Rotator Cuff Related Shoulder Pain
Conditions
Keywords
blood flow restriction, exercise, rotator cuff-related shoulder pain
Brief summary
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.
Interventions
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.
PROCEDUREResistance exercise without 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 without flow restriction application (cuff applied without pressure). 30" rest between sets, 2' rest between exercises.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during movement (Visual Analogue Scale, 0-10) | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity at rest (Visual Analogue Scale, 0-10) | 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. |
| Pressure pain threshold | 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. |
| Kinesiophobia | Baseline, 2 weeks, and 4 weeks. | Assessment of fear of movement or reinjury, assessed via the self-administered Tampa Scale of Kinesiophobia questionnaire. |
| Occurrence of adverse effects | 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. |
| Pain Catastrophizing | 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. |
| Pain and Disability | 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. |
| Shoulder Disability | 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. |
| Muscle Strength | Baseline, 2 weeks, and 4 weeks. | Assessment of supraspinatus and internal and external rotator muscle strength, measured using a strap-secured handheld dynamometer. |
| Satisfaction with methodology | 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). |
Contacts
CONTACTAdrian Escriche-Escuder, PhD
PRINCIPAL_INVESTIGATORAdrián Escriche-Escuder, PhD
Universitat de València
Outcome results
None listed