Table 2.
Outcomes at 16-week follow-up for the intervention (HEAVY) and comparator (LIGHT) in patients with hypermobility spectrum disorder and shoulder complaints
| Total no. of assessments (LIGHT/HEAVY)* |
Mean at 16 weeks in LIGHT (95% CI) | Mean at 16 weeks in HEAVY (95% CI) | Between-group difference at 16 weeks (crude) (95% CI) | Between-group difference at 16 weeks (adjusted)† (95% CI) | |
| n=50 | n=50 | ||||
| Primary outcome measure | |||||
| WOSI total (scale 0–2100) | 96/97 | 802.6 (683.9 to 921.3) | 606.9 (481.1 to 732.7) | −195.7 (−367.7 to -23.7) | −174.5 (−341.4 to -7.7) |
| Secondary self-reported outcomes | |||||
| WOSI physical symptoms (scale 0–1000) | 96/97 | 346.5 (286.9 to 406.2) | 279.0 (222.4 to 335.6) | −67.5 (−149.3 to 14.3) | −68.6 (−144.7 to 7.4) |
| WOSI sports/recreation/work (scale 0–400) | 96/97 | 150.7 (121.6 to 179.9) | 111.8 (82.4 to 141.2) | −38.9 (−79.4 to 1.6) | −30.7 (−70.6 to 9.2) |
| WOSI lifestyle (scale 0–400) | 96/97 | 134.5 (108.3 to 160.8) | 96.6 (70.1 to 123.0) | −38.0 (−74.8 to -1.1) | −31.2 (−63.1 to 0.8) |
| WOSI emotions (scale 0–300) | 96/97 | 169.3 (147.9 to 190.8) | 121.7 (98.8 to 144.6) | −47.6 (−78.9 to -16.4) | −43.5 (−72.0 to -14.9) |
| Shoulder pain last 7 days (scale 0–10) | |||||
| Lowest rating | 95/97 | 1.3 (0.7 to 1.9) | 1.1 (0.6 to 1.6) | −0.2 (−1.0 to 0.5) | −0.3 (−1.0 to 0.4) |
| Highest rating | 95/97 | 4.0 (3.2 to 4.8) | 2.8 (2.1 to 3.5) | −1.2 (−2.2 to -0.1) | −1.0 (−2.0 to 0.1) |
| Average rating | 95/97 | 2.3 (1.6 to 2.9) | 1.7 (1.1 to 2.3) | −0.6 (−1.4 to 0.3) | −0.5 (−1.5 to 0.5) |
| Discomfort due to shoulder symptoms other than pain last 7 days (scale 0–10) | |||||
| Lowest rating | 95/97 | 1.3 (0.8 to 1.7) | 1.1 (0.6 to 1.6) | −0.1 (−0.8 to 0.5) | −0.2 (−0.9 to 0.5) |
| Highest rating | 95/97 | 3.0 (2.3 to 3.7) | 2.2 (1.6 to 2.8) | −0.8 (−1.7 to 0.1) | −0.6 (−1.2 to 0.1) |
| Average rating | 95/97 | 1.9 (1.4 to 2.5) | 1.5 (1.0 to 2.1) | −0.4 (−1.1 to 0.3) | −0.2 (−0.9 to 0.4) |
| Patient-Specific Functional Scale (scale 0–10) | 95/97 | 5.6 (4.8 to 6.3) | 5.7 (5.0 to 6.5) | 0.2 (−0.9 to 1.3) | 0.2 (−1.0 to 1.4) |
| Checklist Individual Strength (scale 8–56) | 95/97 | 32.5 (28.7 to 36.3) | 29.8 (26.4 to 33.1) | −2.7 (−7.7 to 2.3) | −2.5 (−7.1 to 2.2) |
| COOP/WONCA (scale 6–30) | 94/97 | 14.0 (12.7 to 15.3) | 12.9 (11.6 to 14.1) | −1.2 (−3.0 to 0.6) | −0.5 (−2.2 to 1.2) |
| Tampa Scale of Kinesiophobia (scale 11–44) | 94/97 | 22.2 (20.4 to 24.1) | 20.5 (18.8 to 22.1) | −1.8 (−4.2 to 0.7) | −0.8 (−2.7 to 1.1) |
| EQ-5D-5L (scale <0–1) | 94/97 | 0.76 (0.72 to 0.79) | 0.80 (0.76 to 0.83) | 0.04 (−0.01 to 0.09) | 0.02 (−0.02 to 0.07) |
| EQ-VAS (scale 0–100) | 94/97 | 69.6 (64.0 to 75.2) | 75.3 (70.6 to 80.1) | 5.7 (−1.5 to 13.0) | 0.3 (−8.0 to 8.6) |
| Secondary objective outcomes | |||||
| Range of motion (°) | |||||
| Internal rotation passive | 87/90 | 72.6 (67.3 to 78.0) | 69.9 (64.7 to 75.2) | −2.70 (−10.6 to 5.2) | −0.6 (−11.3 to 10.2) |
| Internal rotation active | 87/90 | 68.9 (64.1 to 73.7) | 71.2 (66.8 to 75.7) | 2.4 (−4.5 to 9.2) | 4.0 (−4.2 to 12.2) |
| External rotation passive | 87/90 | 105.3 (96.9 to 113.7) | 107.6 (100.0 to 115.1) | 2.2 (−9.8 to 14.3) | −0.5 (−16.4 to 15.4) |
| External rotation active | 87/90 | 100.6 (93.2 to 108.1) | 107.0 (100.5 to 113.6) | 6.4 (−4.2 to 17.0) | 3.4 (−10.8 to 17.5) |
