About this trial
The aim of this study is to evaluate the efficacy of 12 weeks of sensorimotor training with movement representation techniques for reducing pain intensity in people with rotator cuff related shoulder pain, relative to standard care. Besides, the secondary aim of this study is to explore the mechanisms underlying the effects of central mechanism treatment in people with rotator cuff related shoulder pain. A total of 122 older adults aged 50 or above with the presence of shoulder pain for more than three months will be recruited and randomized into 12-weeks of movement representation techniques with sensorimotor training vs. standard care. Shoulder pain and disability Index (SPADI), changes in primary motor cortex (M1) using brain MRI, changes in subacromial space using ultrasound imaging, Widespread Pain Index (WPI), Pain Catastrophising Scale (PCS), and Fear-avoidance Beliefs questionnaires (FABQ) will be assessed at baseline and 12-week post intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 50 or above
Presence of shoulder pain for more than three months
Clinical test showed 3/5 positive tests (painful arc, resisted external rotation, Neer test, Kennedy-Hawkins test, and Jobe test), and the intensity of pain being provoked should be ≥ 3/10 on an 11-point numeric pain rating scale (NPRS)
Structural changes of rotator cuff tendons using MRI or ultrasound imaging
Disqualifiers
History of trauma
Shoulder fracture, glenohumeral osteoarthritis, or arthritis in the acromioclavicular joint
Clinically suspected labrum lesion
Previous shoulder surgery or dislocation
Trial design
Parallel
Treatments tested in this trial
Sensorimotor training with movement representation techniques
Other interventionSensorimotor training will be implemented with movement representation techniques using a standardized retraining sequence of a shoulder control exercise during arm elevation with 3 phases: Phase 1: Action Observation Training; Phase 2: Mirror therapy; and Phase 3: Sensorimotor training of the involved arm. Each session will last 60 minutes, with one supervised intervention session over the 12 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Pain intensity
Pain will be assessed using the pain sub-score of the Chinese Version of the Shoulder Pain and Disability Index. It is a validated self-administered questionnaire used to evaluate upper limb symptoms and functional limitations during daily activities. The questionnaire consists of 13 items with two subscales, i.e., pain intensity (five items) and disability (eight items), and each subscale-item will be summed to obtain a pain-score and a disability-score. The total of all items will be summed to obtain the final scores for each domain ranging from 0 to 100, with higher scores indicating more pain and disability. In the present study, the pain sub-score will be used as the measure of average pain intensity.
Secondary outcomes
Cortical thickness in the primary motor cortex (M1) using brain MRI
The brain structure will be measured using structural and resting-state functional magnetic resonance imaging (fMRI) on a 3.0 T Siemens Prisma scanner. During the resting-state scan, the participants will be instructed to rest with their eyes closed while remaining stationary for 30 minutes. The regional cortical thickness of the brain region, the primary motor cortex (M1), will be extracted from T1-weighted MRI images.
Other outcomes
Shoulder strength
The isokinetic testing of shoulder rotational strength will be measured using a Cybex Norm isokinetic dynamometer
Subacromial space
The subacromial space will be scanned using an ultrasound scanning system during arm resting at 0° and static arm holding at 60° of shoulder abduction. The subacromial space will be measured from the tangential distance between the humeral head and the infero-lateral edge of the acromion. Three measurements will be recorded and the averaged value will be calculated.
Central pain processing
The Widespread Pain Index will be adopted to capture features of central sensitisation. It quantifies the extent of bodily pain on a 0-19 scale, assessing whether patients have pain in 19 different body regions, each point scores 1. All items will be summed to obtain a final score ranging from 0 to 100, with higher scores indicating more widespread pain.
Pain Catastrophising
The Chinese version of the Pain Catastrophising Scale will be used to assess pain catastrophising. This is a validated self-administered questionnaire consisting of 13-items examining pain-related behaviours and cognition. Scores range from 0 to 52, with higher scores indicating a higher level of catastrophising.
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