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 events	LIGHT (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 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 soreness	17 (37)	25 (56)	19 (−2 to 39)
Shoulder is locked	3 (4)	2 (4)	−2 (−11 to 7)
Subluxation	3 (7)	1 (2)	−4 (−12 to 4)
Dislocation	0 (0)	1 (2)	2 (−2 to 7)
Persistent worsening of symptoms	8 (17)	8 (18)	0 (−15 to 16)
Other sites than index shoulder
Headache	9 (20)	18 (40)	20 (2 to 39)
‘Other’ minor events related to index shoulder or other sites	18 (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 soreness	0 (0 to 1)	1 (0 to 2)	1 (−0.1 to 2.1)
Shoulder is locked	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Subluxation	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Dislocation	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Persistent worsening of symptoms	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Other sites than index shoulder
Headache	0 (0 to 0)	0 (0 to 1)	0 (0 to 0)
‘Other’ minor events related to index shoulder or other sites	0 (0 to 1)	0 (0 to 1)	0 (0 to 0)
	0 (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).