Shoulder PainRCT-RCRSPNCT03892603
Does The Type of Exercise Influence Outcome in Rotator Cuff Related Shoulder Pain
A study testing Strengthening exercises program and Education and advice in people with Shoulder Pain and Rotator Cuff Injury, run by Laval University at 1 site in Canada.
Trial summary
Rotator cuff related shoulder pain (RCRSP) is the most common shoulder disorder and its chronicization leads to multiple consequences such as early retirement, absenteeism from work, decreased participation and quality of life and expensive yearly healthcare costs (128 739 687 $ according to CNESST). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Pain, Rotator Cuff Injury, Rotator Cuff Tendinitis
- What is being tested?
- Strengthening exercises program and Education and advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- 14 May 2019to 29 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain of at least 3 months duration
- At least one positive response in the three following categories
- Painful arc of movement (flexion; abduction)
- Positive shoulder impingement test (Neer; Kennedy-Hawkins)
- Pain during resisted isometric shoulder contraction (external rotation; abduction; Jobe)
Who cannot join
- Clinical signs of massive rotator cuff tears (gross weakness of rotator cuff muscles in the absence of pain)
- Other shoulder disorders (arthritis, adhesive capsulitis, fracture, acromioclavicular joint pathology)
- Undergone previous shoulder surgery on the same side
- Presence of significant co-morbidity (neurological disorders, rheumatoid arthritis)
- Symptomatic cervical spine pathology defined as reproduction of symptoms with active physiological cervical spine movement
- Inability to understand French or English
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)
Québec, Quebec, G1M 2S8
About this study
Official title: Rotator Cuff Related Shoulder Pain: Does The Type of Exercise Influence Outcome? - A Randomized Controlled Trial
Rotator cuff related shoulder pain (RCRSP) is the most common shoulder disorder and its chronicization leads to multiple consequences such as early retirement, absenteeism from work, decreased participation and quality of life and expensive yearly healthcare costs (128 739 687 $ according to CNESST). Even though scientific evidence has shown that prioritising physiotherapy exercises over surgery for the initial management of RCRSP is a great way to save on healthcare costs without compromising quality, it does not always result in a resolution of symptoms and patients' quality of life can still be affected thereafter: up to 30% of people with RCRSP remain symptomatic despite rehabilitation interventions. This lack of therapeutic success could be explained by a multitude of factors, but a central issue that can explain a lack of improvement is an inappropriate dosage or choice of exercises prescribed. The purpose of this study is to compare the effectiveness of 3 non-operative methods of delivering shoulder management (2 types of exercises and an advice and education only group) on symptoms and functional limitations for people with RCRSP. Results from this project should help us further our knowledge on which non-operative treatment to promote with patients presenting with RCRSP, thus decreasing the proportion of individuals experiencing pain even after going through a rehabilitation program.
Read the detailed description
Context : Musculoskeletal injuries lead to the second largest number of years lived with a disability, just behind mental health problems. Among those, shoulder problems are widespread and become even more common over the years. 70% of the population will experience an episode of shoulder pain during their lifetime and 30% of people over 65 years old live with daily shoulder pain. Unfortunately, the resolution of shoulder pain is often slow and incomplete and about 40 to 50% of symptomatic individuals will still experience pain one year after the onset of their painful episode. Rotator cuff related shoulder pain (RCRSP) is the most common type of injury in this region. This is a broad term that includes subacromial conflict syndrome, rotator cuff tendinopathy, and non-traumatic tears of rotator cuff tendons. There is ample evidence to suggest that physiotherapy exercises are the preferred approach as the first intervention for managing this condition, without having an impact on the quality of recovery. Unfortunately, for many patients, this approach does not lead to a significant decrease in symptoms and may result in a decrease in their quality of life. This lack of therapeutic success could be explained by a multitude of factors: psychosocial, physical, genetic, lifestyle, complex problems related to pain and lack of adherence to the exercise program. Another important element that may explain this lack of improvement is an inappropriate dosage and / or choice of prescribed exercises.
Objectives : The primary objective of this randomized clinical trial is to compare the short, medium, and long-term effects, in terms of symptoms and functional limitations, of three different options (education, strengthening, motor control) for the management of individuals with RCRSP. A secondary objective is to explore the effects of these interventions on shoulder control (acromiohumeral distance), subacromial structures (thickness of the supraspinatus and infraspinatus tendons), kinesiophobia and pain catastrophization.
