Does The Type of Exercise Influence Outcome in Rotator Cuff Related Shoulder Pain

NCT03892603 | Completed

• 1 other identifier: RCT RCRSP 2019
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain; Rotator Cuff Injury; Rotator Cuff Tendinitis; Rotator Cuff Impingement Syndrome

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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).

  0 and 24 weeks

Secondary Outcomes (19)

• Change in symptoms and functional limitations from baseline to 3 weeks: WORC (Western Ontario Rotator Cuff Index)

  0 and 3 weeks

• Change in symptoms and functional limitations from baseline to 6 weeks: WORC

  0 and 6 weeks

• Change in symptoms and functional limitations from baseline to 12 weeks: WORC

  0 and 12 weeks

• Change in symptoms and functional limitations from baseline to 24 weeks: WORC

  0 and 24 weeks

• Change in pain from baseline to 3 weeks: BPI-SF (Brief Pain Inventory-Short Form)

  0 and 3 weeks

Study Arms (3)

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

Interventions

Strengthening exercises program OTHER

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.

Strengthening exercises program

Motor control exercises program OTHER

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.

Motor control exercises program

Education and advice OTHER

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?

Education and advice

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)

Québec, Quebec, G1M 2S8, Canada

Location

Related Publications (2)

• 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.

  PMID: 36796859 DERIVED

• 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.

  PMID: 33154058 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Rotator Cuff Injuries; Shoulder Impingement Syndrome

Interventions

Educational Status; Counseling

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jean-Sébastien Roy, PT, PhD

  Laval University, Quebec, Qc (Canada)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Faculty of Medicine

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 27, 2019
• Study Start: May 14, 2019
• Primary Completion: June 29, 2021
• Study Completion: May 29, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

CA (1)