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

Effects of Blood Flow Restriction Training on Central Mechanisms of Pain Modulation in Subjects With Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Subacromial Pain Syndrome
• Intervention / Treatment: Other: Side-lying external rotation exercise with a dumbbell; 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 with 80% arterial occlusion pressure blood flow restriction

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alcalá De Henares, Spain, 28805
    • Rubén Fernández-Matías

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise without blood flow restriction; Side-lying external rotation exercise with a dumbbell (20-30% 1RM) without blood flow restriction.	Other: 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.
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alcala

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 3, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 2020/57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No