About this trial
This study aims to compare the effects of blood flow restricted (BFR) exercise and to examine the differences between various BFR protocols on acute pain reduction in individuals with rotator cuff-related shoulder pain, as well as the exercise tolerance at each intensity and occlusion setting. There are four exercise modalities corresponding to different combinations of intensity (%RM) and percentage of occlusion (%AOP): 1) 30% RM and 30% AOP; 2) 30% RM and 50% AOP; 3) 30% RM and 70% AOP; 4) 30% RM and BFR placebo (cuff without pressure).
All participants will complete one session of each of the four exercise modalities, analyzing the variables studied in each for subsequent analysis and comparison.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65
Shoulder symptoms lasting at least 3 months
Pain in the proximal anterolateral aspect of the shoulder, aggravated by abduction
At least two of the following tests positive: Jobe test, resisted external rotation test, Hawkins-Kennedy test, Neer test, painful arc between 60 and 120 degrees of shoulder abduction
Disqualifiers
History of shoulder trauma or surgery
Pain of such intensity that it is impossible to perform the proposed exercises
Active arm elevation less than 90 degrees
Clinical signs of a complete tear (positive delayed external and internal rotation sign and positive arm drop test)
Trial design
Crossover
Treatments tested in this trial
Resistance exercise with low AOP
DeviceThree exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a 30% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises.
Resistance exercise with moderate BFR
DeviceThree exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a 50% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises.
Resistance exercise with high BFR
DeviceThree exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a 70% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises.
Resistance exercise with sham BFR
DeviceThree exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a sham blood flow restriction application (cuff applied without pressure). 30" rest between sets, 2' rest between exercises.
Treatment groups
Trial outcomes
Primary outcomes
Pain intensity at rest (Visual Analogue Scale, 0-10)
Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.
Pain intensity during movement (Visual Analogue Scale, 0-10)
Pain intensity perceived on a Visual Analogue Scale during movement (flexion and abduction movement without load), being 0 no pain and 10 the worst pain imaginable
Secondary outcomes
Pressure pain threshold
Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer
Exercise tolerance with each setting
Exercise tolerance with each setting according to the following 5-point scale: well tolerated, tolerated, neutral, poorly tolerated, not tolerated.
Occurrence of adverse effects
Occurrence of adverse effects (e.g., pain, delayed onset muscle soreness, sudden weakness of the trained limb, redness or swelling of the trained limb, etc.) by self-report.
Surface electromyography
Surface electromyography for the study of muscle recruitment (middle deltoid, infraspinatus, teres minor and trapezius muscles)
Sponsors and contacts
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