Background
Methods
Study Design
Subject Questionnaire
Statistical Analysis
Results
Demographic Characteristics
Severity Level | |||||
---|---|---|---|---|---|
Characteristic
|
Overall
(n = 203)
|
Mild
(n = 21)
|
Moderate
(n = 49)
|
Severe
(n = 133)
|
p-value
a
|
Age, years | 0.148 | ||||
mean (SD) | 47.9 (10.9) | 48.6 (11.9) | 45.3 (11.0) | 48.7 (10.6) | |
median | 50.0 | 53.0 | 46.0 | 50.0 | |
range | 19.0 - 65.0 | 28.0 - 65.0 | 19.0 - 64.0 | 21.0 - 65.0 | |
Gender, n (%) | 0.621 | ||||
Male | 11 (5.4) | 2 (9.5) | 3 (6.1) | 6 (4.5) | |
Female | 192 (94.6) | 19 (90.5) | 46 (93.9) | 127 (95.5) | |
Employment status, n (%) | < 0.001 | ||||
Employed, full-time | 57 (28.1) | 13 (61.9) | 18 (36.7) | 26 (19.5) | |
Employed, part-time | 26 (12.8) | 2 (9.5) | 12 (24.5) | 12 (9.0) | |
Disabled | 55 (27.1) | 0 (0.0) | 7 (14.3) | 48 (36.1) | |
Full-time homemaker | 25 (12.3) | 4 (19.0) | 5 (10.2) | 16 (12.0) | |
Unemployed | 16 (7.9) | 1 (4.8) | 1 (2.0) | 14 (10.5) | |
Retired | 12 (5.9) | 1 (4.8) | 3 (6.1) | 8 (6.0) | |
Other | 8 (3.9) | 0 (0.0) | 2 (4.1) | 6 (4.5) | |
Student | 4 (2.0) | 0 (0.0) | 1 (2.0) | 3 (2.3) |
Clinical Characteristics
Severity Level | |||||
---|---|---|---|---|---|
Characteristic
|
Overall
(n = 203)
|
Mild
(n = 21)
|
Moderate
(n = 49)
|
Severe
(n = 133)
|
p-value
a
|
Time since first experienced FM symptoms, years | 0.684 | ||||
mean (SD) | 10.7 (8.1) | 10.8 (6.3) | 10.1 (8.1) | 10.9 (8.3) | |
median (range) | 9.0 (0.0 - 48.0) | 10.0 (3.0 - 23.0) | 9.0 (1.0 - 32.0) | 9.0 (0.0 - 48.0) | |
Time since diagnosis, years | |||||
mean (SD) | 6.9 (6.5) | 7.4 (6.1) | 6.2 (6.2) | 7.0 (6.6) | 0.604 |
median (range) | 6.0 (0.0 - 48.0) | 6.0 (0.0 - 22.0) | 4.0 (0.0 - 30.0) | 6.0 (0.0 - 48.0) | |
Time since first prescription for FM, years | 0.670 | ||||
mean (SD) | 6.3 (6.2) | 7.2 (6.6) | 5.9 (6.6) | 6.2 (6.0) | |
median (range) | 4.5 (0.0 - 30.0) | 5.0 (0.0 - 22.0) | 3.0 (0.0 - 30.0) | 5.0 (0.0 - 21.0) | |
Number of positive MTPS points | 0.036 | ||||
mean (SD) | 14.7 (3.4) | 13.7 (4.1) | 13.8 (3.8) | 15.2 (3.0) | |
median (range) | 16.0 (4.0 - 18.0) | 16.0 (5.0 - 18.0) | 15.0 (4.0 -18.0) | 16.0 (4.0 - 18.0) | |
Number of comorbid conditionsb
| 0.112 | ||||
mean (SD) | 4.2 (2.4) | 2.9 (1.6) | 4.1 (2.3) | 4.4 (2.6) | |
median (range) | 4.0 (1.0-10.0) | 3.0 (1.0-7.0) | 4 (1.0-10.0) | 4.0 (1.0-10.0) | |
Average pain intensity, n (%) | < 0.001 | ||||
Mild (0-3) | 20 (9.9) | 12 (57.1) | 7 (14.3) | 1 (0.8) | |
Moderate (4-6) | 74 (36.6) | 6 (28.6) | 24 (49.0) | 44 (33.3) | |
Severe (7-10) | 108 (53.5) | 3 (14.3) | 18 (36.7) | 87 (65.9) | |
Number of physician visits (per year) | < 0.001 | ||||
mean (SD) | 16.9 (17.9) | 9.7 (11.3) | 11.6 (11.2) | 19.9 (19.9) | |