Methods : 123 individuals between the ages of 18 and 75 with RCRSP for more than 3 months will be recruited and randomly assigned to one of three 12-week interventions: 1) counseling and education only; 2) scapulohumeral and scapulothoracic muscles strengthening exercises; 3) Motor control program paired with global exercises. Before being assigned to their respective group, patients will undergo an initial assessment including self-administered questionnaires on symptoms and functional limitations (QuickDASH, WORC, BPI-SF, TSK, PCS) as well as ultrasound measurements of the shoulder (acromiohumeral distance and thickness of supraspinatus and infraspinatus tendons). The questionnaires will be administered again at 3, 6, 12 and 24 weeks after the inclusion of the participants in the project and the ultrasound measurements will be re-evaluated at 12 weeks. Initial demographic data will be compared (independent t-test and square-test) to establish comparability of groups. Two-way ANOVA analyzes will be used to analyze and compare the effects of the three programs on the primary outcome (QuickDASH) and the other questionnaires (3 interventions x 5 times [0, 3, 6, 12 and 24 weeks]) as well as for the ultrasound measurements (3 interventions X 2 times [0 and 12 weeks]) (SPSS 25, proc GENLIN).
Expected results : The hypothesis is that the two exercises groups will show better results in terms of symptoms and functional limitations compared to the group consisting solely of counseling and education. The motor control program should allow a faster improvement of symptoms and functional limitations than the reinforcement program because, by improving muscular recruitment patterns and scapular kinematics, it will reduce control deficits and thus the probabilities to feel pain. Finally, all groups should show a decrease in kinesiophobia and pain catastrophization, but the exercises groups should result in a larger one, as participants will have to move their arms in ranges previously limited by pain and / or fears related to pain, or perform muscle contractions of near maximal intensity.
- Conditions
- Shoulder Pain, Rotator Cuff Injury, Rotator Cuff Tendinitis, Rotator Cuff Impingement Syndrome
- Being tested
- Strengthening exercises program, Motor control exercises program, Education and advice
- Medical subject headings
- Shoulder Pain, Rotator Cuff Injuries, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening exercises programOther
Participants from this group will be given a progressive shoulder strengthening exercises program based on 1 RM that will involve isometric, concentric and eccentric contractions. The exercises will target shoulder internal/external rotators and abductors and the scapular muscles. They will have to exercise every other day for 12 weeks. At each session with the therapist (6 over a 12 week period), strength will be reassessed and the program will be progressed accordingly. Any questions or concerns will also be addressed and participants will be requested to complete a paper based or digital record of their exercise participation.
Motor control exercises programOther
Each session will start with a series of clinical tests that will look at the influence of different corrections to alleviate symptoms during upper limb movements.The tests will be performed in a sequential format through four key areas: thoracic repositioning, scapula facilitation, humeral head procedures and neuromodulatory techniques. If a correction reduces pain, that technique will then be performed as exercises and incorporated into the participant's functional movement. In addition, motor control exercises during arm elevation, progressed through a standardized 6-phase retraining sequence, will be executed. Retraining phases will be graded according to: 1) resistance applied on the shoulder; and 2) use or non-use of feedback. Once participants reach pain free execution, the program will be progressed into re-education exercises according to the participants' work, sport and activities of daily living and will incorporate activities involving the upper and lower limbs.
Education and adviceOther
Each participant will be given written information about the shoulder (anatomy and function), basic pain science and will be directed to the Internet to watch a series of carefully selected educational videos. Comprehensive written advice will include: Information about the shoulder and the condition; Pain neuroscience; Activity modification (when to increase and decrease); Pain management (night and day); A series of educational videos to watch with 2 questions to answer per video: a) what was the most important message? and b) was there anything you didn't understand in the video?
| Study group | Role | What they receive |
|---|---|---|
| Strengthening exercises program | Experimental | Not described Receives: Other: Strengthening exercises program |
| Motor control exercises program | Experimental | Not described Receives: Other: Motor control exercises program |
| Education and advice | Active comparator | Not described Receives: Other: Education and advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms and functional limitations from baseline to 3 weeks: QuickDASH
The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability).
