Table 4: Comparison of baseline and follow-up outcomes.
| Patient-reported Outcome, mean (SD) |
Baseline (N=76) |
Follow-up (N=71) |
Mean Change (95% CI) |
P value |
| BPI-SF* |
| Pain Severity Index |
5.2 (1.9) |
5.1 (2.2) |
-0.18 (-0.54, 0.19) |
0.340 |
| Pain at its worst†
|
6.7 (2.0) |
6.4 (2.3) |
-0.23 (-0.72, 0.26) |
0.356 |
| Pain at its least†
|
3.5 (2.3) |
3.8 (2.5) |
0.29 (-0.18, 0.75) |
0.221 |
| Average pain |
5.2 (1.9) |
5.1 (2.1) |
-0.13 (-0.48, 0.22) |
0.468 |
| Pain right now |
5.5 (2.3) |
5.0 (2.6) |
-0.63 (-1.10, -0.16) |
0.009 |
| Pain Interference Index |
5.9 (2.4) |
5.3 (2.4) |
-0.62 (-1.11, -0.14) |
0.013 |
| General activity |
5.6 (2.6) |
5.2 (2.9) |
-0.46 (-1.06, 0.15) |
0.137 |
| Mood |
5.5 (2.7) |
4.8 (2.6) |
-0.76 (-1.41, -0.10) |
0.024 |
| Walking ability |
5.8 (3.2) |
5.4 (3.2) |
-0.40 (-1.11, 0.31) |
0.266 |
| Normal work |
6.1 (2.7) |
5.5 (3.0) |
-0.66 (-1.26, -0.06) |
0.032 |
| Relations with others |
4.6 (3.1) |
4.2 (2.9) |
-0.49 (-1.09, 0.12) |
0.113 |
| Sleep |
7.0 (2.7) |
6.1 (2.9) |
-0.89 (-1.51, -0.26) |
0.006 |
| Enjoyment of life |
6.4 (2.6) |
5.7 (2.7) |
-0.73 (-1.34, -0.11) |
0.021 |
| Modified ACR 2010 Criteria |
| Total Score |
18.4 (5.6) |
16.9 (6.0) |
-1.63 (-2.74, -0.53) |
0.004 |
| Widespread pain index |
10.5 (4.4) |
9.6 (4.8) |
-0.92 (-1.78, -0.05) |
0.038 |
| Symptom severity |
7.8 (2.1) |
7.2 (2.3) |
-0.72 (-1.24, -0.20) |
0.007 |
| FIQ-R‡
|
| Overall Scale |
53.2 (19.3) |
53.2 (20.2) |
-1.94 (-5.41, 1.53) |
0.268 |
| Function |
15.0 (7.4) |
14.7 (7.6) |
-0.82 (-2.10, 0.47) |
0.209 |
| Overall impact |
9.7 (5.9) |
10.3 (6.1) |
-0.12 (-1.23, 0.98) |
0.824 |
| Symptom intensity |
28.5 (7.6) |
28.2 (8.2) |
-1.00 (-2.73, 0.73) |
0.252 |
| MOS-SS |
| Overall Sleep Problems Index |
58.3 (15.7) |
52.7 (16.5) |
-5.27 (-8.79, -1.76) |
0.004 |
| Sleep disturbance |
56.5 (24.1) |
50.3 (24.4) |
-5.60 (-10.87, -0.33) |
0.038 |
| Snoring |
46.1 (34.3) |
44.2 (32.4) |
-2.25 (-9.07, 4.56) |
0.512 |
| Shortness of breath |
26.1 (28.1) |
21.1 (23.2) |
-5.92 (-12.72, 0.89) |
0.088 |
| Sleep adequacy |
25.1 (20.8) |
28.6 (22.1) |
2.82 (-3.62, 9.26) |
0.386 |
| Somnolence |
54.2 (23.7) |
48.7 (20.6) |
-5.73 (-9.71, -1.74) |
0.006 |
| Sleep quantity |
6.2 (1.8) |
6.3 (1.8) |
0.04 (-0.46, 0.55) |
0.868 |
| WPAI |
| Activity Impairment (%) |
58.4 (24.8) |
59.4 (27.0) |
0.56 (-4.37, 5.49) |
0.820 |
| Overall Work Impairment (%)§
|
39.4 (24.9) |
37.9 (20.9) |
1.93 (-8.22, 12.08) |
0.692 |
| Absenteeism |
6.5 (11.9) |
4.9 (16.4) |
-0.91 (-9.39, 7.58) |
0.824 |
| Presenteeism |
36.4 (22.9) |
36.8 (19.5) |
4.12 (-4.02, 12.26) |
0.300 |
| SF-12 |
| Physical Component Summary |
32.8 (10.8) |
34.1 (11.0) |
1.53 (-0.23, 3.30) |
0.088 |
| Mental Component Summary |
41.9 (10.5) |
42.4 (10.9) |
1.13 (-1.15, 3.41) |
0.328 |
| Physical functioning |
33.6 (31.8) |
36.3 (31.8) |
2.82 (-2.80, 8.44) |
0.321 |
| Role physical |
36.2 (26.4) |
41.2 (27.8) |
6.51 (1.20, 11.83) |
0.017 |
| Bodily pain |
40.5 (24.5) |
43.3 (26.4) |
3.52 (-1.41, 8.45) |
0.159 |
| General health |
42.8 (26.7) |
44.9 (24.6) |
3.03 (-0.84, 6.89) |
0.123 |
| Vitality |
23.0 (23.0) |
24.3 (22.0) |
2.82 (-2.53, 8.16) |
0.297 |
| Social functioning |
51.0 (27.8) |
53.5 (27.5) |
4.23 (-2.48, 10.93) |
0.213 |
| Role emotional |
63.2 (26.0) |
63.6 (26.4) |
1.76 (-4.21, 7.73) |
0.558 |
| Mental health |
52.0 (20.3) |
54.4 (23.4) |
3.17 (-2.05, 8.38) |
0.230 |
Abbreviations: BPI-SF, Brief Pain Inventory-Short Form; EQ-5D, EuroQol 5 dimensions, 3 levels; MOS-SS, Medical Outcomes Study-Sleep Scale; pt, point; SD, standard deviation; SF-12, 12-item Short-Form Health Survey; WPAI, Work Productivity and Activity Impairment scale.
*A total of 76 fibromyalgia patients attended the site visit at Follow-up, but 5 patients did not complete the patient questionnaire following the site visit; 1 patient did not report pain at Follow-up and, therefore, did not complete the BPI-SF.
†In the past 24 hours.
‡The FIQ-R was administered only to subjects who had fibromyalgia: Baseline n=74; Follow-up n=59.
§Among those employed for pay, n=25 at Baseline and n=19 at Follow-up.