Exercise-induced Hypoalgesia Effects of Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resistance exercise with low AOP, Resistance exercise with moderate BFR, Resistance exercise with high BFR, Resistance exercise with sham BFR.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Related Shoulder Pain. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Differences in Exercise-induced Hypoalgesia After a Session With Different Blood Flow Restriction Protocols in People With Rotator Cuff-related Shoulder Pain
Overview
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
- Device Resistance 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. - Device Resistance 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. - Device Resistance 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. - Device Resistance 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.
Primary outcome measures
- Pain intensity at rest (Visual Analogue Scale, 0-10) [Time frame: Periprocedural]
- Pain intensity during movement (Visual Analogue Scale, 0-10) [Time frame: Periprocedural]
Secondary outcome measures (4)
- Pressure pain threshold [Time frame: Periprocedural]
- Exercise tolerance with each setting [Time frame: Periprocedural]
- Occurrence of adverse effects [Time frame: Immediately after the intervention, 1 hour, 6 hours, 24 hours]
- Surface electromyography [Time frame: Periprocedural]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Faculty of Physiotherapy, University of Valencia — Valencia
Identifiers
NCT: NCT07232511 · 2025-FIS-3945738