cold

100

100

1.000

Full-time

12

18

0.098

Part-time

34

26

0.067

Sick leave

11

21

0.051

Unemployed

43

35

0.069

treatment, change in pharmacologic therapy during treat- ment period, and missing sessions due to acute pain crisis and forgetfulness. The final study sample comprised 84 patients (81 females) aged 34–63 years with a mean age of 49.08 14.17 years (Fig. 1). There were no differ- ences in baseline demographic characteristics between the intervention group (n ¼ 43) and placebo group (n ¼ 41) (Table 1). The groups did not differ significantly in state anxiety (P50.320), trait anxiety (P50.269) or VAS (P50.239) scores but differed in all dimensions of the SF-36 questionnaire with the exception of vitality.

Work activity (%)

Arthritis

6.23

8.77

0.119

Chorea

2.13

3.87

0.201

Type I diabetes

3.25

5.75

0.127

Type II diabetes

7

8

0.845

Ulcerous colitis

6.5

3.5

0.075

Aggravating factors (%)

Diseases related to fibromyalgia syndrome (%)

P ¼ 0.05 between intervention and placebo groups.

Table 1. Baseline and demographic characteristics of study groups

Characteristics Age mean (SD)

Sex (%)

Intervention (n ¼ 43) Placebo (n ¼ 41) P

48.25 (13.34)

52.26 (10.98)

0.069

Initial Sample (n =119)

Excluded (n =15) Failure to meet inclusion criteria (n =12)

Randomisation

Refusal to participate (n =1) Other reasons (n =2)

Intervention Group

Placebo Group

Assigned to intervention (n = 52)

Assigned to intervention (n =52)

Underwent the assigned intervention (n = 43)

Underwent the assigned intervention (n = 41)

Figure 1. Flow of participants in the study. None of the 84 participants reported adverse effects.

Follow-up during 25 weeks of intervention

Follow-up during 25 weeks of intervention

Analysed (n = 43)

Analysed (n = 41)

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