None listed
Conditions
Brief summary
A recent Australia-wide survey found that many general practitioners recommend unnecessary imaging and surgical referrals for a common type of shoulder pain (rotator cuff tendinopathy). We hypothesise that educating patients with rotator cuff tendinopathy directly about their condition and recommended care has the potential to reduce nappropriate imaging and surgery, increase adherence to recommended care and ultimately improve healthcare outcomes. The proposed study is a three-arm, parallel group, pilot and feasibility randomised controlled trial. Participants will be randomised to one of three trial arms; Group (i) standard advice and exercise via online pamphlet; group (ii) pamphlet in (i) + video delivery; group (iii) pamphlet in (i) & videos in (ii) and individualised daily feedback.
Interventions
(i) standard advice and exercise via online pamphlet; (ii) pamphlet in (i) + video delivery; (iii) pamphlet in (i) & videos in (ii) and individualised daily feedback. Participants will enter their pain and fatigue following each set of exercise and will receive individualised feedback about whether they should progress or regress exercise based on this. Education will be identical in all groups, only the delivery mode will differ. The education pamphlet and information has been custom designed for this study. Education will include the causes, pain mechanisms, exercise treatments and their efficacy and mechanisms, and other treatments and their efficacy. Emphasis will be placed on addressing knowledge gaps and barriers and enablers to recommended care. For example, challenging participants’ understanding of the relevance of tendon structure and imaging, expectations from exercise interventions, and pain and exercise self-efficacy. In each group participants will have free access to the pamphlet (group 1), pamphlet and videos (group 2/3) to watch as many times as they desire we advise that they watch the videos at least 1-2 times to comprehend the advice and instructions). The pamphlet is A4 pages and there is a series of <6 minute videos totally 20-30 minutes. The inidvidualised daily feedback in group 3 is provided via an online computer algorithm in response to the level of pain and fatigue the participants reports after each set of exercise. Exercise intervention: This will be identical for all groups, only the delivery mode will differ. The intervention will include shoulder elevation (from 10-150 degrees because extremes are usually provocative) and external rotation (full range). Elevation can be performed into shoulder abduction, scaption or flexion, depending on acceptable pain response (pain that is 'minimal' or less than 5/10 with activity and any increase in pain after exercise settles to pre-exercise levels relatively quickly ie within 12-24 hours). If pain during exercise is beyond 5/10 participants are advised to reduce weight, repetitions or range of motion until pain response is acceptable, or revert to isometric hold exercise until pain with through range exercise is acceptable. Exercise will be performed once per day over 12 weeks (3 sets of 15 repetitions and 4 seconds per cycle for isotonic exercise [2 second concentric and 2 second eccentric phase] or 6 sets of 30 seconds if isometric exercise is commenced initially). Exercise progression will be based on 1) achieving the prescribed dosage (sets, repetitions, time under tension) if this is not possible initially due to pain response or fatigue; 2) Then progressing load using a hand-held weight (elevation) or a theraband (external rotation) so that fatigue is achieved after 14-16 repetitions (otherwise they will be encouraged to use a heavier or lighter weight or theraband). Participants will be provided with education about how to progress and regress exercise based on acceptable pain response. Particioants will be advised to increase exercise exetrnal load if pain during exercise is acceptable and muscular fatigue is not experienced after the allocated repetitions. Regression (reduced load) will occur if pain is beyond what has been defined as acceptable. If the participant is not using a weight they regression will involve reducing the repetitions or range of motion, or reverting to an isometric hold exercise. The exercise and education components have been designed by board certified physiotherapists based on expert consensus and available evidence. They will be delivered completely remotely, without any clinician input or guidance.
Sponsors
Study design
Eligibility
Inclusion criteria
Participants will be included if they are over the age of 18 and answer apporopriately (indicated in brackets) to the following screening questions; (i) is your shoulder pain MAINLY around the areas shown in the photos below [anterolateral shoulder/upper arm) (YES); (ii) is your shoulder pain made worse by neck movement (NO); (iii) Is the shoulder pain made worse by moving your arm above your head (YES); (ix) Are you able to lift you arm to the height indicated in the photo (90 degrees flexion) (YES)
Exclusion criteria
Exclusion criteria: Participants will be excluded if they answer yes to the following questions (i) Have you had a recent trauma involving the shoulder such as a fall?; (ii) Do you have swelling and pain in multiple joints?; (iii) Have you ever had a fever associated with your shoulder pain?; (iv) Have you had recent unexplained weight loss?; (v) Do you have constant pins and needles or numbness in ANY of your hands, feet, or groin region?; (vi) Do you have bowel / bladder problems, such as weakness or retention?; (vii) Have you had a sudden change in your bowel habits, such as severe constipation?; (viii) Are you unable to move your arm at all due to pain?. (ix) I am severely depressed; (x) I am taking recreational drugs; (xi) I am taking/have taken corticosteroids; (xii) I have/have had angina or heart problems; (xiii) since my shoulder problem started I have had a sudden onset of severe, steady and worsening abdominal and upper back pain; (xiv) I have had cancer at some time in the past; (xv) I am on Warfarin or another 'blood thinner'; (xvi) I have recently had ANY OF dizziness, blurred vision, slurred speech, difficulty swallowing, falls or unsteadiness; (xvii) I have recently had seizures.