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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Valencia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: Resistance exercise with low blood occlusionExperimental treatment 1 intervention
Group B: Resistance exercise with moderate blood occlusionExperimental treatment 1 intervention
Group C: Resistance exercise with high blood occlusionExperimental treatment 1 intervention
Group D: Resistance exercise with sham blood flow restrictionSham comparator 1 intervention

Trial outcomes

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

Other outcomes

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