Measured: 0 and 3 weeks
Change in symptoms and functional limitations from baseline to 6 weeks: QuickDASH
The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability).
Measured: 0 and 6 weeks
Change in symptoms and functional limitations from baseline to 12 weeks: QuickDASH
The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability).
Measured: 0 and 12 weeks
Change in symptoms and functional limitations from baseline to 24 weeks: QuickDASH
The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability).
Measured: 0 and 24 weeks
Secondary outcomes (19)
Change in symptoms and functional limitations from baseline to 3 weeks: WORC (Western Ontario Rotator Cuff Index)
The WORC index is a disease-specific questionnaire developed to measure health related quality-of-life of individuals suffering from RC disorders. It contains 21 items divided into five sections: physical symptoms, sports/recreation, work, lifestyle and emotions. Each question uses a visual analogue scale representing a 100 point scale (0-100). Maximum score is 2100 and minimum is 0. Total score is reported as a percentage where 0% represents lowest functional status level and 100% represents the highest level.
Measured: 0 and 3 weeks
Change in symptoms and functional limitations from baseline to 6 weeks: WORC
The WORC index is a disease-specific questionnaire developed to measure health related quality-of-life of individuals suffering from RC disorders. It contains 21 items divided into five sections: physical symptoms, sports/recreation, work, lifestyle and emotions. Each question uses a visual analogue scale representing a 100 point scale (0-100). Maximum score is 2100 and minimum is 0. Total score is reported as a percentage where 0% represents lowest functional status level and 100% represents the highest level.
Measured: 0 and 6 weeks
Change in symptoms and functional limitations from baseline to 12 weeks: WORC
The WORC index is a disease-specific questionnaire developed to measure health related quality-of-life of individuals suffering from RC disorders. It contains 21 items divided into five sections: physical symptoms, sports/recreation, work, lifestyle and emotions. Each question uses a visual analogue scale representing a 100 point scale (0-100). Maximum score is 2100 and minimum is 0. Total score is reported as a percentage where 0% represents lowest functional status level and 100% represents the highest level.
Measured: 0 and 12 weeks
Change in symptoms and functional limitations from baseline to 24 weeks: WORC
The WORC index is a disease-specific questionnaire developed to measure health related quality-of-life of individuals suffering from RC disorders. It contains 21 items divided into five sections: physical symptoms, sports/recreation, work, lifestyle and emotions. Each question uses a visual analogue scale representing a 100 point scale (0-100). Maximum score is 2100 and minimum is 0. Total score is reported as a percentage where 0% represents lowest functional status level and 100% represents the highest level.
Measured: 0 and 24 weeks
Change in pain from baseline to 3 weeks: BPI-SF (Brief Pain Inventory-Short Form)
The BPI-SF is a validated 9 item self-administred questionnaire used to assess the intensity of pain and the interference of the pain on the patient's life. Each item is scored on a 10-point Likert scale.
Measured: 0 and 3 weeks
Change in pain from baseline to 6 weeks: BPI-SF
The BPI-SF is a validated 9 item self-administered questionnaire used to assess the intensity of pain and the interference of the pain on the patient's life. Each item is scored on a 10-point Likert scale.
Measured: 0 and 6 weeks
Change in pain from baseline to 12 weeks: BPI-SF
The BPI-SF is a validated 9 item self-administered questionnaire used to assess the intensity of pain and the interference of the pain on the patient's life. Each item is scored on a 10-point Likert scale.
Measured: 0 and 12 weeks
Change in pain from baseline to 24 weeks: BPI-SF
The BPI-SF is a validated 9 item self-administered questionnaire used to assess the intensity of pain and the interference of the pain on the patient's life. Each item is scored on a 10-point Likert scale.
Measured: 0 and 24 weeks
Change in kinesiophobia from baseline to 3 weeks: TSK (Tampa Scale of Kinesiophobia)
The Tampa Scale of Kinesiophobia (TSK) is a 17 item self-administered questionnaire that measures beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging and painful movements should be avoided. It uses a 4-point Likert scale and total score ranges from 17 (lowest degree of kinesiophobia) to 68 (highest degree of kinesiophobia).
