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

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266352
• Other study ID #: 108
• Status: Completed
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: February 14, 2024

Study information

• Verified date: March 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 14, 2024
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Shoulder
• Psychological
• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Pain

Intervention

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.

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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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