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

Subacromial Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04834271
• Other study ID #: 2020/57
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: November 2022
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Pain
• Subacromial Pain Syndrome

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Ruben Fernandez-Matias	Alcalá De Henares

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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