Measured: 0 and 3 weeks
Change in kinesiophobia from baseline to 6 weeks: TSK (Tampa Scale of Kinesiophobia)
The Tampa Scale of Kinesiophobia (TSK) is a 17 item self-administered questionnaire that measures beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging and painful movements should be avoided. It uses a 4-point Likert scale and total score ranges from 17 (lowest degree of kinesiophobia) to 68 (highest degree of kinesiophobia).
Measured: 0 and 6 weeks
Change in kinesiophobia from baseline to 12 weeks: TSK (Tampa Scale of Kinesiophobia)
The Tampa Scale of Kinesiophobia (TSK) is a 17 item self-administered questionnaire that measures beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging and painful movements should be avoided. It uses a 4-point Likert scale and total score ranges from 17 (lowest degree of kinesiophobia) to 68 (highest degree of kinesiophobia).
Measured: 0 and 12 weeks
Change in kinesiophobia from baseline to 24 weeks: TSK (Tampa Scale of Kinesiophobia)
The Tampa Scale of Kinesiophobia (TSK) is a 17 item self-administered questionnaire that measures beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging and painful movements should be avoided. It uses a 4-point Likert scale and total score ranges from 17 (lowest degree of kinesiophobia) to 68 (highest degree of kinesiophobia).
Measured: 0 and 24 weeks
Change in pain catastrophization from baseline to 3 weeks: PCS (Pain Catastrophizing Scale)
The Pain Catastrophizing Scale (PCS) is a 13 item self-administered questionnaire measuring the range of catastrophic thoughts and feelings (magnified threat, ruminating thoughts and feelings of helplessness) associated with pain that individuals may experience. Items are scored on a scale from 0 (not at all) to 4 (all the time). Total score ranges from 0 (minimum) to 52 (maximum).
Measured: 0 and 3 weeks
Change in pain catastrophization from baseline to 6 weeks: PCS (Pain Catastrophizing Scale)
The Pain Catastrophizing Scale (PCS) is a 13 item self-administered questionnaire measuring the range of catastrophic thoughts and feelings (magnified threat, ruminating thoughts and feelings of helplessness) associated with pain that individuals may experience. Items are scored on a scale from 0 (not at all) to 4 (all the time). Total score ranges from 0 (minimum) to 52 (maximum).
Measured: 0 and 6 weeks
Change in pain catastrophization from baseline to 12 weeks: PCS (Pain Catastrophizing Scale)
The Pain Catastrophizing Scale (PCS) is a 13 item self-administered questionnaire measuring the range of catastrophic thoughts and feelings (magnified threat, ruminating thoughts and feelings of helplessness) associated with pain that individuals may experience. Items are scored on a scale from 0 (not at all) to 4 (all the time). Total score ranges from 0 (minimum) to 52 (maximum).
Measured: 0 and 12 weeks
Change in pain catastrophization from baseline to 24 weeks: PCS (Pain Catastrophizing Scale)
The Pain Catastrophizing Scale (PCS) is a 13 item self-administered questionnaire measuring the range of catastrophic thoughts and feelings (magnified threat, ruminating thoughts and feelings of helplessness) associated with pain that individuals may experience. Items are scored on a scale from 0 (not at all) to 4 (all the time). Total score ranges from 0 (minimum) to 52 (maximum).
Measured: 0 and 24 weeks
Change in ultrasonographic measurement of acromiohumeral distance from baseline to 12 weeks
US images of AHD will be obtained with the participants seated in a standardized position with the arm at rest and at 60° of active abduction. US measures will be obtained by placing the transducer on the anterior aspect of the lateral surface of acromion along the longitudinal axis of the humerus in a frontal plane. The AHD will be measured using the build-in electronic caliper option by manually locating the superior aspect of the humeral head and the inferior aspect of acromion and then measuring the shortest linear distance between those two landmarks. For each upper limb position, three measurements will be taken.
Measured: 0 and 12 weeks
Change in ultrasonographic measurement of supraspinatus tendon thickness from baseline to 12 weeks
Thickness of the supraspinatus (SS) tendon will be obtained with the medial aspect of the wrist against the ipsilateral anterior superior iliac spine. Measures will be obtained with the transducer perpendicularly, one centimeter behind to the anterolateral aspect of the surface of the acromion. The thickness of the SS tendon borders will be defined inferiorly as the first hyperechoic region above the anechoic articular cartilage of the humeral head, and the hyperechoic superior border of the tendon before the anechoic subdeltoid bursa.
