About this trial
This study aims to analyze the effects of 4 weeks of low-intensity exercise with and without blood flow restriction (BFR) on pain, fear of movement, catastrophizing about pain, strength, and disability in a population with rotator cuff-related shoulder pain. There are two modalities corresponding to the same exercises under different blood flow restriction conditions: 1) 3 low-intensity exercises (30% 1RM) with BFR (50% AOP); 2) 3 low-intensity exercises (30% 1RM) without BFR.
Participants will be randomly assigned to one of two groups and will undergo a 4-week intervention. The variables of interest will be assessed in each group 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
Pain of an intensity that prevents performance of 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 drop arm test).
Suspected frozen shoulder (50% reduction or more than 30° loss of passive shoulder external rotation).
Trial design
Parallel
Treatments tested in this trial
Resistance exercise with 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 without BFR
Procedure/SurgeryThree 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 without flow restriction application (cuff applied without pressure). 30" rest between sets, 2' rest between exercises.
Treatment groups
Trial outcomes
Primary outcomes
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
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.
Pressure pain threshold
Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer.
Kinesiophobia
Assessment of fear of movement or reinjury, assessed via the self-administered Tampa Scale of Kinesiophobia questionnaire.
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.
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