Rotator Cuff Related Shoulder PainNCT07232511
Exercise-induced Hypoalgesia Effects of Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain
A study testing Resistance exercise with low AOP, Resistance exercise with moderate BFR and Resistance exercise with high BFR in people with Rotator Cuff Related Shoulder Pain, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Related Shoulder Pain
- What is being tested?
- Resistance exercise with low AOP, Resistance exercise with moderate BFR and Resistance exercise with high BFR
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 5 Mar 2026to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Physiotherapy, University of Valencia
Valencia, Valencia, 46010
Adrian Escriche-Escuder, 963983853, dep.fisioterapia@uv.es
About this study
Official title: Differences in Exercise-induced Hypoalgesia After a Session With Different Blood Flow Restriction Protocols in People With Rotator Cuff-related Shoulder Pain
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.
- Conditions
- Rotator Cuff Related Shoulder Pain
- Being tested
- Resistance exercise with low AOP, Resistance exercise with moderate BFR, Resistance exercise with high BFR, Resistance exercise with sham BFR
- Keywords
- blood flow restriction, exercise, rotator cuff-related shoulder pain
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise with low AOPDevice
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.
Resistance exercise with moderate BFRDevice
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.
Resistance exercise with high BFRDevice
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.
Resistance exercise with sham BFRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise with low blood occlusion | Experimental | A single session of exercise, 30% repetition maximum, and 30% blood occlusion Receives: Device: Resistance exercise with low AOP |
| Resistance exercise with moderate blood occlusion | Experimental | A single session of exercise, 30% repetition maximum, and 50% blood occlusion Receives: Device: Resistance exercise with moderate BFR |
| Resistance exercise with high blood occlusion | Experimental | A single session of exercise, 30% repetition maximum, and 70% blood occlusion Receives: Device: Resistance exercise with high BFR |
| Resistance exercise with sham blood flow restriction | Sham comparator | A single session of exercise, 30% repetition maximum, and without blood restriction (cuff applied without pressure) Receives: Device: Resistance exercise with sham BFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural
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
Measured: Periprocedural
Secondary outcomes (4)
Pressure pain threshold
Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer
Measured: Periprocedural
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.
Measured: Periprocedural
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.
Measured: Immediately after the intervention, 1 hour, 6 hours, 24 hours
Surface electromyography
Surface electromyography for the study of muscle recruitment (middle deltoid, infraspinatus, teres minor and trapezius muscles)
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start5 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Related Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrián Escriche Escuder, University of Valencia
- Investigators
- Adrian Escriche-Escuder, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232511
- Sponsor's protocol ID
- 2025-FIS-3945738
- Status last verified
- Apr 2026
- First submitted
- 26 Sep 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study will be available from the corresponding author upon reasonable request.