median (range) | 12.0 (4.0 - 132.0) | 4.0 (4.0 - 48.0) | 8.0 (4.0 - 52.0) | 16.0 (4.0 - 132.0) | |
Number of medications over the past 3 months, n (%) | |||||
≥ 1 medication | 37 (91.6) | 19 (90.5) | 43 (87.8) | 124 (93.2) | 0.487 |
≥ 3 medications | 48 (47.3) | 3 (14.3) | 22 (44.9) | 71 (53.4) | 0.004 |
Comorbid Conditions
Severity Level | |||||
---|---|---|---|---|---|
Comorbid condition, n (%)
a
|
Total
(n = 203)
|
Mild
(n = 21)
|
Moderate
(n = 49)
|
Severe
(n = 133)
|
p-value
b
|
Sleep disturbance/Insomnia | 138 (68.0) | 11 (52.4) | 35 (71.4) | 92 (69.2) | 0.259 |
Depressive Symptoms | 117 (57.6) | 5 (23.8) | 20 (40.8) | 92 (69.2) | < 0.001 |
Headache/migraine | 105 (51.7) | 10 (47.6) | 26 (53.1) | 69 (51.9) | 0.915 |
Anxiety | 101 (49.8) | 4 (19.0) | 20 (40.8) | 77 (57.9) | 0.002 |
Chronic Fatigue Syndrome | 86 (42.4) | 2 (9.5) | 26 (53.1) | 58 (43.6) | 0.003 |
Irritable Bowel Syndrome | 74 (36.5) | 5 (23.8) | 17 (34.7) | 52 (39.1) | 0.384 |
Restless Leg Syndrome | 58 (28.6) | 3 (14.3) | 16 (32.7) | 39 (29.3) | 0.281 |
Cognitive Dysfunction | 55 (27.1) | 2 (9.5) | 15 (30.6) | 38 (28.6) | 0.154 |
Major Depressive Disorder | 47 (23.2) | 0 (0.0) | 11 (22.4) | 36 (27.1) | 0.024 |
Raynaud's Syndrome | 15 (7.4) | 2 (9.5) | 5 (10.2) | 8 (6.0) | 0.584 |
Impact of FM on Health-Related Quality of Life and Core FM Symptoms
Areas of Daily Life Impacted by FM n (%) | Severity Level | ||||
---|---|---|---|---|---|
Total
(n = 203)
|
Mild
(n = 21)
|
Moderate
(n = 49)
|
Severe
(n = 133)
|
p-value
a
| |
Pain | 183 (90.6) | 19 (90.5) | 43 (89.6) | 121 (91.0) | 0.960 |
Lack of energy/fatigue | 175 (86.6) | 5 (23.8) | 23 (47.9) | 75 (56.4) | 0.019 |
Sleep disturbance | 109 (54.0) | 17 (81.0) | 44 (91.7) | 114 (85.7) | 0.421 |
Difficulty moving, walking, or exercising | 103 (51.0) | 13 (61.9) | 24 (50.0) | 72 (54.1) | 0.658 |
Limited daily life and household activities | 92 (45.5) | 9 (42.9) | 14 (29.2) | 32 (24.1) | 0.187 |
Stiffness | 85 (42.1) | 13 (61.9) | 31 (64.6) | 41 (30.8) | < 0.001 |
Depression | 81 (40.1) | 12 (57.1) | 20 (41.7) | 45 (33.8) | 0.105 |
Tender at touch | 77 (38.1) | 4 (19.0) | 16 (33.3) | 61 (45.9) | 0.036 |
Problems with attention | 55 (27.2) | 2 (9.5) | 3 (6.3) | 29 (21.8) | 0.030 |
Anxiety | 34 (16.8) | 6 (28.6) | 22 (45.8) | 64 (48.1) | 0.247 |
Other | 9 (4.5) | 1 (4.8) | 0 (0.0) | 8 (6.0) | 0.223 |
Severity Level | |||||
---|---|---|---|---|---|
Scale
|
Overall
(N = 203)
|
Mild
(N = 21)
|
Moderate
(N = 49)
|
Severe
(N = 133)
|
p-value
a
|
EQ-5D
| |||||
Health State Valuation | < 0.001 | ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 0.35 (0.35) | 0.76 (0.11) | 0.57 (0.21) | 0.20 (0.31) | |
