Rotator Cuff Related Shoulder PainNCT07324993
Effects of a 4-week Low-intensity Training With Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain
A study testing Resistance exercise with BFR and Resistance exercise without BFR in people with Rotator Cuff Related Shoulder Pain, run by University of Valencia.
Trial summary
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. 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 BFR and Resistance exercise without BFR
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2028
- 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
- 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).
- Primary diagnosis of shoulder instability or acromioclavicular pathology.
- Shoulder pain due to primary involvement in the cervical or thoracic region
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- Corticosteroid injection within the last 6 weeks.
- Presence of diseases such as inflammatory arthritis, neurological diseases, fibromyalgia, malignant tumors, or polymyalgia rheumatica.
- Presence of comorbidities that increase cardiovascular risk, such as hypertension, diabetes, or heart failure.
- Presence of more than one thromboembolism risk factor (obesity, history of thrombosis, prolonged immobilization, recent surgery, use of contraceptives, etc.).
- Presence of active skin lesions in the area where the sleeve will be placed, recent scars or burns, or chronic dermatological diseases that compromise skin integrity,
- Participation in upper limb exercise programs in the last month.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analysis of the Effects of a 4-week Low-intensity Training With and Without Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain
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.
- Conditions
- Rotator Cuff Related Shoulder Pain
- Being tested
- Resistance exercise with BFR, Resistance exercise without 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 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 without BFRProcedure or surgery
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 without flow restriction application (cuff applied without pressure). 30" rest between sets, 2' rest between exercises.
| Study group | Role | What they receive |
|---|---|---|
| Low resistance exercise with blood occlusion | Experimental | Eight sessions of exercise during 4 weeks, 30% repetition maximum, and 50% blood occlusion Receives: Device: Resistance exercise with BFR |
| Low resistance exercise without blood flow restriction | Active comparator | Eight sessions of exercise during 4 weeks, 30% repetition maximum, without blood occlusion Receives: Procedure: Resistance exercise without BFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Baseline, 2 weeks, and 4 weeks.
Secondary outcomes (9)
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: Baseline, 2 weeks, and 4 weeks.
Pressure pain threshold
Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer.
Measured: Before the session, immediately after, and 1 hour post-intervention
Kinesiophobia
Assessment of fear of movement or reinjury, assessed via the self-administered Tampa Scale of Kinesiophobia questionnaire.
Measured: Baseline, 2 weeks, and 4 weeks.
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.
Pain Catastrophizing
Assessment of pain catastrophizing, measured using the self-report Pain Catastrophizing Scale (PCS), which evaluates exaggerated negative mental responses to actual or anticipated pain. The final score ranges from 0 to 52, with higher scores reflecting higher levels of catastrophizing.
Measured: Baseline, 2 weeks, and 4 weeks.
Pain and Disability
Assessment of pain and disability, measured using the self-report Shoulder Pain and Disability Index (SPADI). The score ranges from 0 to 100. A score of 0 indicates best, 100 indicates worst. A higher score shows more disabillity.
Measured: Baseline, 2 weeks, and 4 weeks.
Shoulder Disability
Assessment of shoulder disability, measured using the self-report Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH). The final score ranges from 0 (no disability) to 100 (severe/maximal disability), calculated from patient-rated difficulty on a 5-point scale for 30 items, with higher scores indicating greater impairment in arm, shoulder, and hand function.
Measured: Baseline, 2 weeks, and 4 weeks.
Muscle Strength
Assessment of supraspinatus and internal and external rotator muscle strength, measured using a strap-secured handheld dynamometer.
Measured: Baseline, 2 weeks, and 4 weeks.
Satisfaction with methodology
Assessment of participant satisfaction with the methodology used, measured at the end of the program using a 5-point scale: very satisfied (5), satisfied (4), neutral (3), dissatisfied (2), very dissatisfied (1).
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 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
- Adrián Escriche-Escuder, PhD, Principal investigator, Universitat de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324993
- Sponsor's protocol ID
- 2025-FIS-3960959
- Status last verified
- Jun 2026
- First submitted
- 23 Dec 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study will be available from the corresponding author upon reasonable request.