Subacromial Pain SyndromeNCT04834271
Effects of Blood Flow Restriction Training in Rotator Cuff Related Shoulder Pain
A study testing Side-lying external rotation exercise with a dumbbell, Side-lying external rotation exercise with a dumbbell with 40% arterial occlusion pressure blood flow restriction and Side-lying external rotation exercise with a dumbbell with 80% arterial occlusion pressure blood flow restriction in people with Subacromial Pain Syndrome, run by University of Alcala at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Pain Syndrome
- What is being tested?
- Side-lying external rotation exercise with a dumbbell, Side-lying external rotation exercise with a dumbbell with 40% arterial occlusion pressure blood flow restriction and Side-lying external rotation exercise with a dumbbell with 80% arterial occlusion pressure blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Side-lying external rotation exercise with a dumbbellOther
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 restrictionOther
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 restrictionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise without blood flow restriction | Active comparator | Side-lying external rotation exercise with a dumbbell (20-30% 1RM) without blood flow restriction. Receives: 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. Receives: 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. Receives: Other: Side-lying external rotation exercise with a dumbbell with 80% arterial occlusion pressure blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned Pain Modulation (CPM)
Conditioned pain modulation estimated using changes in pressure pain threshold measured with a manual algometer and a sphygmomanometer.
Measured: Baseline, immediately after the first treatment session, 1 month, and 2 months
Secondary outcomes (3)
Shoulder pain and disability index (SPADI)
The SPADI ranges from 0% (no disability) to 100% (maximum degree of disability)
Measured: 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)
Measured: Baseline, 1 month, and 2 months
Pain-free isometric strength
Pain-free isometric shoulder external rotation strength measured using a hand-held dynamometer
Measured: Baseline, immediately after the first treatment session, 1 month, and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Mar 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Why it stopped: No participaints enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruben Fernandez Matias, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834271
- Sponsor's protocol ID
- 2020/57
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2021
- Last updated
- 22 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04834271
- Acronym / sponsor ID
- 2020/57
- Conditions
- Subacromial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participaints enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise without blood flow restriction | Active comparator | Other: Side-lying external rotation exercise with a dumbbellSide-lying external rotation exercise with a dumbbell (20-30% 1RM) without blood flow restriction. |
| Exercise with 40% of arterial occlusion pressure blood flow restriction | Experimental | Other: Side-lying external rotation exercise with a dumbbell with 40% arterial occlusion pressure blood flow restrictionSide-lying external rotation exercise with a dumbbell (20-30% 1RM) with 40% of arterial occlusion pressure blood flow restriction. |
| Exercise with 80% of arterial occlusion pressure blood flow restriction | Experimental | Other: Side-lying external rotation exercise with a dumbbell with 80% arterial occlusion pressure blood flow restrictionSide-lying external rotation exercise with a dumbbell (20-30% 1RM) with 80% of arterial occlusion pressure blood flow restriction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Side-lying external rotation exercise with a dumbbellSide-lying external rotation exercise with a dumbbell (20-30% 1RM). 2 times per week during 4 weeks. | Other | Exercise without blood flow restriction |
| Side-lying external rotation exercise with a dumbbell with 40% arterial occlusion pressure blood flow restrictionSide-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. | Other | 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 restrictionSide-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. | Other | Exercise with 80% of arterial occlusion pressure blood flow restriction |
Primary outcome
Conditioned Pain Modulation (CPM)
Time frame: Baseline, immediately after the first treatment session, 1 month, and 2 months
Conditioned pain modulation estimated using changes in pressure pain threshold measured with a manual algometer and a sphygmomanometer.
3 secondary outcomes
Shoulder pain and disability index (SPADI)
Time frame: Baseline, 1 month, and 2 months
Pain intensity
Time frame: Baseline, 1 month, and 2 months
Pain-free isometric strength
Time frame: Baseline, immediately after the first treatment session, 1 month, and 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Side-lying external rotation exercise with a dumbbell, Side-lying external rotation exercise with a dumbbell with 40% arterial occlusion pressure blood flow restriction and Side-lying external rotation exercise with a dumbbell with 80% arterial occlusion pressure blood flow restriction in people with Subacromial Pain Syndrome, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioned Pain Modulation (CPM) (time frame: Baseline, immediately after the first treatment session, 1 month, and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.