Measured: 0 and 12 weeks
Change in ultrasonographic measurement of infraspinatus tendon thickness from baseline to 12 weeks
Infraspinatus tendon thickness will be measured at the level of the posterior border of the acromion with the hand placed on the opposite shoulder.
Measured: 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start14 May 2019
- Primary completion29 Jun 2021
- Study completion29 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Sébastien Roy, Laval University
- Investigators
- Jean-Sébastien Roy, PT, PhD, Study director, Laval University, Quebec, Qc (Canada)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892603
- Sponsor's protocol ID
- RCT RCRSP 2019
- Acronym
- RCT-RCRSP
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2019
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dube MO, Desmeules F, Lewis JS, Roy JS. Does the addition of motor control or strengthening exercises to education result in better outcomes for rotator cuff-related shoulder pain? A multiarm randomised controlled trial. Br J Sports Med. 2023 Apr;57(8):457-463. doi: 10.1136/bjsports-2021-105027. Epub 2023 Feb 16.
PubMed 36796859Dube MO, Desmeules F, Lewis J, Roy JS. Rotator cuff-related shoulder pain: does the type of exercise influence the outcomes? Protocol of a randomised controlled trial. BMJ Open. 2020 Nov 5;10(11):e039976. doi: 10.1136/bmjopen-2020-039976.
PubMed 33154058
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotator Cuff Related Shoulder Pain: Does The Type of Exercise Influence Outcome? - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03892603
- Acronym / sponsor ID
- RCT-RCRSP / RCT RCRSP 2019
- Conditions
- Shoulder Pain, Rotator Cuff Injury, Rotator Cuff Tendinitis, Rotator Cuff Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 May 2022 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rotator cuff related shoulder pain (RCRSP) is the most common shoulder disorder and its chronicization leads to multiple consequences such as early retirement, absenteeism from work, decreased participation and quality of life and expensive yearly healthcare costs (128 739 687 $ according to CNESST). Even though scientific evidence has shown that prioritising physiotherapy exercises over surgery for the initial management of RCRSP is a great way to save on healthcare costs without compromising quality, it does not always result in a resolution of symptoms and patients' quality of life can still be affected thereafter: up to 30% of people with RCRSP remain symptomatic despite rehabilitation interventions. This lack of therapeutic success could be explained by a multitude of factors, but a central issue that can explain a lack of improvement is an inappropriate dosage or choice of exercises prescribed. The purpose of this study is to compare the effectiveness of 3 non-operative methods of delivering shoulder management (2 types of exercises and an advice and education only group) on symptoms and functional limitations for people with RCRSP. Results from this project should help us further our knowledge on which non-operative treatment to promote with patients presenting with RCRSP, thus decreasing the proportion of individuals experiencing pain even after going through a rehabilitation program.
Detailed description
Context : Musculoskeletal injuries lead to the second largest number of years lived with a disability, just behind mental health problems. Among those, shoulder problems are widespread and become even more common over the years. 70% of the population will experience an episode of shoulder pain during their lifetime and 30% of people over 65 years old live with daily shoulder pain. Unfortunately, the resolution of shoulder pain is often slow and incomplete and about 40 to 50% of symptomatic individuals will still experience pain one year after the onset of their painful episode. Rotator cuff related shoulder pain (RCRSP) is the most common type of injury in this region. This is a broad term that includes subacromial conflict syndrome, rotator cuff tendinopathy, and non-traumatic tears of rotator cuff tendons. There is ample evidence to suggest that physiotherapy exercises are the preferred approach as the first intervention for managing this condition, without having an impact on the quality of recovery. Unfortunately, for many patients, this approach does not lead to a significant decrease in symptoms and may result in a decrease in their quality of life. This lack of therapeutic success could be explained by a multitude of factors: psychosocial, physical, genetic, lifestyle, complex problems related to pain and lack of adherence to the exercise program. Another important element that may explain this lack of improvement is an inappropriate dosage and / or choice of prescribed exercises.
Objectives : The primary objective of this randomized clinical trial is to compare the short, medium, and long-term effects, in terms of symptoms and functional limitations, of three different options (education, strengthening, motor control) for the management of individuals with RCRSP. A secondary objective is to explore the effects of these interventions on shoulder control (acromiohumeral distance), subacromial structures (thickness of the supraspinatus and infraspinatus tendons), kinesiophobia and pain catastrophization.
