Methods
ache, disability, pain
REGRESSION, RECRUITMENT
The ARM trial protocol was registered (reference: ISRCTN79085082) [Participants were examined according to the Southampton examination protocol [Randomization was online (with telephone backup) allowing immediate allocation to a group, using a mixed randomization and minimization algorithm. This enabled balanced recruitment by recruitment site; site of symptoms (dominant, non-dominant or bilateral); hand/wrist versus elbow; and functional capacity defined by the modified Disabilities of the Arm, Shoulder and Hand (mDASH) score [The three trial groups were allocated to waiting-list physiotherapy plus a novel leaflet ‘Arm pain. How to deal with it - keep active to recover quickly’ [The principal outcome measure was the reduction of disability as measured by the validated mDASH, which asks participants to report difficulties caused by an ‘ache or pain in the elbow, forearm, wrist or hand’ in the past 7 days, with any of a list of 11 separate activities (Options: yes, no, not applicable). The mDASH was assessed at baseline and by postal follow-up at 6-, 13- and 26-week post-randomization. Non-responders were telephoned to obtain verbal responses. Secondary outcomes were days of sickness absence at 6, 13 and 26 weeks; left job due to arm pain at 6, 13 and 26 weeks.A mixed-effects logistic regression model was used to model the probability of achieving full recovery (mDASH = 0) and to estimate the difference in probability (rather than the odds ratios) between groups. The model included treatment group (as a three-level categorical variable), age, gender, study centre, pain location (elbow, wrist/hand or both), laterality (dominant, non-dominant or bilateral) and baseline function (mDASH: 0–5, 6–8 or 9–11). The rates of achievement of the primary outcome were compared firstly amongst working participants who received advice to remain active, as compared with those advised to rest. Subsequently, the effects of early physiotherapy versus physiotherapy after the usual waiting time were compared.To explore whether there were differential responses by nature and/or type of work to the treatment received, a series of mixed-effects logistic models were constructed to estimate the probability of full recovery (mDASH = 0) at 26 weeks, with each model including treatment group, age, gender, pain location, laterality and baseline function. A separate model was constructed for manual versus non-manual work; keyboard use >4 hours/day; repetitive use of the fingers/wrist >1 hour/day; repetitive movements of the elbow >1 hour/day; vibration of the hand/arms; lifting/carrying weights >10 kg).The trial was approved by the UK South Central (Hampshire A) Research Ethics Committee (reference: 11/SC/0107).