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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701465
• Other study ID #: 666
• Status: Completed
• Phase: N/A
• Start date: January 2, 2016
• Est. completion date: April 2018

Study information

• Verified date: March 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.
• 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).

Locations

Country	Name	City	State
Norway	St. Olavs Hospital, back-neck-shoulder multidiciplinary clinic	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	SPADI questionnaire	Subjective pain and function outcomes (Likert scales)	Week 0
Secondary	SPADI questionnaire	Subjective pain and function outcomes (Likert scales)	Pre+post-test (8 weeks in-between)
Secondary	Weight	Weight (kg)	Week 0
Secondary	Height	Height (cm)	Week 0
Secondary	Age	Age (years)	Week 0
Secondary	Duration of symptoms	Duration of symptoms (months)	Week 0
Secondary	Affected shoulder	What shoulder is affected (left/right)	Week 0
Secondary	Socioeconomic status	The patient fills in a questionnaire stating number of children, marital status, welfare status and working situation	Week 0
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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