Clinical trial NCT02701465: Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?
Official title: Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Shoulder
Exercise therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2016-03-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Time to exhaustion, incremental test
timeFrame: Week 0
Secondary outcomes:
measure: SPADI questionnaire
timeFrame: Week 0
measure: SPADI questionnaire
timeFrame: Pre+post-test (8 weeks in-between)
measure: Weight
timeFrame: Week 0
measure: Height
timeFrame: Week 0
measure: Age
timeFrame: Week 0
measure: Duration of symptoms
timeFrame: Week 0
measure: Affected shoulder
timeFrame: Week 0
measure: Socioeconomic status
timeFrame: Week 0
measure: 1 repetition maximum (1RM), bilateral shoulder test
timeFrame: Week 0
measure: 1 repetition maximum (1RM), bilateral shoulder test
timeFrame: Week 8
measure: Time to exhaustion, steady state
timeFrame: Week 0
measure: Time to exhaustion, steady state
timeFrame: Week 8
measure: Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)
timeFrame: Week 0
measure: Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)
timeFrame: Week 8
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital, back-neck-shoulder multidiciplinary clinic
Study officials:
affiliation: Norwegian University of Science and Technology
name: Jan Hoff, PhD
role: PRINCIPAL_INVESTIGATOR
References: