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

NCT04834271 | Withdrawn

• 1 other identifier: 2020/57
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Shoulder pain and disability index (SPADI)

  Baseline, 1 month, and 2 months

• Pain intensity

  Baseline, 1 month, and 2 months

• Pain-free isometric strength

  Baseline, immediately after the first treatment session, 1 month, and 2 months

Study Arms (3)

Exercise without blood flow restriction

ACTIVE COMPARATOR

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

Other: Side-lying external rotation exercise with a dumbbell

Exercise with 40% of arterial occlusion pressure blood flow restriction

EXPERIMENTAL

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

Exercise with 80% of arterial occlusion pressure blood flow restriction

EXPERIMENTAL

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

Interventions

Side-lying external rotation exercise with a dumbbell OTHER

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

Exercise without blood flow restriction

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 (20-30% 1RM) with 40% arterial occlusion pressure blood flow restriction. 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 with 80% arterial occlusion pressure blood flow restriction 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.

Exercise with 80% of arterial occlusion pressure blood flow restriction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain around the antero-lateral (deltoid area) region of the proximal shoulder during active movements in abduction and/or external rotation.
• /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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Ruben Fernandez-Matias

Alcalá de Henares, 28805, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 8, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)