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Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?

Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02701465
Enrollment
24
Registered
2016-03-08
Start date
2016-01-02
Completion date
2018-04-30
Last updated
2019-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Shoulder, Exercise therapy

Brief summary

The purpose of this randomized clinical trial is two-fold. Firstly to see if patients suffering Subacromial Pain Syndrome can improve blood flow in the supraspinatus muscle in their shoulder, and secondly to investigate how changes in this blood flow are related to pain experience and shoulder function.

Interventions

OTHERExercise: local high intensity interval exercise

The subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group.

OTHERExercise: best clinical practice

The control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015).

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* shoulder pain for longer than three months * clinical findings indicative of subacromial pain syndrome (evaluated by Hawkins-Kennedy sign, Neers sign, painful arch and Yokum test) * normal passive range of motion of the shoulder

Exclusion criteria

* subjects unable to provide an informed consent * lack of ability to complete the intervention * full rupture of the tendon of m. supraspinatus * planned shoulder surgery, or previous shoulder surgery on affected shoulder * other musculoskeletal problem that could explain the symptoms * adhesive capsulitis * pregnancy * rheumatoid arthritis * symptomatic osteoarthritis of the shoulder/shoulder girdle * glenohumeral instability * widespread pain syndrome * unstable underlying heart disease * cortisone injections in the shoulder the last month * allergies * other serious mental or somatic disease (i.e. psychosis or active cancer disease).

Design outcomes

Primary

MeasureTime frameDescription
Time to exhaustion, incremental testWeek 0participants abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. Every minute the load is increased with 250 grams. The test is stopped if participant fails to maintain pace or movement quality, or experiences increased pain. Time at failure is noted as the result.

Secondary

MeasureTime frameDescription
WeightWeek 0Weight (kg)
HeightWeek 0Height (cm)
AgeWeek 0Age (years)
Duration of symptomsWeek 0Duration of symptoms (months)
SPADI questionnaireWeek 0Subjective pain and function outcomes (Likert scales)
Socioeconomic statusWeek 0The patient fills in a questionnaire stating number of children, marital status, welfare status and working situation
1 repetition maximum (1RM), bilateral shoulder testWeek 0After warmup: maximal strength was measured as the weight the subject could manage to lift once - usually achieved in 3-5 attempts. The movement conducted was the earlier described scapularization movement.
Time to exhaustion, steady stateWeek 0Subject abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. The load is set to 80% of the incremental time to exhaustion test. The test is stopped if the fails to maintain pace or movement quality, or the subject experience increased pain. Time at failure is noted as the result.
Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)Week 0Baseline images will be taken with ultrasonic device to confirm an intact m. supraspinatus. An intravenous line will be inserted in the contralateral arm and the patient will be injected with a bolus of contrast dye (Optison, 3 ml bolus, 0.19 mg / mL perflutren). The injection is administered by a physician related to the research project. Measurements of regional blood flow at rest made are of the supraspinatus tendon. Then the participants perform a standardized training exercise to recruit the vasculature in m. supraspinatus (scapularization to 90 degrees, 80% of TTU weight (incremental), 3 minutes). Post-exercise images are taken immediately after this.
Affected shoulderWeek 0What shoulder is affected (left/right)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026