Effects of a 4-week Low-intensity Training With Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Valencia

About this trial

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.

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

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resistance exercise with 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 without BFR

    Procedure/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.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Low resistance exercise with blood occlusionExperimental treatment 1 intervention
Group B: Low resistance exercise without blood flow restrictionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
Baseline, 2 weeks, and 4 weeks.

Secondary 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
Baseline, 2 weeks, and 4 weeks.
2

Pressure pain threshold

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

Time frame
Before the session, immediately after, and 1 hour post-intervention
3

Kinesiophobia

Assessment of fear of movement or reinjury, assessed via the self-administered Tampa Scale of Kinesiophobia questionnaire.

Time frame
Baseline, 2 weeks, and 4 weeks.
4

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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