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Clinical Trials/NCT02701465
NCT02701465CompletedNot Applicable

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

Norwegian University of Science and Technology1 site in 1 country24 target enrollmentStarted: January 2, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Time to exhaustion, incremental test

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts 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).

Arms & Interventions

Intervention group

Experimental

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.

Intervention: Exercise: local high intensity interval exercise (Other)

Control group

Active Comparator

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).

Intervention: Exercise: best clinical practice (Other)

Outcomes

Primary Outcomes

Time to exhaustion, incremental test

Time Frame: Week 0

participants 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 Outcomes

  • Affected shoulder(Week 0)
  • Duration of symptoms(Week 0)
  • Age(Week 0)
  • 1 repetition maximum (1RM), bilateral shoulder test(Week 8)
  • SPADI questionnaire(Pre+post-test (8 weeks in-between))
  • Weight(Week 0)
  • Height(Week 0)
  • Socioeconomic status(Week 0)
  • Time to exhaustion, steady state(Week 8)
  • Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)(Week 8)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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