Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?
- Conditions
- Chronic Pain
- Registration Number
- NCT02701465
- Lead Sponsor
- Norwegian University of Science and Technology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to exhaustion, incremental test 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 Outcome Measures
Name Time Method Affected shoulder Week 0 What shoulder is affected (left/right)
Duration of symptoms Week 0 Duration of symptoms (months)
Age Week 0 Age (years)
1 repetition maximum (1RM), bilateral shoulder test Week 8 After 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.
SPADI questionnaire Pre+post-test (8 weeks in-between) Subjective pain and function outcomes (Likert scales)
Weight Week 0 Weight (kg)
Height Week 0 Height (cm)
Socioeconomic status Week 0 The patient fills in a questionnaire stating number of children, marital status, welfare status and working situation
Time to exhaustion, steady state Week 8 Subject 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 8 Baseline 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.
Trial Locations
- Locations (1)
St. Olavs Hospital, back-neck-shoulder multidiciplinary clinic
🇳🇴Trondheim, Norway