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RecruitingNCT07232511Updated May 4, 2026

Exercise-induced Hypoalgesia Effects of Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain

An interventional study of Resistance exercise with low AOP and Resistance exercise with moderate BFR in Rotator Cuff Related Shoulder Pain, sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by University of Valencia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Rotator Cuff Related Shoulder Pain

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Keywords

  • blood flow restriction
  • exercise
  • rotator cuff-related shoulder pain
03

In context

Motor Activity

2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 2,118 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Resistance exercise with low blood occlusion

    A single session of exercise, 30% repetition maximum, and 30% blood occlusion

    Device: Resistance exercise with low AOP

  • Experimental
    Resistance exercise with moderate blood occlusion

    A single session of exercise, 30% repetition maximum, and 50% blood occlusion

    Device: Resistance exercise with moderate BFR

  • Experimental
    Resistance exercise with high blood occlusion

    A single session of exercise, 30% repetition maximum, and 70% blood occlusion

    Device: Resistance exercise with high BFR

  • Sham comparator
    Resistance exercise with sham blood flow restriction

    A single session of exercise, 30% repetition maximum, and without blood restriction (cuff applied without pressure)

    Device: Resistance exercise with sham BFR

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Periprocedural

  2. 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

    Time frame: Periprocedural

Secondary outcomes

  1. Pressure pain threshold

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

    Time frame: Periprocedural

  2. 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.

    Time frame: Periprocedural

  3. 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.

    Time frame: Immediately after the intervention, 1 hour, 6 hours, 24 hours

  4. Surface electromyography

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

    Time frame: Periprocedural

07

Study locations

1 of 1 sites recruiting
  • Faculty of Physiotherapy, University of Valencia
    Valencia, Valencia 46010, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — The data that support the findings of this study will be available from the corresponding author upon reasonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07232511
Lead sponsor
University of Valencia
Responsible party
Adrián Escriche Escuder (PhD, University of Valencia) — Principal investigator
First posted
Nov 18, 2025
Start date
Mar 5, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 4, 2026

Study contacts

Adrian Escriche-Escuder, PhD
Contact
adrian.escriche@uv.es
+34 963 98 38 55
Adrian Escriche-Escuder, PhD
principal investigator · University of Valencia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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