Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07324993

Effects of a 4-week Low-intensity Training With 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

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

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

  • 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
  • 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.

Treatment and study plan

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

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.

Primary outcomes

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

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

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

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

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

  2. Pressure pain threshold

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

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

  3. Kinesiophobia

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

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

  4. 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.

  5. Pain Catastrophizing

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

    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.

  6. Pain and Disability

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

    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.

  7. Shoulder Disability

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

    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.

  8. Muscle Strength

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

    Assessment of supraspinatus and internal and external rotator muscle strength, measured using a strap-secured handheld dynamometer.

  9. Satisfaction with methodology

    Time frame: 4 weeks.

    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).

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

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Jun 9, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.