median (range) | 0.52 (0.2- 1.0) | 0.76 (0.6 - 1.0) | 0.62 (0.0 - 1.0) | 0.09 (0.2 - 0.8) | |
Overall Health Status
Ratings
| |||||
Current Overall Health | < 0.001 | ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 54.9 (21.0) | 71.0 (21.5) | 62.7 (16.9) | 49.4 (20.1) | |
median (range) | 50.0 (2.0- 100.0) | 75.0 (10.0 - 95.0) | 65.0 (10.0 - 90.0) | 50.0 (2.0 - 100.0) | |
Pain-Free Overall Health | 0.001 | ||||
n | 202 | 21 | 49 | 132 | |
mean (SD) | 79.3 (20.4) | 84.6 (23.9) | 84.2 (19.4) | 76.6 (19.8) | |
median (range) | 89.5 (0.0-100.0) | 90.0 (10.0 - 100.0) | 90.0 (0.0 - 100.0) | 80.0 (15.0 - 100.0) | |
Average Pain Intensity
| < 0.001 | ||||
n | 202 | 21 | 49 | 132 | |
mean (SD) | 6.3 (2.1) | 3.4 (2.0) | 5.6 (1.8) | 7.0 (1.6) | |
median (range) | 7.0 (1.0-100.0) | 3.0 (1.0 - 7.0) | 6.0 (2.0 - 8.0) | 7.0 (3.0 - 10.0) | |
FIQ
| n/ab
| ||||
Total Score | |||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 63.2 (19.0) | 23.9 (9.5) | 49.3 (5.1) | 74.5 (9.1) | |
median (range) | 67.4 (6.0-99.0) | 25.9 (6.0 - 38.1) | 48.6 (39.9 - 58.9) | 73.4 (59.1 - 99.0) | |
Physical Impairment | n/ab
| ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 5.1 (2.4) | 2.4 (2.6) | 3.8 (2.1) | 6.0 (1.8) | |
median (range) | 5.0 (0.0-10.0) | 1.0 (0.0 - 10.0) | 4.0 (0.0 - 10.0) | 6.0 (0.0 - 10.0) | |
Feel Good | n/ab
| ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 7.1 (2.8) | 3.1 (2.9) | 6.0 (2.3) | 8.2 (2.1) | |
median (range) | 7.1 (0.0-10.0) | 2.9 (0.0 - 10.0) | 5.7 (0.0 - 10.0) | 8.6 (0.0 - 10.0) | |
Work Missed | n/ab
| ||||
n | 202 | 21 | 49 | 132 | |
mean (SD) | 4.5 (3.5) | 0.9 (2.3) | 2.2 (2.3) | 5.9 (3.2) | |
median (range) | 4.3 (0.0-10.0) | 0.0 (0.0 - 10.0) | 1.4 (0.0 - 10.0) | 6.4 (0.0 - 10.0) | |
Do Work | n/ab
| ||||
n | 201 | 21 | 49 | 131 | |
mean (SD) | 6.4 (2.7) | 1.8 (1.6) | 4.7 (1.8) | 7.8 (1.6) | |
median (range) | 7.0 (0.0-10.0) | 2.0 (0.0 - 5.0) | 5.0 (0.0 - 7.0) | 8.0 (4.0 - 10.0) | |
Pain | n/ab
| ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 7.0 (2.3) | 3.0 (1.6) | 6.0 (1.8) | 7.9 (1.6) | |
median (range) | 7.0 (1.0-10.0) | 3.0 (1.0 - 7.0) | 6.0 (2.0 - 9.0) | 8.0 (3.0 - 10.0) | |
Fatigue/Tired | n/ab
| ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 7.9 (2.3) | 3.5 (2.0) | 6.8 (1.9) | 8.9 (1.2) | |
median (range) | 8.0 (0.0-10.0) | 4.0 (0.0 - 7.0) | 7.0 (3.0 - 10.0) | 9.0 (4.0 - 10.0) | |
Rested | n/ab
| ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 7.9 (2.3) | 4.1 (2.3) | 7.1 (1.8) | 8.8 (1.6) | |
median (range) | 8.0 (0.0-10.0) | 5.0 (0.0 - 8.0) | 7.0 (3.0 - 10.0) | 9.0 (2.0 - 10.0) | |
Stiffness | n/ab
| ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 7.2 (2.4) | 3.6 (2.3) | 6.4 (1.7) | 8.1 (1.9) | |
