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Completed

NCT Number: NCT04553289

Exercise Into Pain in Subacromial Shoulder Pain

The aim of the randomized clinical trial is to investigate if "exercising into pain" gives better results in term of clinical outcomes compared to a non-painful exercise program.

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Key information

Conditions

Shoulder Impingement Syndrome Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Injuries Shoulder Pain Signs and Symptoms Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy private practices

Antwerp, Belgium

About this study

Exercise therapy is the first choice of treatment in the treatment of subacromial shoulder pain (SSP). Guidelines suggest exercise therapy for at least three months and research underlines the importance of progressive loaded exercise therapy at high dosage. However, it is not clear which is the best type of exercise and if pain should be provoked or avoided during exercise. Recent research found that painful exercises are beneficial in short term on pain and function in patients with different kinds of chronic musculoskeletal pain. The aim is to investigate if one painful exercise can give better and faster results in the management of SSP than non-painful program.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • shoulder pain for at least 3 months, elicited in the anterolateral shoulder region
  • at least 3 out of 5 of the following tests positive: Neer test, Hawkins-Kennedy, Jobe, painful arc, external resistance test
  • resting pain should be at 2/10 maximum on verbal numerical pain rating scale (NPRS)

Exclusion criteria

  • bilateral shoulder pain
  • corticosteroid injections 6 weeks prior to the study
  • pregnancy, inability to understand spoken or written Dutch
  • clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests and drop arm test)
  • evidence of adhesive capsulitis
  • previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder
  • primary complaint of spinal pain or signs of central nervous system involvement or signs of cervical nerve root involvement; reproduction of shoulder pain with cervical rotation or axial compression
  • primary diagnosis of acromioclavicular pathology, shoulder instability
  • a radiologically confirmed fracture or previous medical imaging confirming the presence of calcification larger than 5 mm
  • presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy, psychiatric illness, osteoporosis, hemophilia, rheumatic polymyalgia)
  • more than 4h of training in sport overhead shoulder activities per week

Treatment and study plan

exercising into pain

Other

the intervention consists in 4 strength exercises: one will be performed into pain (ranging between 4 and 7 on NPRS scale) and the rest between 0 adn 2 on a NPRS scale

exercising with no/slight pain

Other

the intervention consists in 4 strength exercises and all of them will be performed in no pain/slight pain (between 0 and 2 on NPRS scale)

Primary outcomes

  1. Shoulder Pain and Disability Index (SPADI)

    Time frame: Change from baseline to 12 weeks

    There are 13 items, divided in two subscales: pain (5 items) and function (8 items). Each item is scored from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult it requires help) on a NPRS. The final score is a percentage derived from an average of the two subscales, where higher score means worse outcome.

Secondary outcomes

  1. Shoulder Pain and Disability Index (SPADI)

    Time frame: Change from baseline to 6 months

    There are 13 items, divided in two subscales: pain (5 items) and function (8 items). Each item is scored from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult it requires help) on a NPRS. The final score is a percentage derived from an average of the two subscales, where higher score means worse outcome.

  2. Visual Analogue Scale (VAS)

    Time frame: Change from baseline to 12 weeks

    It measures pain during activity, during night, in the past 24 hours. It is measured on a scale from 0 to 100, where 0=no pain, 100=worst imaginable pain.

  3. Visual Analogue Scale (VAS)

    Time frame: Change from baseline to 6 months

    It measures pain at rest, during activity, during night, in the past 24 hours. It is measured on a scale from 0 to 100, where 0=no pain, 100=worst imaginable pain.

  4. Health-Related Quality of Life

    Time frame: Change from baseline to 12 weeks

    It is measured with: 1) EQ-5D-5L (EuroQol-5 dimentions-5 levels) index: score range from less than 0 (0=value of health state equivalent to dead; negative values indicate state worse than dead) to 1 (the value of full health), with higher scores indicating higher health; 2) EQ-5D VAS (EuroQol-5 dimentions-Visual Analogue Scale), from 0 to 100 score, with 0=lowest health-related quality of life, 100=best health-related quality of life)

  5. Health-Related Quality of Life

    Time frame: Change from baseline to 6 months

    It is measured with: 1) EQ-5D-5L (EuroQol-5 dimentions-5 levels) index: score range from less than 0 (0=value of health state equivalent to dead; negative values indicate state worse than dead) to 1 (the value of full health), with higher scores indicating higher health; 2) EQ-5D VAS (EuroQol-5 dimentions-Visual Analogue Scale), from 0 to 100 score, with 0=lowest health-related quality of life, 100=best health-related quality of life)

  6. Fear-Avoidance Beliefs Questionnaire (FABQ)

    Time frame: Change from baseline to 12 weeks

    It consists of 16 items and it has 2 subscales: Physical Activity (FABQ-PA, range: 0-24) and Work (FABQ-W, range: 0-42) higher scores mean more fear avoidance beliefs affecting physical activity and/or work.

