Exercise Into Pain in Subacromial Shoulder Pain

Shoulder Impingement Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553289
• Other study ID #: 18/34/379 (RCT)
• Status: Completed
• Phase: N/A
• Start date: July 30, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: May 2023
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Shoulder Pain

Intervention

Other:
• exercising into pain
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
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)

Locations

Country	Name	City	State
Belgium	Physiotherapy private practices	Antwerp

Sponsors (4)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Rotterdam University of Applied Sciences, University of Malaga, University of Southern Denmark

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global perceived effect (GPE)	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.	12 weeks
Other	Adherence	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.	12 weeks
Primary	Shoulder Pain and Disability Index (SPADI)	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.	Change from baseline to 12 weeks
Secondary	Shoulder Pain and Disability Index (SPADI)	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.	Change from baseline to 6 months
Secondary	Visual Analogue Scale (VAS)	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.	Change from baseline to 12 weeks
Secondary	Visual Analogue Scale (VAS)	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.	Change from baseline to 6 months
Secondary	Health-Related Quality of Life	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)	Change from baseline to 12 weeks
Secondary	Health-Related Quality of Life	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)	Change from baseline to 6 months
Secondary	Fear-Avoidance Beliefs Questionnaire (FABQ)	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.	Change from baseline to 12 weeks
Secondary	Fear-Avoidance Beliefs Questionnaire (FABQ)	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.	Change from baseline to 6 months
Secondary	Fear of Pain Questionnaire (FPQ-9)	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.	Change from baseline to 12 weeks
Secondary	Fear of Pain Questionnaire (FPQ-9)	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.	Change from baseline to 6 months
Secondary	Range of Movement (ROM) in internal rotation, external rotation, scaption	It is measured with the inclinometer. The unit of measure is degrees.	Change from baseline to 12 weeks
Secondary	Range of Movement (ROM) in internal rotation, external rotation, scaption	It is measured with the inclinometer. The unit of measure is degrees.	Change from baseline to 6 months
Secondary	Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption	It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.	Change from baseline to 12 weeks
Secondary	Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption	It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.	Change from baseline to 6 months
Secondary	Scapular Dyskinesis	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	Change from baseline to 12 weeks
Secondary	Scapular Dyskinesis	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	Change from baseline to 6 months
Secondary	Scapular Correction	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.	Change from baseline to 12 weeks
Secondary	Scapular Correction	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.	Change from baseline to 6 months
Secondary	Acromiohumeral Distance	it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)	Change from baseline to 12 weeks
Secondary	Acromiohumeral Distance	it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)	Change from baseline to 6 months
Secondary	Coracohumeral distance	it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)	Change from baseline to 12 weeks
Secondary	Coracohumeral distance	it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)	Change from baseline to 6 months
Secondary	Supraspinatus Tendon Thickness	it is measured with the Ultrasound in Crass position (in millimeters)	Change from baseline to 12 weeks
Secondary	Supraspinatus Tendon Thickness	it is measured with the Ultrasound in Crass position (in millimeters)	Change from baseline to 6 months
Secondary	Subscapularis Tendon Thickness	it is measured with the Ultrasound in maximal external rotation (in millimeters)	Change from baseline to 12 weeks
Secondary	Subscapularis Tendon Thickness	it is measured with the Ultrasound in maximal external rotation (in millimeters)	Change from baseline to 6 months