Effects of Blood Flow Restriction Training in Rotator Cuff Related Shoulder Pain

Not Applicable

Withdrawn

• Conditions: Subacromial Pain Syndrome
• Interventions: Other: Side-lying external rotation exercise with a dumbbell with 40% arterial occlusion pressure blood flow restriction; Other: Side-lying external rotation exercise with a dumbbell; Other: Side-lying external rotation exercise with a dumbbell with 80% arterial occlusion pressure blood flow restriction

• Registration Number: NCT04834271
• Lead Sponsor: University of Alcala

Brief Summary

Blood flow restriction training is widespread in sport performance areas, where it has proven to be beneficial in strength and hypertrophy development. However, there are only few studies related to its effects on subjects with pathology, and currently, there is no recent clinical trial evaluating its effects on patients with RCRSP. We are aiming to define the potential benefits, acute and short-term effects of adding blood flow restriction to a low-load exercise training for patients with RCRSP.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-04-03
• Study First Posted: 2021-04-08
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Pain around the antero-lateral (deltoid area) region of the proximal shoulder during active movements in abduction and/or external rotation.
• 3/5 positive impingement tests: Neer, Hawkins-Kennedy, empty can, painful arc, and resisted external rotation or abduction.
• Pain at rest less than 3cm in a visual analogue scale (VAS).

Exclusion Criteria

• Previous shoulder surgery.
• Being treated with physical therapy or pharmacogical therapy for shoulder pain.
• External rotation range of motion less than 45º or 50% compared to the contralateral side.
• Suspected shoulder instability (previous dislocation/subluxation, sulcus sign, anterior drawer test, anterior/posterior aprehension test, relocation test).
• Suspected cervical radiculopathy (distraction, spurling, ULNT1, squeeze test, ipsilateral rotation less than 60º)
• Presence of neck pain.
• Suspected rotator cuff tears (drop arm test, external rotation lag sign, diagnostic imaging).
• Contraindications to blood flow restriction therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise with 40% of arterial occlusion pressure blood flow restriction	Side-lying external rotation exercise with a dumbbell with 40% arterial occlusion pressure blood flow restriction	Side-lying external rotation exercise with a dumbbell (20-30% 1RM) with 40% of arterial occlusion pressure blood flow restriction.
Exercise without blood flow restriction	Side-lying external rotation exercise with a dumbbell	Side-lying external rotation exercise with a dumbbell (20-30% 1RM) without blood flow restriction.
Exercise with 80% of arterial occlusion pressure blood flow restriction	Side-lying external rotation exercise with a dumbbell with 80% arterial occlusion pressure blood flow restriction	Side-lying external rotation exercise with a dumbbell (20-30% 1RM) with 80% of arterial occlusion pressure blood flow restriction.

Primary Outcome Measures

Name	Time	Method
Conditioned Pain Modulation (CPM)	Baseline, immediately after the first treatment session, 1 month, and 2 months	Conditioned pain modulation estimated using changes in pressure pain threshold measured with a manual algometer and a sphygmomanometer.

Secondary Outcome Measures

Name	Time	Method
Pain intensity	Baseline, 1 month, and 2 months	Mean pain intensity during last week measured with a visual analogue scale (VAS), ranging from 0cm (no pain) to 10cm (worst pain)
Shoulder pain and disability index (SPADI)	Baseline, 1 month, and 2 months	The SPADI ranges from 0% (no disability) to 100% (maximum degree of disability)
Pain-free isometric strength	Baseline, immediately after the first treatment session, 1 month, and 2 months	Pain-free isometric shoulder external rotation strength measured using a hand-held dynamometer

Trial Locations

Locations (1)

Ruben Fernandez-Matias; 🇪🇸 Alcalá De Henares, Spain