  7. Fear-Avoidance Beliefs Questionnaire (FABQ)

    Time frame: Change from baseline to 6 months

    It consists of 16 items and it has 2 subscales: Physical Activity (FABQ-PA, range: 0-24) and Work (FABQ-W, range: 0-42) higher scores mean more fear avoidance beliefs affecting physical activity and/or work.

  8. Fear of Pain Questionnaire (FPQ-9)

    Time frame: Change from baseline to 12 weeks

    It is a shortened version of the Fear of Pain Questionnaire-III. The total score ranges between 9 and 45; higher scores mean more fear and anxiety associated with pain.

  9. Fear of Pain Questionnaire (FPQ-9)

    Time frame: Change from baseline to 6 months

    It is a shortened version of the Fear of Pain Questionnaire-III. The total score ranges between 9 and 45; higher scores mean more fear and anxiety associated with pain.

  10. Range of Movement (ROM) in internal rotation, external rotation, scaption

    Time frame: Change from baseline to 12 weeks

    It is measured with the inclinometer. The unit of measure is degrees.

  11. Range of Movement (ROM) in internal rotation, external rotation, scaption

    Time frame: Change from baseline to 6 months

    It is measured with the inclinometer. The unit of measure is degrees.

  12. Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption

    Time frame: Change from baseline to 12 weeks

    It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.

  13. Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption

    Time frame: Change from baseline to 6 months

    It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.

  14. Scapular Dyskinesis

    Time frame: Change from baseline to 12 weeks

    It is measured with visual observation at rest and during movement (loaded and unloaded, in abduction and in flexion); the presence of winging, tilting or abnormal scapular movement determines the judgement about scapular dyskinesis (yes/no) at rest and during movement

  15. Scapular Dyskinesis

    Time frame: Change from baseline to 6 months

    It is measured with visual observation at rest and during movement (loaded and unloaded, in abduction and in flexion); the presence of winging, tilting or abnormal scapular movement determines the judgement about scapular dyskinesis (yes/no) at rest and during movement

  16. Scapular Correction

    Time frame: Change from baseline to 12 weeks

    it is measured with the reduction of symptoms during 2 tests: 2) the scapular assistance test (SAT); if the pain reduces after the SAT, the test is considered positive; 3) scapular retraction test (SRT); if the pain reduces after the SRT, the test is considered positive.

  17. Scapular Correction

    Time frame: Change from baseline to 6 months

    it is measured with the reduction of symptoms during 2 tests: 2) the scapular assistance test (SAT); if the pain reduces after the SAT, the test is considered positive; 3) scapular retraction test (SRT); if the pain reduces after the SRT, the test is considered positive.

  18. Acromiohumeral Distance

    Time frame: Change from baseline to 12 weeks

    it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)

  19. Acromiohumeral Distance

    Time frame: Change from baseline to 6 months

    it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)

  20. Coracohumeral distance

    Time frame: Change from baseline to 12 weeks

    it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)

  21. Coracohumeral distance

    Time frame: Change from baseline to 6 months

    it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)

  22. Supraspinatus Tendon Thickness

    Time frame: Change from baseline to 12 weeks

    it is measured with the Ultrasound in Crass position (in millimeters)

  23. Supraspinatus Tendon Thickness

    Time frame: Change from baseline to 6 months

    it is measured with the Ultrasound in Crass position (in millimeters)

  24. Subscapularis Tendon Thickness

    Time frame: Change from baseline to 12 weeks

    it is measured with the Ultrasound in maximal external rotation (in millimeters)

  25. Subscapularis Tendon Thickness

    Time frame: Change from baseline to 6 months

    it is measured with the Ultrasound in maximal external rotation (in millimeters)

Other outcomes

  1. Global perceived effect (GPE)

    Time frame: 12 weeks

    It is measured on a 7-Likert Scale, ranging from 1 (way much better) to 7 (way much worse); higher scores mean worst global perceived effect.

  2. Adherence

    Time frame: 12 weeks

    It is analysed in terms of attendance to the physiotherapist-led sessions and adherence to the home-exercise protocol. Good level of adherence is defined by: attendance of 7/9 (80%) of physiotherapist led-sessions and 22/27 (80%) days of home-exercises completed.

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • Rotterdam University of Applied Sciences
  • University of Malaga
  • University of Southern Denmark

Registry information

Official study title

Exercise Into Pain in Subacromial Shoulder Pain: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2020
Registry last updated
Aug 2, 2024

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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