Clinical trial NCT04553289: Exercise Into Pain in Subacromial Shoulder Pain
Official title: Exercise Into Pain in Subacromial Shoulder Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Keywords: shoulder pain
subacromial impingement syndrome
exercise therapy
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University of Malaga
name: Rotterdam University of Applied Sciences
name: University of Southern Denmark
First posted: 2020-09-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Change from baseline to 6 months
measure: Visual Analogue Scale (VAS)
timeFrame: Change from baseline to 12 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: Change from baseline to 6 months
measure: Health-Related Quality of Life
timeFrame: Change from baseline to 12 weeks
measure: Health-Related Quality of Life
timeFrame: Change from baseline to 6 months
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Change from baseline to 12 weeks
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Change from baseline to 6 months
measure: Fear of Pain Questionnaire (FPQ-9)
timeFrame: Change from baseline to 12 weeks
measure: Fear of Pain Questionnaire (FPQ-9)
timeFrame: Change from baseline to 6 months
measure: Range of Movement (ROM) in internal rotation, external rotation, scaption
timeFrame: Change from baseline to 12 weeks
measure: Range of Movement (ROM) in internal rotation, external rotation, scaption
timeFrame: Change from baseline to 6 months
measure: Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
timeFrame: Change from baseline to 12 weeks
measure: Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
timeFrame: Change from baseline to 6 months
measure: Scapular Dyskinesis
timeFrame: Change from baseline to 12 weeks
measure: Scapular Dyskinesis
timeFrame: Change from baseline to 6 months
measure: Scapular Correction
timeFrame: Change from baseline to 12 weeks
measure: Scapular Correction
timeFrame: Change from baseline to 6 months
measure: Acromiohumeral Distance
timeFrame: Change from baseline to 12 weeks
measure: Acromiohumeral Distance
timeFrame: Change from baseline to 6 months
measure: Coracohumeral distance
timeFrame: Change from baseline to 12 weeks
measure: Coracohumeral distance
timeFrame: Change from baseline to 6 months
measure: Supraspinatus Tendon Thickness
timeFrame: Change from baseline to 12 weeks
measure: Supraspinatus Tendon Thickness
timeFrame: Change from baseline to 6 months
measure: Subscapularis Tendon Thickness
timeFrame: Change from baseline to 12 weeks
measure: Subscapularis Tendon Thickness
timeFrame: Change from baseline to 6 months
Other outcomes:
measure: Global perceived effect (GPE)
timeFrame: 12 weeks
measure: Adherence
timeFrame: 12 weeks
Locations:
city: Antwerp
country: Belgium
facility: Physiotherapy private practices
Study officials:
affiliation: Universiteit Antwerpen
name: Filip Struyf, Professor
role: PRINCIPAL_INVESTIGATOR
References: