Back to resultsEffects of Blood Flow Restriction Training in Rotator Cuff Related Shoulder Pain
Primary Purpose
Subacromial Pain Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Side-lying external rotation exercise with a dumbbell
Side-lying external rotation exercise with a dumbbell with 40% arterial occlusion pressure blood flow restriction
Side-lying external rotation exercise with a dumbbell with 80% arterial occlusion pressure blood flow restriction
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Pain Syndrome
Eligibility Criteria
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.
Sites / Locations
- Ruben Fernandez-Matias
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Exercise without blood flow restriction
Exercise with 40% of arterial occlusion pressure blood flow restriction
Exercise with 80% of arterial occlusion pressure blood flow restriction
Arm Description
Side-lying external rotation exercise with a dumbbell (20-30% 1RM) without blood flow restriction.
Side-lying external rotation exercise with a dumbbell (20-30% 1RM) with 40% 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.
Outcomes
Primary Outcome Measures
Conditioned Pain Modulation (CPM)
Conditioned pain modulation estimated using changes in pressure pain threshold measured with a manual algometer and a sphygmomanometer.
Secondary Outcome Measures
Shoulder pain and disability index (SPADI)
The SPADI ranges from 0% (no disability) to 100% (maximum degree of disability)
Pain intensity
Mean pain intensity during last week measured with a visual analogue scale (VAS), ranging from 0cm (no pain) to 10cm (worst pain)
Pain-free isometric strength
Pain-free isometric shoulder external rotation strength measured using a hand-held dynamometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04834271
Brief Title
Effects of Blood Flow Restriction Training in Rotator Cuff Related Shoulder Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No participaints enrolled
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise without blood flow restriction
Arm Type
Active Comparator
Arm Description
Side-lying external rotation exercise with a dumbbell (20-30% 1RM) without blood flow restriction.
Arm Title
Exercise with 40% of arterial occlusion pressure blood flow restriction
Arm Type
Experimental
Arm Description
Side-lying external rotation exercise with a dumbbell (20-30% 1RM) with 40% of arterial occlusion pressure blood flow restriction.
Arm Title
Exercise with 80% of arterial occlusion pressure blood flow restriction
Arm Type
Experimental
Arm Description
Side-lying external rotation exercise with a dumbbell (20-30% 1RM) with 80% of arterial occlusion pressure blood flow restriction.
Intervention Type
Other
Intervention Name(s)
Side-lying external rotation exercise with a dumbbell
Intervention Description
Side-lying external rotation exercise with a dumbbell (20-30% 1RM). 2 times per week during 4 weeks.
Intervention Type
Other
Intervention Name(s)
Side-lying external rotation exercise with a dumbbell with 40% arterial occlusion pressure blood flow restriction
Intervention Description
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
Intervention Name(s)
Side-lying external rotation exercise with a dumbbell with 80% arterial occlusion pressure blood flow restriction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Conditioned Pain Modulation (CPM)
Description
Conditioned pain modulation estimated using changes in pressure pain threshold measured with a manual algometer and a sphygmomanometer.
Time Frame
Baseline, immediately after the first treatment session, 1 month, and 2 months
Secondary Outcome Measure Information:
Title
Shoulder pain and disability index (SPADI)
Description
The SPADI ranges from 0% (no disability) to 100% (maximum degree of disability)
Time Frame
Baseline, 1 month, and 2 months
Title
Pain intensity
Description
Mean pain intensity during last week measured with a visual analogue scale (VAS), ranging from 0cm (no pain) to 10cm (worst pain)
Time Frame
Baseline, 1 month, and 2 months
Title
Pain-free isometric strength
Description
Pain-free isometric shoulder external rotation strength measured using a hand-held dynamometer
Time Frame
Baseline, immediately after the first treatment session, 1 month, and 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ruben Fernandez-Matias
City
Alcalá De Henares
ZIP/Postal Code
28805
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Blood Flow Restriction Training in Rotator Cuff Related Shoulder Pain
We'll reach out to this number within 24 hrs