Investigation of the Effect of Exercise Training on Psychosocial Outcomes in Rotator Cuff Tears

Investigation of the Effect of Exercise Training on Psychosocial Outcomes in Rotator Cuff

This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears; Pain, Shoulder; Psychological
• Intervention / Treatment: Other: Supervised exercise program; Diagnostic test: Home exercise program

Detailed Description

This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears. Fifty voluntary patients with partial rotator cuff tear will be randomized into two groups: Supervised exercise group (SE) and home exercise (HE) group, for a standardized 8 weeks exercise program. The primary outcome is the Constant-Murley Score (CMS). The secondary outcomes are the Visual Analogue Scale (VAS), active range of motion (AROM), Pain Catastrophizing Scale (PCS), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSI), Short Form-12 (SF-12), and Global Rating of Change (GRC). Outcome measures will be performed at baseline and at the end of 8-week intervention.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bakırkoy
    • Istanbul, Bakırkoy, Turkey, 34147
      • Istanbul University-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Forty years of age or older patients that have been diagnosed for a partial rotator cuff tear that is unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder will be included into this study.

Exclusion Criteria: Patients diagnosed with full-thickness or massive rotator cuff tear, patients who undergone previous surgery, patients diagnosed with frozen shoulder or glenohumeral instability, and athletic patients younger than 40 years of age with symptoms of acute RC tear will not be included into this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised exercise group; The group received the supervised exercise program	Other: Supervised exercise program; A structured program consisting of range of motion, postural control, scapulothoracic strengthening, glenohumeral strengthening and dynamic stabilization exercises used in conservative treatment of rotator cuff tears will be performed for 8 weeks. Patients will do the exercises under control of the physiotherapist in the clinic.
Active Comparator: Home exercise group; The group received the home exercise program	Diagnostic test: Home exercise program; A structured program consisting of range of motion, postural control, scapulothoracic strengthening, glenohumeral strengthening and dynamic stabilization exercises used in conservative treatment of rotator cuff tears will be performed for 8 weeks. Patients will do the exercises at home. Patients will visit the clinic every 2 weeks and progression of exercise program will be made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant-Murley Score	The functional level will be assessed by the Constant Murley Score, which is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant-Murley Score	The functional level will be assessed by the Constant Murley Score, which is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.	At the end of 8-week intervention
Visual Analogue Scale (VAS)	Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.	Baseline
Visual Analogue Scale (VAS)	Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.	At the end of 8-week intervention
Active Range of Motion (AROM) Assessment	The shoulder flexion, abduction, internal and external rotation ROM will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer. The process will be repeated three times in each direction, with the average value recorded.	Baseline
Active Range of Motion (AROM) Assessment	The shoulder flexion, abduction, internal and external rotation ROM will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer. The process will be repeated three times in each direction, with the average value recorded.	At the end of 8-week intervention
Pain Catastrophizing Scale (PCS)	Pain catastrophizing, which is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event will be measured using the Pain Catastrophizing Scale (PCS).	Baseline
Pain Catastrophizing Scale (PCS)	Pain catastrophizing, which is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event will be measured using the Pain Catastrophizing Scale (PCS).	At the end of the 8-week intervention
The Hospital Anxiety and Depression Scale (HADS)	The anxiety and depression will be assessed using the Pain Catastrophizing Scale (PCS), which is used to measure anxiety and depression in a general medical population of patients.	Baseline
The Hospital Anxiety and Depression Scale (HADS)	The anxiety and depression will be assessed using the Pain Catastrophizing Scale (PCS), which is used to measure anxiety and depression in a general medical population of patients.	At the end of the 8-week intervention
Pittsburgh Sleep Quality Index (PSQI)	The anxiety and depression will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.	Baseline
Pittsburgh Sleep Quality Index (PSQI)	The anxiety and depression will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.	At the end of the 8-week intervention
Short Form-12 (SF-12)	Health related quality of life will be assessed using the SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.	Baseline
Short Form-12 (SF-12)	Health related quality of life will be assessed using the SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.	At the end of the 8-week intervention
Global Rating of Change (GRC)	Patient satisfaction regarding improvement in shoulder function will be assessed by the Global Rating of Change (GRC) scale. The patients will be asked to rate their condition after a 8-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly in this study.	At the end of the 8-week intervention
Exercise Dairy	A self reported adherence to home exercise program will be assessed using the exercise dairy.	At the end of the 8-week intervention

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Investigators: Principal Investigator: Tansu Birinci, PT, PhD, Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 14, 2024

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arthralgia; Rotator Cuff Injuries; Shoulder Pain
• Other Study ID Numbers: 108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No