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NCT Number: NCT07232511

Exercise-induced Hypoalgesia Effects of Blood Flow Restriction 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.

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Key information

Conditions

Rotator Cuff Related Shoulder Pain Behavior Motor Activity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physiotherapy, University of Valencia

Valencia, 46010, Spain

Location status: Recruiting

Location contact

Adrian Escriche-Escuder

CONTACT

[email protected]

963983853

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance exercise with low AOP

Device

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 BFR

Device

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 BFR

Device

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 BFR

Device

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 outcomes

  1. Pain intensity at rest (Visual Analogue Scale, 0-10)

    Time frame: Periprocedural

    Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.

  2. Pain intensity during movement (Visual Analogue Scale, 0-10)

    Time frame: 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 outcomes

  1. Pressure pain threshold

    Time frame: Periprocedural

    Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer

  2. Exercise tolerance with each setting

    Time frame: Periprocedural

    Exercise tolerance with each setting according to the following 5-point scale: well tolerated, tolerated, neutral, poorly tolerated, not tolerated.

  3. Occurrence of adverse effects

    Time frame: 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.

  4. Surface electromyography

    Time frame: Periprocedural

    Surface electromyography for the study of muscle recruitment (middle deltoid, infraspinatus, teres minor and trapezius muscles)

Study contacts

Contact information is provided by the study sponsor or research team.

Adrian Escriche-Escuder, PhD

CONTACT

[email protected]

+34 963 98 38 55

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Differences in Exercise-induced Hypoalgesia After a Session With Different Blood Flow Restriction Protocols in People With Rotator Cuff-related Shoulder Pain

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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