]>
IRCT20251202068202N1 IRCT 2025-12-10 Tehran University of Medical Sciences Comparing the effects of low-load resistance training with and without BFR in shoulder impingement syndrome To compare the effects of low-load resistance training with and without blood flow restriction on thickness, strength and pain of shoulder girdle muscles in individuals with shoulder impingement syndrome 2025-12-22 anticipated 28 Complete https://irct.ir/trial/87907 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method used is balanced block randomization with a block size of 4. The unit of randomization is the individual participant. The study did not employ stratified randomization, meaning no specific stratification variables (such as age or disease severity) were used to create subgroups before randomization. The primary tool for implementing randomization was sequentially numbered, sealed, opaque envelopes. The random sequence was built by an independent researcher prior to the study's commencement. This was done by listing all possible combinations that would result in 2 allocations to Group A (LLRT) and 2 allocations to Group B (LLRT+BFR) within each block of 4 participants. This sequence was transcribed and placed into the sealed envelopes, Blinding description: This trial implements a structured blinding protocol where participants are blinded to their group assignment through allocation concealment using sequentially numbered, sealed, opaque envelopes, coupled with a sham procedure for the control group to mimic the sensory experience of the BFR cuff. The treating physiotherapist administering the interventions cannot be blinded due to the necessary application of the BFR technique. The principal investigator overseeing the trial remains blinded to group allocation during active data collection and analysis to prevent bias. Crucially, all outcome assessors are blinded: a clinical assessor, separate from the treating therapist, conducts all physical and questionnaire-based evaluations without knowledge of the assignment, and a radiologist performs all ultrasound measurements independently with no information on the participant's group. N/A shoulder impingement syndrome. Intervention 1: Intervention group: Low-load resistance training (LLRT) with Blood Flow Restriction (BFR). Participants in this group will perform exercises at 20-40% of 1RM. An active BFR cuff will be applied to the proximal arm and inflated to a pressure set at 50% of the individual's pre-determined Limb Occlusion Pressure (LOP) to partially restrict arterial inflow and venous return during exercise. This group will also receive standard passive physiotherapy (hot pack, TENS, ultrasound). Intervention 2: Control group: Low-load resistance training (LLRT) with sham Blood Flow Restriction (BFR). Participants in this group will perform exercises at 20-40% of 1RM. A sham BFR cuff will be applied to the proximal arm; it will be inflated to a minimal, non-therapeutic pressure to provide the sensory experience without creating meaningful blood flow restriction. This group will also receive standard passive physiotherapy (hot pack, TENS, ultrasound). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Bahram Tabatabaei
No. 35 - Habibollah Aqighi Alley - North Kerman Street - Tehran
Tehran Iran (Islamic Republic of) 1634869467 +98 915 655 1679 tabatabaei.bah@gmail.com Tehran University of Medical Sciences scientific Dr. Mostafa Rahimi
Physiotherapy Section - Amiralam Hospital - Beginning of Saadi Street - Enghelab Street (Dorvazeh Dolat) - Tehran
Tehran Iran (Islamic Republic of) 1145765111 +98 912 207 0616 rahimim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 40 to 60 years Literacy in Persian experiencing shoulder pain for a maximum of 3 months Shoulder pain at night or during overhead activities greater than or equal to 3 based on VAS scale Positive Painful arc test and at least three of the following tests: Neer- Hawkins-kennedy- Empty can- infraspinatus 40 years 60 years Both Contraindications for the use of BFR, including:• History of blood clots (DVT)• Blood pressure higher than 180 mmHg• Acute infection, peripheral vascular problems, varicose veins, or cancer.• History of hemorrhagic or thrombotic strokes.• History of arterial fibrillation Simultaneous pain in both shoulders Suffering from frozen shoulder Positive drop arm test indicating a complete rotator cuff tear History of surgery, fracture, or dislocation in the shoulder area Use of anti-inflammatory drugs during the day while undergoing the physiotherapy course M75.4 Impingement syndrome of shoulder Treatment - Other Treatment - Other Intervention group: Low-load resistance training (LLRT) with Blood Flow Restriction (BFR). Participants in this group will perform exercises at 20-40% of 1RM. An active BFR cuff will be applied to the proximal arm and inflated to a pressure set at 50% of the individual's pre-determined Limb Occlusion Pressure (LOP) to partially restrict arterial inflow and venous return during exercise. This group will also receive standard passive physiotherapy (hot pack, TENS, ultrasound). Control group: Low-load resistance training (LLRT) with sham Blood Flow Restriction (BFR). Participants in this group will perform exercises at 20-40% of 1RM. A sham BFR cuff will be applied to the proximal arm; it will be inflated to a minimal, non-therapeutic pressure to provide the sensory experience without creating meaningful blood flow restriction. This group will also receive standard passive physiotherapy (hot pack, TENS, ultrasound). Isometric muscle strength of the rotator cuff muscles (supraspinatus). Timepoint: pre and post intervention. Method of measurement: hand-held, fixed dynamometer. Thickness of supraspinatus, infraspinatus, middle trapezius, and biceps muscles at rest. Timepoint: pre and post intervention. Method of measurement: B-mode ultrasonography (model: Supersonic MACH30). Night pain and pain while elevating the shoulder. Timepoint: pre and post intervention. Method of measurement: Numeric pain rating scale. Pain pressure threshold on 2 points (end of supraspinatus muscle and thenar area of ​​the affected side). Timepoint: pre and post intervention. Method of measurement: digital algometer. Functional pain and disability. Timepoint: pre and post intervention. Method of measurement: Shoulder Pain and Disability Index questionnaire. Tehran University of Medical Sciences Approved 2025-05-20 Research Ethics Committees of Amir A'lam Hospital Complex Amiralam Hospital- Beginning of Saadi Street-Enghelab Street (Dorvaze Dolat)-Tehran Tehran Tehran Iran (Islamic Republic of)