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Clinical Trials/NCT04834271
NCT04834271
Withdrawn
Not Applicable

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

University of Alcala1 site in 1 countryStarted: March 1, 2021Last updated:

Overview

Phase
Not Applicable
Status
Withdrawn
Sponsor
University of Alcala
Locations
1
Primary Endpoint
Conditioned Pain Modulation (CPM)

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Pain intensity(Baseline, 1 month, and 2 months)
  • Shoulder pain and disability index (SPADI)(Baseline, 1 month, and 2 months)
  • Pain-free isometric strength(Baseline, immediately after the first treatment session, 1 month, and 2 months)

Investigators

Sponsor
University of Alcala
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ruben Fernandez Matias

Clinical Professor

University of Alcala

Study Sites (1)

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