Publication: The Ad-Shoulder Feasibility Study
In order to improve adherence to exercises in patients with persistent subacromial pain, we developed a personalised supported self-management intervention (the Ad-Shoulder intervention). Before commencing a main randomised controlled trial (RCT) it is recommended to run a feasibility study.
The primary objectives were assessed according to predefined progression criteria: (1) the recruitment rate (10 patients enrolled within 12 weeks), (2) follow-up rate (≥ 80% on all self-reported measures), (3) objective physical activity measures (≥ 80% of participants would contribute valid data at each time point), (4) adherence with the self-managed exercises (≥ 80% of the participants would adhere to ≥ 80% of the assigned home exercise programme), (5) fidelity of the delivery of the intervention (the therapists delivered the intervention according to the protocol) and (6) adverse events (< 30% would report adverse events (including mild)).
Eleven patients were recruited during 16 weeks. Ten patients completed the self-reported measures at baseline and week 12. Objective physical activity measures were successfully obtained for 100% (11/11) at baseline, 64% (7/11) at week six and 82% at week 12. Fifty-five percent (6/11) of the participants satisfactorily completed at least 80% of their home exercise programme. All sessions were delivered according to the protocol. None of the patients reported any adverse events.
Objective physical activity data measures at baseline and week 12, follow-up, the physiotherapists’ fidelity to the intervention and adverse events met our pre-specified progression criteria. Recruitment and adherence to the self-managed exercise programme were both below the anticipated level. Further intervention development is necessary to understand whether adherence to the self-managed exercises could be enhanced and additional methods of recruitment would need to be considered, including additional recruitment sites, in any planning for a future main trial.
Authors: Daniel H. Major, Margreth Grotle, Chris Littlewood, Jens Ivar Brox, Dagfinn Matre, Heidi V. Gallet, Yngve Røe
Link to the full-text (open access) published in Pilot and Feasibility studies 25.01.21: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00767-6?fbclid=IwAR0kSw6eFutHyRfv9NsLVl71y6Hha3JJ0Tf0Kp-_akL5cnB2EcescS4nb7M#citeas