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6 of 9

Craniosacral Therapy in Patients with Fibromyalgia

BP

75.76

(7.20)

78.43

(12.75)

0.257

73.12

(6.08)

78.00

(13.07)

0.036*

74.25

(6.74)

78.65

(13.22)

0.052

74.84

(7.04)

77.39

(10.65)

0.234

GH

67.02

(4.25)

68.28

(6.84)

0.258

64.40

(4.65)

68.35

(6.39)

0.048*

66.02

(4.12)

67.92

(6.69)

0.087

66.72

(5.21)

67.63

(7.02)

0.321

SF

63.23

(7.12)

63.93

(12.41)

0.758

58.75

(6.74)

63.50

(11.57)

0.028*

59.85

(10.93)

63.05

(11.87)

0.075

60.45

(8.67)

64.45

(10.29)

0.067

RE

49.18

(7.65)

46.35

(5.69)

0.065

45.60

(7.85)

47.23

(5.66)

0.292

49.65

(6.52)

46.40

(5.96)

0.053

48.33

(8.31)

47.42

(7.29)

0.135

PF

49.43 (6.90)

51.90 (9.92)

0.199

45.90 (5.87) 50.53 (9.12)

0.009* 46.05 (4.61)

49.05 (8.03)

0.049* 47.43 (5.32) 50.68 (7.54)

0.367

PR

25.17

(6.88)

25.86 (7.35)

0.661

22.10 (6.84) 25.80 (6.98)

0.019* 23.85 (7.05)

25.47

(7.09)

0.067

24.67

(7.24)

26.01

(7.83)

0.121

P 3a-PT

Values are presented as means and standard deviations (SD). IG, intervention group; PG, placebo group; Pre-T, pre-therapy; 1a PT, post-therapy after 25 weeks of treatment; 2a PT, post-therapy at 6 months after end of treatment; 3a PT, post-therapy at 1 year after end of treatment; PF, physical function; PR, physical role; BP, body pain; GH, general health; V, vitality; SF, social function; ER, emotional role; MH, mental health. *P ¼ 0.05 (95% CI).

P

1 year M (SD)

2a-PT

IG PG

Table 2. Differences in quality of life (SF-36 questionnaire) between study groups

V

58.90 (6.27)

MH

76.65 (11.23) 80.60 (9.66)

0.376 62.73 (5.27) 59.48 (7.73)

0.046* 60.80 (5.11)

58.72 (7.78)

0.050* 61.34 (4.96) 59.01 (5.74)

0.201

0.097 77.48 (8.73) 81.15 (10.42) 0.069

74.15 (12.12) 77.80 (7.84)

0.074

75.64 (9.86) 79.45 (10.35) 0.083

P

25 weeks M (SD)

Pre-T

IG PG

60.05

(5.23)

Baseline M (SD)

SF-36 IG

PG

P

6 months M (SD))

1a-PT

IG PG

PSQ 0

12

31 2

13

26 0.064 0

10

33 5

18

18 0.043*

SL

2

6

35 2

7

32 0.948 0

22

21 1

12

28 0.064

SD

1

12

30 2

5

34 0.059 0

19

24 0

10

31 0.042*

HSE

1

15

27 0

10

31 0.255 0

20

23 0

13

28 0.065

SDI

0

17

26 3

14

24 0.191 0

27

16 4

10

27 0.040*

DD

0

34

90

31

10 0.592 3

35

50

29

12 0.065

PSQ 5

SL

4

SD

2

HSE

4

SDI

0

DD

6

13

25 7

18

16 0.093 4

11

28 6

19

16 0.054

18

21 2

14

25 0.105 2

18

23 3

14

24

0.132

16

25 3

7

31 0.039* 1

17

25 2

6

33

0.040*

19

20 0

14

27 0.047* 2

20

21 0

13

28

0.044*

21

22 4

11

26 0.045* 0

19

24 2

13

26

0.088

21

16 0

24

17 0.240 3

18

22 1

28

12

0.039*

Table 3. Differences between study groups in Pittsburgh sleep quality index score at baseline and after therapy

P 1a-PT

Table 4. Differences between study groups in Pittsburgh sleep quality index at 6 months and 1 year after treatment

P 3a-PT

IG PG

IG PG

PSQI NP MP SP NP MP SP

NP MP SP NP MP SP

Baseline (n)

PSQI NP MP SP NP MP SP

NP MP SP NP MP SP

P Pre-T

25 weeks (n)

6 months (n ¼ number

of patients) IG

PG

P

1 year (n ¼ number

2a-PT of patients) IG

PG

Values are shown as n ¼ number of patients with no problems, moder- ate problems, severe problems. PSQI, Pittsburgh sleep quality index; IG, intervention group; PG, placebo group; Pre-T, pre-therapeutic; 1a PT, post-therapy (after 25 weeks of treatment); PSQ, Pittsburgh subjective quality; SL, sleep latency; SD, sleep duration; HSE, habitual sleep efficiency; SDI, sleep disturbance; DD, daily dysfunction; NP, no problems; MP, moderate problems; SP, severe problems. *P ¼ 0.05 (95% CI).

Values are shown as n ¼ number of patients with no problems, moder- ate problems, severe problems. PSQI, Pittsburgh sleep quality index; IG, intervention group; PG, placebo group; Pre-T, pre-therapy; 2a PT, post-therapy at 6 months after end of treatment; 3a PT, post-therapy at 1 year after end of treatment; PSQ, Pittsburgh subjective quality; SL, sleep latency; SD, sleep duration; HSE, habitual sleep efficiency; SDI, sleep disturbance; DD, daily dysfunction; NP, does not present problems; MP, moderate problems; SP, severe problems. *P ¼ 0.05 (95% CI).

inventory score (r ¼ 0.374; P ¼ 0.027), overall SF-36 score and VAS score (r ¼ 0.431; P ¼ 0.015), and between physical role and VAS score (r ¼ 0.564; P ¼ 0.021), body pain (r ¼ 0.378; P ¼ 0.016) and mental health (r ¼ 0.385; P ¼ 0.024).

score (r ¼ 0.331; P ¼ 0.048) and between trait anxiety score and Beck depression score (r ¼ 0.323; P ¼ 0.045).

One Year Post-intervention

Six Months Post-intervention

No significant intra-group or inter-group differences were found in state anxiety, depression or pain with respect to baseline. The intervention group showed a significant improvement (versus baseline) in physical function (P50.041). The placebo group showed no differences (versus baseline) in any SF-36 questionnaire item. The groups differed significantly in physical function (P50.049) and vitality (P50.050). The groups also dif- f e r e d s i g n i f i c a n t l y i n s l e e p d u r a t i o n ( P 5 0 . 0 3 9 ) , h a b i t u a l and sleep disturbance sleep efficiency (P50.047) (P50.045) (Table 4). In the intervention group , correlations were found

between overall SF-36 questionnaire score and VAS

At 1 year, the intervention group showed a significant improvement (versus baseline) in sleep duration (P50.040), habitual sleep efficiency (P50.044) and daily dysfunction (P50.039) (Table 4). No significant differences in anxiety, depression, pain or quality of life were found between groups or with respect to baseline values.

In the intervention group, trait anxiety was correlated with Beck depression score (r ¼ 0.311; P ¼ 0.047).

Discussion

We examined the efficacy of craniosacral treatment on anxiety, depression and quality of life in patients

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