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=50n=50
Primary outcome measure
 WOSI total (scale 0–2100)96/97802.6 (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)96/97346.5 (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)96/97150.7 (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)96/97134.5 (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)96/97169.3 (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 rating95/971.3 (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 rating95/974.0 (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 rating95/972.3 (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 rating95/971.3 (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 rating95/973.0 (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 rating95/971.9 (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)95/975.6 (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)95/9732.5 (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)94/9714.0 (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)94/9722.2 (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)94/970.76 (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)94/9769.6 (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 passive87/9072.6 (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 active87/9068.9 (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 passive87/90105.3 (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 active87/90100.6 (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)
  Scaption87/900.48 (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 rotation87/900.37 (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 rotation87/900.25 (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 range87/904.65 (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-range86/903.34 (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=yes87/9078 (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°87/9062 (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=yes87/9070 (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=yes87/9055 (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=yes87/9050 (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 2–387/9068 (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 2–387/9028 (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 cm87/9084 (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°87/9092 (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°87/9063 (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 Effect‡¶
  (% rated important effect postintervention)
  Physical symptoms45/4744 (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/work45/4738 (25 to 53)51 (37 to 65)OR 1.72 (0.75 to 3.94)OR 1.82 (0.82 to 4.03)
  Lifestyle45/4744 (31 to 59)55 (41 to 69)OR 1.55 (0.68 to 3.52)OR 1.60 (0.65 to 3.96)
  Emotions45/4740 (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.