Effectiveness of Physical Activity on Pain, Functionality and Quality of Life in Patients With Rotator Cuff Tears
Study Details
Study Description
Brief Summary
Rotator cuff tears are caused by acute trauma or tendon degeneration as a result of chronic repetitive microtraumas with aging. Shoulder pain, limitation of joint range and muscle weakness resulting from rotator cuff tears cause loss of function during daily living activities and this has a negative impact on the patient's quality of life. Exercises have an important place in rotator cuff treatment. Although there are many types, including ROM, strengthening, stretching, and flexibility, there is no clarity on the most effective type of exercise.Physical activity and exercise applications are used as an auxiliary or alternative method to reduce the severity and frequency of pain in patients with chronic pain. When we reviewed the literature, we could not find any randomized controlled trial on the effectiveness of physical activity in studies conducted with patients with rotator cuff tears. We hypothesized that adding physical activity to the treatment of a rotator cuff tear would make a significant difference. Therefore, the aim of this study was to investigate the effect of physical activity applied in addition to supervised exercise on pain, functional status and quality of life in patients with rotator cuff tears.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Rotator cuff tears are caused by acute trauma or tendon degeneration as a result of chronic repetitive microtraumas with aging. Shoulder pain, limitation of joint range and muscle weakness resulting from rotator cuff tears cause loss of function during daily living activities and this has a negative impact on the patient's quality of life. Exercises have an important place in rotator cuff treatment. Although there are many types, including Range of Motion (ROM), strengthening, stretching, and flexibility, there is no clarity on the most effective type of exercise. Physical activity is defined as any body movement produced by skeletal muscles that requires a certain amount of energy expenditure. It has been stated that patients with rotator cuff tears are affected in mental activities and participation in social life as well as physical activities. Regular physical activity contributes to physical, psychological and emotional well-being. Physical activity and exercise applications are used as an auxiliary or alternative method to reduce the severity and frequency of pain in patients with chronic pain. When investigators reviewed the literature, investigators could not find any randomized controlled trial on the effectiveness of physical activity in studies conducted with patients with rotator cuff tears. Investigators hypothesized that adding physical activity to the treatment of a rotator cuff tear would make a significant difference. Therefore, the aim of this study was to investigate the effect of physical activity applied in addition to supervised exercise on pain, functional status and quality of life in patients with rotator cuff tears. This study will be designed as a prospective randomized controlled trial. According to the power analysis result, 46 patients will be randomized into two groups(Treatment Group=23, Control Group=23).The Treatment Group (TG) will be included in an exercise program consisting of supervised exercise and physical activity (30 minutes of moderate-intensity walking). The Control Group (KG) will be included in the program consisting of supervised exercises only. The treatment will last for a total of 3 weeks, 5 days a week. The primary outcomes are Numeric Pain Rating Scale (NPRS), The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES), Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH), Rotator Cuff Quality of Life (RC-QOL) Western-Ontario Rotator Cuff Index (WORC) scores. Secondary outcome is Global Rate of Changes (GRC) scores. Physiotherapy applications and evaluations (initial, 3rd week and 6th week) are planned to be performed by the same physiotherapist.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Group The Treatment Group (TG) was included in an exercise program consisting of supervised exercise and physical activity (30 minutes of moderate-intensity walking). |
Other: exercise program consisting of supervised exercise and physical activity
The Treatment Group (TG) will be included in an exercise program consisting of supervised exercise and physical activity (30 minutes of moderate-intensity walking).
|
| Active Comparator: Control Group The Control Group (KG) was included in the program consisting of only supervised exercises. |
Other: exercises program consisting of only supervised exercises.
The Control Group (KG) will be included in the program consisting of only supervised exercises.
|
Outcome Measures
Primary Outcome Measures
- Numeric Pain Rating Scale (NPRS) [change from baseline NPRS at 3 week]
The pain will be measured at activity and at night using a NPRS. Patients are asked to rate their pain ranging from 0 to 10 (0: no pain, 10: the worst pain imaginable)
- The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES) [change from baseline ASES score at 3 week]
The ASES score ranges from 0-100. Higher scores indicate better functional ability.
- Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH) [change from baseline Quick DASH score at 3 week]
The Quick DASH is a 11-item questionnaire used to assess upper limb functionality. The score ranges from 0 (no disability) to 100 (most severe disability).
- Rotator Cuff Quality of Life (RC-QOL) [change from baseline RC-QOL score at 3 week]
RC-QOL consists of 34 items and each question consists of a line between 0 and 100. The point on the line is measured with a ruler and the value is written. Higher values indicate better quality of life.
- Western-Ontario Rotator Cuff Index (WORC) [change from baseline WORC score at 3 week]
WORC-E motions consist of 3 items. Each question is answered with a 100 mm Visual Analog Scale (VAS). Lower scores indicate better quality of life.
Secondary Outcome Measures
- Global Rate of Changes (GRC) [change from baseline GRC score at 3 week]
GRC is used to determine the effectiveness of treatment by questioning the patient's improvement or worsening over time. In our study, a 7-point scale (-3: much worse, -2: worse, -1: slightly worse, 0: same, 1: slightly better, 2: quite good, 3: much better) was used.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject age of more than 40 years
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Atraumatic partial rotator cuff tear documented by MRI
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Having at least 3 months of unilateral shoulder pain
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Positive Hawkins Kennedy test
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Positive Empty can test
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Absence of radiological findings of fracture in the humeral greater tubercle or glenoid cavity
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Obtaining informed written consent
Exclusion Criteria:
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Having a full-thickness or massive rotator cuff tear
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History of trauma related to onset of symptoms
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Having undergone surgery on the same shoulder
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Shoulder passive external rotation<30˚ and elevation<120˚
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Frozen shoulder
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Shoulder instability
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Presence of shoulder problems caused by systemic diseases
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Having psychological, emotional or cognitive problems
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Malignancy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Istanbul University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DR2023