| Isometric shoulder torque strength (Nm/kg) | |||||
| Scaption | 87/90 | 0.48 (0.42 to 0.54) | 0.52 (0.45 to 0.59) | 0.04 (−0.05 to 0.14) | 0.05 (−0.04 to 0.13) |
| Internal rotation | 87/90 | 0.37 (0.32 to 0.42) | 0.36 (0.30 to 0.41) | −0.01 (−0.09 to 0.06) | 0.00 (−0.07 to 0.07) |
| External rotation | 87/90 | 0.25 (0.22 to 0.28) | 0.27 (.23 to 0.31) | 0.02 (−0.03 to 0.07) | 0.03 (−0.03 to 0.08) |
| Proprioception in flexion (error °) | |||||
| Low range | 87/90 | 4.65 (3.71 to 5.60) | 4.98 (3.85 to 6.11) | 0.33 (−1.24 to 1.90) | 0.65 (−1.60 to 2.90) |
| Mid-range | 86/90 | 3.34 (2.65 to 4.04) | 4.51 (3.47 to 5.54) | 1.17 (0.01 to 2.32) | 1.17 (−0.27. 2.60) |
| Shoulder instability and laxity tests (positive %)‡ | |||||
| Shoulder flexion test, positive=yes | 87/90 | 78 (64 to 91) | 62 (47 to 76) | OR 0.46 (0.17 to 1.21) | OR 0.40 (0.09 to 1.75) |
| Shoulder rotation test, positive >180° | 87/90 | 62 (47 to 76) | 42 (28 to 56) | OR 0.44 (0.19 to 1.03) | OR 0.32 (0.13 to 0.80) |
| Apprehension test, positive=yes | 87/90 | 70 (55 to 85) | 62 (48 to 76) | OR 0.70 (0.29 to 1.65) | OR 0.59 (0.31 to 1.13) |
| Relocation test,§ positive=yes | 87/90 | 55 (38 to 72) | 44 (30 to 58) | OR 0.66 (0.28 to 1.56) | OR 0.59 (0.33 to 1.08) |
| Release test,§ positive=yes | 87/90 | 50 (32 to 68) | 37 (23 to 51) | OR 0.58 (0.24 to 1.39) | OR 0.58 (0.25 to 1.35) |
| Load and shift anterior, positive 2–3 | 87/90 | 68 (52 to 84) | 62 (47 to 77) | OR 0.77 (0.31 to 1.90) | OR 0.56 (0.23 to 1.40) |
| Load and shift posterior, positive 2–3 | 87/90 | 28 (13 to 44) | 18 (7 to 29) | OR 0.57 (0.20 to 1.61) | OR 0.63 (0.19 to 2.04) |
| Sulcus sign, positive >1 cm | 87/90 | 84 (68 to 93) | 85 (70 to 93) | OR 0.97 (0.28 to 3.34) | OR 1.05 (0.28 to 3.94) |
| Gagey, positive >105° | 87/90 | 92 (85 to 100) | 90 (78 to 100) | OR 0.73 (0.15 to 3.43) | OR 0.43 (0.14 to 1.37) |
| Rotés Queról, positive >90° | 87/90 | 63 (48 to 77) | 55 (41 to 69) | OR 0.73 (0.31 to 1.72) | OR 0.72 (0.20 to 2.66) |
| Global Perceived Effectঠ| |||||
| (% rated important effect postintervention) | |||||
| Physical symptoms | 45/47 | 44 (31 to 59) | 64 (49 to 76) | OR 2.21 (0.96 to 5.09) | OR 2.37 (1.07 to 5.24) |
| Sports/recreation/work | 45/47 | 38 (25 to 53) | 51 (37 to 65) | OR 1.72 (0.75 to 3.94) | OR 1.82 (0.82 to 4.03) |
| Lifestyle | 45/47 | 44 (31 to 59) | 55 (41 to 69) | OR 1.55 (0.68 to 3.52) | OR 1.60 (0.65 to 3.96) |
| Emotions | 45/47 | 40 (27 to 55) | 51 (37 to 65) | OR 1.57 (0.69 to 3.58) | OR 1.57 (0.51 to 4.85) |
Statistically significant results (p<0.05) are marked with bold.
*There were 100 possible assessments for each group (50 at baseline and 50 at 16 weeks follow-up), except for Global Perceived Effect which had 50 possible assessments for each group.
†The results are adjusted for baseline score, age, sex and the clustering around physiotherapy clinic.
‡Proportions of positive test in % (95% CI) and OR for between-group differences with group LIGHT as reference.
§Relocation and release tests were only performed on patients with a positive apprehension test.
¶No data imputation.
COOP/WONCA, Dartmouth Primary Care Cooperative Research Network/World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians; EQ-5D-5L, European Quality of life-5 Dimensions-5-Level; VAS, visual analogue scale; WOSI, Western Ontario Shoulder Instability Index.