median (range) | 8.0 (0.0-10.0) | 3.0 (0.0 - 9.0) | 6.0 (2.0 - 10.0) | 9.0 (2.0 - 10.0) | |
Anxiety | n/ab
| ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 5.1 (3.2) | 1.1 (1.7) | 3.2 (2.2) | 6.4 (2.8) | |
median (range) | 5.0 (0.0-10.0) | 0.0 (0.0 - 6.0) | 3.0 (0.0 - 7.0) | 7.0 (0.0 - 10.0) | |
Depression | n/ab
| ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 5.1 (3.2) | 0.6 (0.8) | 3.2 (2.4) | 6.5 (2.6) | |
median (range) | 6.0 (0.0-10.0) | 0.0 (0.0 - 2.0) | 3.0 (0.0 - 9.0) | 7.0 (0.0 - 10.0) | |
MOS Sleep
| |||||
Sleep Problems Index | < 0.001 | ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 57.5 (18.4) | 34.4 (13.6) | 50.7 (16.9) | 63.7 (15.6) | |
median (range) | 58.3 (13.3-95.6) | 33.9 (13.3 - 65.6) | 47.8 (20.6 - 88.9) | 65.0 (24.4 - 95.6) | |
Sleep Disturbance | < 0.001 | ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 56.4 (25.3) | 31.6 (22.5) | 49.0 (22.0) | 63.1 (23.8) | |
median (range) | 56.3 (5.0-100.0) | 26.3 (5.0 - 78.8) | 42.5 (10.0 - 100.0) | 66.3 (5.0 - 100.0) | |
Sleep Adequacy | < 0.001 | ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 27.9 (23.6) | 46.2 (21.8) | 34.9 (24.4) | 22.5 (21.6) | |
median (range) | 30.0 (0.0-90.0) | 50.0 (0.0 - 80.0) | 40.0 (0.0 - 90.0) | 20.0 (0.0 - 70.0) | |
Sleep Somnolence | < 0.001 | ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 52.3 (26.0) | 27.6 (17.4) | 45.0 (24.0) | 58.8 (24.9) | |
median (range) | 53.3 (0.0-100.0) | 20.0 (6.7 - 80.0) | 40.0 (0.0 - 100.0) | 60.0 (0.0 - 100.0) | |
Snoring | 0.026 | ||||
n | 201 | 21 | 49 | 131 | |
mean (SD) | 43.3 (36.0) | 22.9 (26.3) | 46.1 (35.2) | 45.5 (36.8) | |
median (range) | 40.0 (0.0-100.0) | 20.0 (0.0 - 100.0) | 40.0 (0.0 - 100.0) | 40.0 (0.0 - 100.0) | |
Shortness of Breath or Headache | 0.001 | ||||
n | 202 | 21 | 49 | 132 | |
mean (SD) | 34.3 (30.8) | 14.3 (20.1) | 29.4 (30.3) | 39.2 (30.9) | |
median (range) | 40.0 (0.0-100.0) | 0.0 (0.0 - 60.0) | 20.0 (0.0 - 100.0) | 40.0 (0.0 - 100.0) | |
Sleep Quantity | 0.002 | ||||
n | 194 | 21 | 49 | 124 | |
mean (SD) | 6.3 (1.9) | 6.8 (1.1) | 6.8 (2.0) | 6.0 (1.9) | |
median (range) | 6.0 (1.0-12.0) | 7.0 (4.0 - 9.0) | 7.0 (1.0 - 11.0) | 6.0 (2.0 - 12.0) | |
MAF
| |||||
Global Fatigue Index | < 0.001 | ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 30.7 (14.2) | 16.5 (7.1) | 26.3 (12.6) | 34.6 (13.8) | |
median (range) | 35.8 (2.5-50.0) | 17.5 (2.5 - 27.2) | 29.6 (7.5 - 49.5) | 39.4 (7.5 - 50.0) | |
HADS
| |||||
Anxiety | < 0.001 | ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 10.2 (4.8) | 5.5 (3.6) | 7.3 (4.2) | 12.0 (4.1) | |
median (range) | 11.0 (0.0-12.0) | 4.0 (1.0 - 12.0) | 7.0 (0.0 - 16.0) | 12.0 (2.0 - 21.0) | |
Depression | < 0.001 | ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 9.4 (4.4) | 3.2 (2.7) | 7.2 (2.6) | 11.3 (3.8) | |
