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

NCT ID: NCT04834271

Last Updated: 2022-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-06-01

Brief Summary

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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

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Conditions

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Subacromial Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Exercise without blood flow restriction

Side-lying external rotation exercise with a dumbbell (20-30% 1RM) without blood flow restriction.

Group Type ACTIVE_COMPARATOR

Side-lying external rotation exercise with a dumbbell

Intervention Type OTHER

Side-lying external rotation exercise with a dumbbell (20-30% 1RM). 2 times per week during 4 weeks.

Exercise with 40% of 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.

Group Type EXPERIMENTAL

Side-lying external rotation exercise with a dumbbell with 40% arterial occlusion pressure blood flow restriction

Intervention Type OTHER

Side-lying external rotation exercise with a dumbbell (20-30% 1RM) with 40% arterial occlusion pressure blood flow restriction. 2 times per week during 4 weeks.

Exercise with 80% of 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.

Group Type EXPERIMENTAL

Side-lying external rotation exercise with a dumbbell with 80% arterial occlusion pressure blood flow restriction

Intervention Type OTHER

Side-lying external rotation exercise with a dumbbell (20-30% 1RM) with 80% arterial occlusion pressure blood flow restriction. 2 times per week during 4 weeks.

Interventions

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Side-lying external rotation exercise with a dumbbell

Side-lying external rotation exercise with a dumbbell (20-30% 1RM). 2 times per week during 4 weeks.

Intervention Type OTHER

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% arterial occlusion pressure blood flow restriction. 2 times per week during 4 weeks.

Intervention Type OTHER

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% arterial occlusion pressure blood flow restriction. 2 times per week during 4 weeks.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Ruben Fernandez Matias

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruben Fernandez-Matias

Alcalá de Henares, , Spain

Site Status

Countries

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Spain

Other Identifiers

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2020/57

Identifier Type: -

Identifier Source: org_study_id

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