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Completed

NCT Number: NCT05266352

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

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

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Key information

Conditions

Rotator Cuff Tears Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Shoulder Pathological Conditions, Signs and Symptoms Psychological Rotator Cuff Injuries Rupture Shoulder Injuries Shoulder Pain Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised exercise program

Other

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.

Home exercise program

Diagnostic Test

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.

Primary outcomes

  1. Constant-Murley Score

    Time frame: Baseline

    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.

Secondary outcomes

  1. Constant-Murley Score

    Time frame: At the end of 8-week intervention

    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.

  2. Visual Analogue Scale (VAS)

    Time frame: Baseline

    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.

  3. Visual Analogue Scale (VAS)

    Time frame: At the end of 8-week intervention

    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.

  4. Active Range of Motion (AROM) Assessment

    Time frame: Baseline

    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.

  5. Active Range of Motion (AROM) Assessment

    Time frame: At the end of 8-week intervention

    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.

  6. Pain Catastrophizing Scale (PCS)

    Time frame: Baseline

    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).

  7. Pain Catastrophizing Scale (PCS)

    Time frame: At the end of the 8-week intervention

    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).

  8. The Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline

    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.

  9. The Hospital Anxiety and Depression Scale (HADS)

    Time frame: At the end of the 8-week intervention

    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.

  10. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline

    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.

  11. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: At the end of the 8-week intervention

    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.

  12. Short Form-12 (SF-12)

    Time frame: Baseline

    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.

  13. Short Form-12 (SF-12)

    Time frame: At the end of the 8-week intervention

    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.

  14. Global Rating of Change (GRC)

    Time frame: At the end of the 8-week intervention

    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.

  15. Exercise Dairy

    Time frame: At the end of the 8-week intervention

    A self reported adherence to home exercise program will be assessed using the exercise dairy.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 4, 2022
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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