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Completed

NCT Number: NCT02701465

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Olavs Hospital, back-neck-shoulder multidiciplinary clinic

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Exercise: local high intensity interval exercise

Other

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

Other

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).

Primary outcomes

  1. 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

  1. SPADI questionnaire

    Time frame: Week 0

    Subjective pain and function outcomes (Likert scales)

  2. SPADI questionnaire

    Time frame: Pre+post-test (8 weeks in-between)

    Subjective pain and function outcomes (Likert scales)

  3. Weight

    Time frame: Week 0

    Weight (kg)

  4. Height

    Time frame: Week 0

    Height (cm)

  5. Age

    Time frame: Week 0

    Age (years)

  6. Duration of symptoms

    Time frame: Week 0

    Duration of symptoms (months)

  7. Affected shoulder

    Time frame: Week 0

    What shoulder is affected (left/right)

  8. Socioeconomic status

    Time frame: Week 0

    The patient fills in a questionnaire stating number of children, marital status, welfare status and working situation

  9. 1 repetition maximum (1RM), bilateral shoulder test

    Time frame: Week 0

    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.

  10. 1 repetition maximum (1RM), bilateral shoulder test

    Time frame: 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.

  11. Time to exhaustion, steady state

    Time frame: Week 0

    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.

  12. Time to exhaustion, steady state

    Time frame: 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.

  13. Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)

    Time frame: Week 0

    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.

  14. Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2016
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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