Clinical trial NCT03892603: Does The Type of Exercise Influence Outcome in Rotator Cuff Related Shoulder Pain
Official title: Rotator Cuff Related Shoulder Pain: Does The Type of Exercise Influence Outcome? - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Rotator Cuff Injury
Rotator Cuff Tendinitis
Rotator Cuff Impingement Syndrome
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* Pain of at least 3 months duration
* At least one positive response in the three following categories

  1. Painful arc of movement (flexion; abduction)
  2. Positive shoulder impingement test (Neer; Kennedy-Hawkins)
  3. Pain during resisted isometric shoulder contraction (external rotation; abduction; Jobe)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in symptoms and functional limitations from baseline to 3 weeks: QuickDASH
timeFrame: 0 and 3 weeks
measure: Change in symptoms and functional limitations from baseline to 6 weeks: QuickDASH
timeFrame: 0 and 6 weeks
measure: Change in symptoms and functional limitations from baseline to 12 weeks: QuickDASH
timeFrame: 0 and 12 weeks
measure: Change in symptoms and functional limitations from baseline to 24 weeks: QuickDASH
timeFrame: 0 and 24 weeks
Secondary outcomes:
measure: Change in symptoms and functional limitations from baseline to 3 weeks: WORC (Western Ontario Rotator Cuff Index)
timeFrame: 0 and 3 weeks
measure: Change in symptoms and functional limitations from baseline to 6 weeks: WORC
timeFrame: 0 and 6 weeks
measure: Change in symptoms and functional limitations from baseline to 12 weeks: WORC
timeFrame: 0 and 12 weeks
measure: Change in symptoms and functional limitations from baseline to 24 weeks: WORC
timeFrame: 0 and 24 weeks
measure: Change in pain from baseline to 3 weeks: BPI-SF (Brief Pain Inventory-Short Form)
timeFrame: 0 and 3 weeks
measure: Change in pain from baseline to 6 weeks: BPI-SF
timeFrame: 0 and 6 weeks
measure: Change in pain from baseline to 12 weeks: BPI-SF
timeFrame: 0 and 12 weeks
measure: Change in pain from baseline to 24 weeks: BPI-SF
timeFrame: 0 and 24 weeks
measure: Change in kinesiophobia from baseline to 3 weeks: TSK (Tampa Scale of Kinesiophobia)
timeFrame: 0 and 3 weeks
measure: Change in kinesiophobia from baseline to 6 weeks: TSK (Tampa Scale of Kinesiophobia)
timeFrame: 0 and 6 weeks
measure: Change in kinesiophobia from baseline to 12 weeks: TSK (Tampa Scale of Kinesiophobia)
timeFrame: 0 and 12 weeks
measure: Change in kinesiophobia from baseline to 24 weeks: TSK (Tampa Scale of Kinesiophobia)
timeFrame: 0 and 24 weeks
measure: Change in pain catastrophization from baseline to 3 weeks: PCS (Pain Catastrophizing Scale)
timeFrame: 0 and 3 weeks
measure: Change in pain catastrophization from baseline to 6 weeks: PCS (Pain Catastrophizing Scale)
timeFrame: 0 and 6 weeks
measure: Change in pain catastrophization from baseline to 12 weeks: PCS (Pain Catastrophizing Scale)
timeFrame: 0 and 12 weeks
measure: Change in pain catastrophization from baseline to 24 weeks: PCS (Pain Catastrophizing Scale)
timeFrame: 0 and 24 weeks
measure: Change in ultrasonographic measurement of acromiohumeral distance from baseline to 12 weeks
timeFrame: 0 and 12 weeks
measure: Change in ultrasonographic measurement of supraspinatus tendon thickness from baseline to 12 weeks
timeFrame: 0 and 12 weeks
measure: Change in ultrasonographic measurement of infraspinatus tendon thickness from baseline to 12 weeks
timeFrame: 0 and 12 weeks
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)
state: Quebec
Study officials:
affiliation: Laval University, Quebec, Qc (Canada)
name: Jean-Sébastien Roy, PT, PhD
role: STUDY_DIRECTOR
References:
citation: Dube 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.