Methods : 123 individuals between the ages of 18 and 75 with RCRSP for more than 3 months will be recruited and randomly assigned to one of three 12-week interventions: 1) counseling and education only; 2) scapulohumeral and scapulothoracic muscles strengthening exercises; 3) Motor control program paired with global exercises. Before being assigned to their respective group, patients will undergo an initial assessment including self-administered questionnaires on symptoms and functional limitations (QuickDASH, WORC, BPI-SF, TSK, PCS) as well as ultrasound measurements of the shoulder (acromiohumeral distance and thickness of supraspinatus and infraspinatus tendons). The questionnaires will be administered again at 3, 6, 12 and 24 weeks after the inclusion of the participants in the project and the ultrasound measurements will be re-evaluated at 12 weeks. Initial demographic data will be compared (independent t-test and square-test) to establish comparability of groups. Two-way ANOVA analyzes will be used to analyze and compare the effects of the three programs on the primary outcome (QuickDASH) and the other questionnaires (3 interventions x 5 times [0, 3, 6, 12 and 24 weeks]) as well as for the ultrasound measurements (3 interventions X 2 times [0 and 12 weeks]) (SPSS 25, proc GENLIN).
Expected results : The hypothesis is that the two exercises groups will show better results in terms of symptoms and functional limitations compared to the group consisting solely of counseling and education. The motor control program should allow a faster improvement of symptoms and functional limitations than the reinforcement program because, by improving muscular recruitment patterns and scapular kinematics, it will reduce control deficits and thus the probabilities to feel pain. Finally, all groups should show a decrease in kinesiophobia and pain catastrophization, but the exercises groups should result in a larger one, as participants will have to move their arms in ranges previously limited by pain and / or fears related to pain, or perform muscle contractions of near maximal intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strengthening exercises program | Experimental | Other: Strengthening exercises program |
| Motor control exercises program | Experimental | Other: Motor control exercises program |
| Education and advice | Active comparator | Other: Education and advice |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain of at least 3 months duration
- At least one positive response in the three following categories
Key exclusion criteria (6 listed)
- Clinical signs of massive rotator cuff tears (gross weakness of rotator cuff muscles in the absence of pain)
- Other shoulder disorders (arthritis, adhesive capsulitis, fracture, acromioclavicular joint pathology)
- Undergone previous shoulder surgery on the same side
- Presence of significant co-morbidity (neurological disorders, rheumatoid arthritis)
- Symptomatic cervical spine pathology defined as reproduction of symptoms with active physiological cervical spine movement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengthening exercises programParticipants from this group will be given a progressive shoulder strengthening exercises program based on 1 RM that will involve isometric, concentric and eccentric contractions. The exercises will target shoulder internal/external rotators and abductors and the scapular muscles. They will have to exercise every other day for 12 weeks. At each session with the therapist (6 over a 12 week period), strength will be reassessed and the program will be progressed accordingly. Any questions or concerns will also be addressed and participants will be requested to complete a paper based or digital record of their exercise participation. | Other | Strengthening exercises program |
| Motor control exercises programEach session will start with a series of clinical tests that will look at the influence of different corrections to alleviate symptoms during upper limb movements.The tests will be performed in a sequential format through four key areas: thoracic repositioning, scapula facilitation, humeral head procedures and neuromodulatory techniques. If a correction reduces pain, that technique will then be performed as exercises and incorporated into the participant's functional movement. In addition, motor control exercises during arm elevation, progressed through a standardized 6-phase retraining sequence, will be executed. Retraining phases will be graded according to: 1) resistance applied on the shoulder; and 2) use or non-use of feedback. Once participants reach pain free execution, the program will be progressed into re-education exercises according to the participants' work, sport and activities of daily living and will incorporate activities involving the upper and lower limbs. | Other | Motor control exercises program |
| Education and adviceEach participant will be given written information about the shoulder (anatomy and function), basic pain science and will be directed to the Internet to watch a series of carefully selected educational videos. Comprehensive written advice will include: Information about the shoulder and the condition; Pain neuroscience; Activity modification (when to increase and decrease); Pain management (night and day); A series of educational videos to watch with 2 questions to answer per video: a) what was the most important message? and b) was there anything you didn't understand in the video? | Other | Education and advice |
Primary outcome
Change in symptoms and functional limitations from baseline to 3 weeks: QuickDASH
Time frame: 0 and 3 weeks
The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability).
