Table 3

Adverse events (specific, serious or minor, and withdrawals due to adverse events), and crude difference between risks and medians were calculated with 95% CIs based on the ‘as observed’ data while still respecting the original group allocation, from baseline to 16-week follow-up for the intervention (HEAVY) versus comparator (LIGHT) in patients with hypermobility spectrum disorder and shoulder symptoms

Adverse eventsLIGHT (n=46)HEAVY (n=45)Between-group risk difference or median difference with 95% CI (crude)*
Number of patients reporting serious adverse events†0 (0)0 (0)0 (0 to 0)
Number of patients reporting minor adverse events (n (%))24 (52)29 (64)12 (−8 to 32)
 Index shoulder
  Muscle soreness17 (37)25 (56)19 (−2 to 39)
  Shoulder is locked3 (4)2 (4)−2 (−11 to 7)
  Subluxation3 (7)1 (2)−4 (−12 to 4)
  Dislocation0 (0)1 (2)2 (−2 to 7)
  Persistent worsening of symptoms8 (17)8 (18)0 (−15 to 16)
 Other sites than index shoulder
  Headache9 (20)18 (40) 20 (2 to 39)
 ‘Other’ minor events related to index shoulder or other sites18 (39)19 (42)3 (−17 to 23)
Total number of adverse events
 Number of minor adverse events (median (95% CI)‡1 (0 to 1.1)2 (0.4 to 4.0)1 (−0.6 to 2.6)
 Index shoulder
  Muscle soreness0 (0 to 1)1 (0 to 2)1 (−0.1 to 2.1)
  Shoulder is locked0 (0 to 0)0 (0 to 0)0 (0 to 0)
  Subluxation0 (0 to 0)0 (0 to 0)0 (0 to 0)
  Dislocation0 (0 to 0)0 (0 to 0)0 (0 to 0)
  Persistent worsening of symptoms0 (0 to 0)0 (0 to 0)0 (0 to 0)
 Other sites than index shoulder
  Headache0 (0 to 0)0 (0 to 1)0 (0 to 0)
 ‘Other’ minor events related to index shoulder or other sites0 (0 to 1)0 (0 to 1)0 (0 to 0)
Number of dropouts due to adverse events (n, (%))0 (0)2 (4)§4 (−2 to 10)
  • This table includes all adverse events that occurred during the 16-week study period, but which did not necessarily have a causal relationship with the treatment administered.

  • Statistically significant results (p<0.05) are marked with bold.

  • *The adjusted (age, sex, clustering around clinic) risk difference using margins after fitting a logistic regression model did not change the estimates (online supplemental file 6).

  • †Serious adverse events were unexpected but covered death, life-threatening events, disability and permanent damage.

  • ‡For each patient, each adverse event could count 0–16 times corresponding with 16 weeks intervention period.

  • §One dropout due to worsening of symptoms caused by lack of supervision during COVID-19 pandemic, and one patient had suffered from a hand fracture not related to the intervention (data not included in table 3).