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

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 Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Exercise: local high intensity interval exercise; Other: Exercise: best clinical practice

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St. Olavs Hospital, back-neck-shoulder multidiciplinary clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Other: Exercise: 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.
Active Comparator: Control group; 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).	Other: Exercise: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to exhaustion, incremental test	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.	Week 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPADI questionnaire	Subjective pain and function outcomes (Likert scales)	Week 0
SPADI questionnaire	Subjective pain and function outcomes (Likert scales)	Pre+post-test (8 weeks in-between)
Weight	Weight (kg)	Week 0
Height	Height (cm)	Week 0
Age	Age (years)	Week 0
Duration of symptoms	Duration of symptoms (months)	Week 0
Affected shoulder	What shoulder is affected (left/right)	Week 0
Socioeconomic status	The patient fills in a questionnaire stating number of children, marital status, welfare status and working situation	Week 0
1 repetition maximum (1RM), bilateral shoulder test	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.	Week 0
1 repetition maximum (1RM), bilateral shoulder test	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.	Week 8
Time to exhaustion, steady state	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.	Week 0
Time to exhaustion, steady state	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.	Week 8
Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)	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.	Week 0
Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)	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.	Week 8

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Principal Investigator: Jan Hoff, PhD, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (Estimate): March 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Shoulder; Exercise therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 666

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO