Table 1.
Key characteristics | Overall | US-guided injection plus physiotherapist-led exercise | US-guided injection plus leaflet | Unguided injection plus physiotherapist-led exercise | Unguided injection plus leaflet |
n=256 | n=64 | n=64 | n=64 | n=64 | |
Non-clinical characteristics | |||||
Age, mean (SD) | 53.8 (10.2) | 55.6 (10.5) | 54.8 (10.0) | 51.9 (10.7) | 53.0 (9.5) |
Females, n (%) | 133 (52.0) | 37 (57.8) | 29 (45.3) | 45 (70.3) | 22 (34.4) |
Previous or current smokers, n (%) | 139 (54.3) | 29 (45.3) | 38 (59.4) | 36 (56.3) | 36 (56.3) |
Right handed, n (%) | 217 (84.8) | 59 (92.2) | 52 (81.3) | 51 (79.7) | 55 (85.9) |
Currently in paid job, n (%) | 141 (55.1) | 31 (48.4) | 35 (54.5) | 34 (53.1) | 41 (64.1) |
Time off work in past 12 months because of shoulder problem, n (%) | 44 (29.3) | 10 (28.6) | 13 (36.1) | 8 (22.9) | 13 (29.6) |
Shoulder pain interference with work (NRS scale; 0–10) mean (SD) | 4.8 (2.9) | 4.6 (3.0) | 5.2 (2.8) | 4.2 (3.0) | 4.9 (2.9) |
Live alone, n (%) | 39 (15.4) | 10 (15.9) | 12 (18.8) | 7 (11.1) | 10 (15.9) |
Clinical characteristics | |||||
SPADI,* mean (SD) | |||||
Pain subscale score | 70.6 (15.5) | 69.1 (17.3) | 72.9 (14.8) | 70.9 (15.6) | 69.4 (15.5) |
Disability subscale score | 55.1 (21.5) | 54.3 (22.4) | 57.3 (21.1) | 57.1 (19.3) | 51.6 (22.9) |
Total SPADI score | 61.1 (18.1) | 60.0 (19.2) | 63.4 (17.6) | 62.4 (16.5) | 58.4 (18.9) |
Pain severity today (NRS scale; 0–10), mean (SD) | 5.7 (2.0) | 5.6 (2.1) | 5.9 (2.0) | 5.4 (1.9) | 5.8 (2.0) |
Both shoulders affected, n (%) | 20 (7.8) | 7 (10.9) | 3 (4.7) | 5 (7.8) | 5 (7.8) |
Duration of shoulder pain, n (%) | |||||
<3 months | 28 (10.9) | 6 (9.4) | 5 (7.8) | 8 (12.5) | 9 (14.0) |
3–6 months | 50 (19.5) | 16 (25.0) | 13 (20.3) | 9 (14.0) | 12 (18.8) |
6–12 months | 74 (28.9) | 17 (26.6) | 18 (28.1) | 26 (40.6) | 13 (20.3) |
>12 months | 104 (40.6) | 25 (39.1) | 28 (43.8) | 21 (32.8) | 30 (46.9) |
Previous episode of shoulder pain, n (%) | 87 (34.0) | 16 (25.0) | 24 (37.5) | 17 (26.6) | 30 (46.9) |
Troubled by shoulder pain in bed most or every night, n (%) | 205 (80.1) | 48 (75.0) | 51 (79.7) | 51 (79.7) | 55 (85.9) |
Pain self-efficacy scale,† mean (SD) | 35.6 (15.3) | 35.2 (15.3) | 35.4 (13.7) | 34.9 (14.0) | 36.7 (10.8) |
Fear of movement,‡ mean (SD) | 27.0 (5.1) | 28.0 (5.4) | 27.2 (4.8) | 26.4 (4.6) | 26.4 (5.4) |
SF-12-PCS§, mean (SD) | 38.1 (9.7) | 37.3 (8.9) | 38.5 (9.5) | 38.1 (10.9) | 38.5 (9.8) |
SF-12-MCS¶, mean (SD) | 47.2 (12.6) | 47.9 (12.7) | 46.8 (13.3) | 45.8 (12.4) | 48.1 (12.2) |
Other health conditions,** n (%) | 137 (53.5) | 38 (59.4) | 32 (50.0) | 37 (57.8) | 30 (46.9) |
Widespread pain, n (%) | 62 (24.8) | 15 (23.8) | 19 (30.7) | 17 (26.6) | 11 (18.0) |
BMI categories, n (%) | |||||
Normal/underweight | 74 (29.5) | 17 (26.6) | 17 (26.6) | 22 (36.1) | 18 (29.0) |
Overweight | 62 (24.7) | 22 (34.4) | 13 (20.3) | 12 (19.7) | 15 (24.2) |
Obese/morbidly obese | 115 (45.8) | 25 (39.1) | 34 (53.1) | 27 (44.3) | 29 (46.8) |
*Shoulder Pain and Disability Index=Primary outcome measure (each scale/subscale ranges from 0 to 100; 0=no pain/difficulty, 100=worst pain/so difficult it required help).
†10 item scale, score range=0–60 (0=not at all confident, 60=completely confident).
‡Assessed using Tampa scale for kinesiophobia-11– score range from 11 to 44 with higher scores reflecting greater fear of movement or (re)injury.
§SF PCS.
¶SF MCS (scales based on ‘Normalised’ general population average of 50 with SD 10).
**Health conditions include chest problems, heart problems, deafness, problems with eyesight (excluding need for glasses), raised blood pressure, diabetes, stroke, cancer, liver disease, kidney disease and circulation problems in the legs.
BMI, body mass index; MCS, Mental Component Scale; NRS, Numeric Rating Scale; PCS, Physical Component Scale; SF-12, Short Form-12; SPADI, Shoulder Pain and Disability Index; US, ultrasound.