Rotator Cuff Related Shoulder Pain
Conditions
Keywords
blood flow restriction, exercise, rotator cuff-related shoulder pain
Brief summary
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.
Interventions
DEVICEResistance exercise with low AOP
Three 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.
DEVICEResistance exercise with moderate BFR
Three 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.
DEVICEResistance exercise with high BFR
Three 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.
DEVICEResistance exercise with sham BFR
Three 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.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * Suspected frozen shoulder (50% reduction or more than 30° loss in passive shoulder external rotation) * Primary diagnosis of shoulder instability or acromioclavicular pathology * Shoulder pain due to primary involvement in the cervical or thoracic region * Corticosteroid injections in the last 6 weeks * Presence of diseases such as inflammatory arthritis, neurological diseases, fibromyalgia, malignant tumors, or polymyalgia rheumatica * Presence of more than one risk factor for thromboembolism * Participation in upper limb exercise programs in the last month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity at rest (Visual Analogue Scale, 0-10) | Periprocedural | 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) | Periprocedural | 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
| Measure | Time frame | Description |
|---|---|---|
| Pressure pain threshold | Periprocedural | Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer |
| Exercise tolerance with each setting | Periprocedural | Exercise tolerance with each setting according to the following 5-point scale: well tolerated, tolerated, neutral, poorly tolerated, not tolerated. |
| Occurrence of adverse effects | Immediately after the intervention, 1 hour, 6 hours, 24 hours | 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 | Periprocedural | Surface electromyography for the study of muscle recruitment (middle deltoid, infraspinatus, teres minor and trapezius muscles) |
Countries
Spain
Contacts
CONTACTAdrian Escriche-Escuder, PhD
PRINCIPAL_INVESTIGATORAdrian Escriche-Escuder, PhD
University of Valencia
Outcome results
None listed