median (range) | 9.0 (0.0-21.0) | 2.0 (0.0 - 9.0) | 7.0 (1.0 - 12.0) | 11.0 (2.0 - 21.0) |
Cognitive Area | Overall (n = 203) | Mild (n = 21) | Moderate (n = 49) | Severe (n = 133) | p-valuea
|
---|---|---|---|---|---|
Concentrate, n (%) | < 0.001 | ||||
Not at all | 9 (4.4) | 4 (19.0) | 4 (8.2) | 1 (0.8) | |
A little | 41 (20.2) | 11 (52.4) | 15 (30.6) | 15 (11.3) | |
Moderately | 49 (24.1) | 4 (19.0) | 14 (28.6) | 31 (23.3) | |
Very much | 82 (40.4) | 2 (9.5) | 15 (30.6) | 65 (48.9) | |
Totally | 22 (10.8) | 0 (0.0) | 1 (2.0) | 21 (15.8) | |
Remember, n (%) | < 0.001 | ||||
Not at all | 11 (5.4) | 5 (23.8) | 4 (8.2) | 2 (1.5) | |
A little | 38 (18.7) | 10 (47.6) | 14 (28.6) | 14 (10.5) | |
Moderately | 43 (21.2) | 4 (19.0) | 9 (18.4) | 30 (22.6) | |
Very much | 89 (43.8) | 2 (9.5) | 21 (42.9) | 66 (49.6) | |
Totally | 22 (10.8) | 0 (0.0) | 1 (2.0) | 21 (15.8) | |
Make Decisions, n (%) | < 0.001 | ||||
Not at all | 24 (11.8) | 9 (42.9) | 4 (8.2) | 11 (8.3) | |
A little | 56 (27.6) | 9 (42.9) | 24 (49.0) | 23 (17.3) | |
Moderately | 51 (25.1) | 2 (9.5) | 13 (26.5) | 36 (27.1) | |
Very much | 63 (31.0) | 1 (4.8) | 8 (16.3) | 54 (40.6) | |
Totally | 9 (4.4) | 0 (0.0) | 0 (0.0) | 9 (6.8) | |
Think, n (%) | < 0.001 | ||||
Not at all | 19 (9.4) | 8 (38.1) | 7 (14.3) | 4 (3.0) | |
A little | 54 (26.6) | 9 (42.9) | 16 (32.7) | 29 (21.8) | |
Moderately | 53 (26.1) | 3 (14.3) | 14 (28.6) | 36 (27.1) | |
Very much | 64 (31.5) | 1 (4.8) | 12 (24.5) | 51 (38.3) | |
Totally | 13 (6.4) | 0 (0.0) | 0 (0.0) | 13 (9.8) |
Impact of FM on Productivity
Severity Level | |||||
---|---|---|---|---|---|
Overall
|
Mild
|
Moderate
|
Severe
|
p-value
a
| |
Days missed from work due to FMb
| 0.030 | ||||
n | 78 | 14 | 29 | 35 | |
mean (SD) | 1.8 (3.9) | 0.4 (0.9) | 1.0 (1.4) | 3.0 (5.4) | |
median (range) | 0.0 (0.0-28.0) | 0.0 (0.0-3.0) | 0.0 (0.0-4.0) | 1.0 (0.0-28.0) | |
Days worked with symptoms related to FMb
| < 0.001 | ||||
n | 81 | 15 | 30 | 36 | |
mean (SD) | 15.6 (9.0) | 6.9 (7.4) | 15.3 (7.7) | 19.4 (8.2) | |
median (range) | 17.0 (0.0-28.0) | 5.0 (0.0-28.0) | 17.0 (0.0-28.0) | 20.0 (0.0-28.0) | |
Average effectiveness at work on days with FM symptomsb
| 0.002 | ||||
n | 70 | 11 | 28 | 31 | |
mean (SD) | 75.3 (18.3) | 89.8 (11.0) | 77.7 (15.1) | 67.9 (19.7) | |
median (range) | 80.0 (20.0-100.0) | 90.0 (70.0-100.0) | 80.0 (30.0-100.0) | 75.0 (20.0-100.0) | |
Hours of unpaid caregiver help for FM in activities of daily living | 0.003 | ||||
n | 203 | 21 | 49 | 133 | |
mean (SD) | 29.1 (88.5) | 3.6 (7.0) | 22.8 (100.3) | 35.4 (90.4) | |
median (range) | 5.0 (0.0-720.0) | 0.0 (0.0 - 30.0) | 0.0 (0.0 - 700.0) | 8.0 (0.0 - 720.0) |