Table 1.

Definitions of a proposed preliminary core domain set for trials of people with shoulder disorders.

Inner core
  PainHow much a person’s shoulder hurts, reflecting the overall magnitude of the pain experience (i.e., at rest, during and after activity, at night)
  Physical function/activityA person’s ability to carry out daily physical activities required to meet basic needs, ranging from self-care (e.g., bathing, combing hair) to more complex activities that require a combination of skills (e.g., driving a car)
  Global perceived effectA person’s assessment of their recovery or degree of improvement
  Adverse eventsAny major or minor adverse event that occurs during the course of the trial, including any deaths
Middle core
  Participation (recreation/work)A person’s ability to engage in any form of play, recreational, or leisure activity acts (e.g., sports of any kind or levels), and the ability to meet physical and/or psychological demands of work (for people who work)
  SleepSleep functions such as onset, maintenance, quality, amount of sleep, and functions involving the sleep cycle. This domain also includes the effect on perceptions of alertness and sleepiness during usual waking hours
  Emotional well-beingEffect on a person’s emotions, including levels of depression, anxiety, or other types of psychological distress. Depression refers to negative mood, loss of self-confidence, loss of motivation, and enjoyment. Anxiety refers to fear, extreme worrying, and hyper-arousal symptoms