Change in symptoms and functional limitations from baseline to 6 weeks: QuickDASH
Time frame: 0 and 6 weeks
The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability).
Change in symptoms and functional limitations from baseline to 12 weeks: QuickDASH
Time frame: 0 and 12 weeks
The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability).
Change in symptoms and functional limitations from baseline to 24 weeks: QuickDASH
Time frame: 0 and 24 weeks
The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability).
19 secondary outcomes
Change in symptoms and functional limitations from baseline to 3 weeks: WORC (Western Ontario Rotator Cuff Index)
Time frame: 0 and 3 weeks
Change in symptoms and functional limitations from baseline to 6 weeks: WORC
Time frame: 0 and 6 weeks
Change in symptoms and functional limitations from baseline to 12 weeks: WORC
Time frame: 0 and 12 weeks
Change in symptoms and functional limitations from baseline to 24 weeks: WORC
Time frame: 0 and 24 weeks
Change in pain from baseline to 3 weeks: BPI-SF (Brief Pain Inventory-Short Form)
Time frame: 0 and 3 weeks
Change in pain from baseline to 6 weeks: BPI-SF
Time frame: 0 and 6 weeks
Change in pain from baseline to 12 weeks: BPI-SF
Time frame: 0 and 12 weeks
Change in pain from baseline to 24 weeks: BPI-SF
Time frame: 0 and 24 weeks
Change in kinesiophobia from baseline to 3 weeks: TSK (Tampa Scale of Kinesiophobia)
Time frame: 0 and 3 weeks
Change in kinesiophobia from baseline to 6 weeks: TSK (Tampa Scale of Kinesiophobia)
Time frame: 0 and 6 weeks
Change in kinesiophobia from baseline to 12 weeks: TSK (Tampa Scale of Kinesiophobia)
Time frame: 0 and 12 weeks
Change in kinesiophobia from baseline to 24 weeks: TSK (Tampa Scale of Kinesiophobia)
Time frame: 0 and 24 weeks
Change in pain catastrophization from baseline to 3 weeks: PCS (Pain Catastrophizing Scale)
Time frame: 0 and 3 weeks
Change in pain catastrophization from baseline to 6 weeks: PCS (Pain Catastrophizing Scale)
Time frame: 0 and 6 weeks
Change in pain catastrophization from baseline to 12 weeks: PCS (Pain Catastrophizing Scale)
Time frame: 0 and 12 weeks
Change in pain catastrophization from baseline to 24 weeks: PCS (Pain Catastrophizing Scale)
Time frame: 0 and 24 weeks
Change in ultrasonographic measurement of acromiohumeral distance from baseline to 12 weeks
Time frame: 0 and 12 weeks
Change in ultrasonographic measurement of supraspinatus tendon thickness from baseline to 12 weeks
Time frame: 0 and 12 weeks
Change in ultrasonographic measurement of infraspinatus tendon thickness from baseline to 12 weeks
Time frame: 0 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Derived from this study: PubMed 36796859Dube MO, Desmeules F, Lewis JS, Roy JS. Does the addition of motor control or strengthening exercises to education result in better outcomes for rotator cuff-related shoulder pain? A multiarm randomised controlled trial. Br J Sports Med. 2023 Apr;57(8):457-463. doi: 10.1136/bjsports-2021-105027. Epub 2023 Feb 16.
- Derived from this study: PubMed 33154058Dube MO, Desmeules F, Lewis J, Roy JS. Rotator cuff-related shoulder pain: does the type of exercise influence the outcomes? Protocol of a randomised controlled trial. BMJ Open. 2020 Nov 5;10(11):e039976. doi: 10.1136/bmjopen-2020-039976.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Sébastien Roy, PT, PhD study director
Laval University, Quebec, Qc (Canada)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening exercises program and Education and advice in people with Shoulder Pain and Rotator Cuff Injury, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptoms and functional limitations from baseline to 3 weeks: QuickDASH (time frame: 0 and 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03892603, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.