Does Physical Activity Provide Additional Benefit In Patients With Rotator Cuff Related Shoulder Pain?

Rotator Cuff Injuries Clinical Trial

Official title:

Does Physical Activity Provide Additional Benefit In Patients With Rotator Cuff Related Shoulder Pain? A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05821283
• Other study ID #: DR2023
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: August 25, 2023

Study information

• Verified date: April 2023
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rotator cuff-related shoulder pain (RCRSP) are among the most common musculoskeletal disorders and can be associated with pain, weakness, shoulder dysfunction and kinesiophobia. The management could be surgery or nonsurgical options such as medical treatment, education, activity modifications and physiotherapy. Physical activity is defined as any body movement produced by skeletal muscles that requires a certain amount of energy expenditure. Regular physical activity is proven to help prevent and manage many diseases. Beyond these people, doing physical activity have better mental health, emotional wellbeing, quality of life and lower rates of mental illness. Additionally, physical activity and exercise applications are used as an alternative method to reduce the severity and frequency of pain in patients with chronic pain. Investigators reviewed the literature, we could not find any randomized controlled trial on the effectiveness of physical activity in studies conducted with patients with RCRSP. Investigators hypothesized that adding physical activity to the treatment of RCRSP 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 RCRSP.

Description:

Rotator cuff-related shoulder pain (RCRSP) are among the most common musculoskeletal disorders and can be associated with pain, weakness, shoulder dysfunction and kinesiophobia. The management could be surgery or nonsurgical options such as medical treatment, education, activity modifications and physiotherapy. However, none of this interventions was found best additionally 30% of individuals do not report significant improvement. Physical activity is defined as any body movement produced by skeletal muscles that requires a certain amount of energy expenditure. Regular physical activity is proven to help prevent and manage many diseases such as heart disease, stroke, several cancers, diabetes, hypertension and obesity. Beyond these people, doing physical activity have better mental health, emotional wellbeing, quality of life and lower rates of mental illness. Additionally, physical activity and exercise applications are used as an alternative method to reduce the severity and frequency of pain in patients with chronic pain.

Physical activity is defined as any body movement produced by skeletal muscles that requires a certain amount of energy expenditure. Investigators reviewed the literature, investigators could not find any randomized controlled trial on the effectiveness of physical activity in studies conducted with patients with RCRSP. Investigators hypothesized that adding physical activity to the treatment of RCRSP 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 RCRSP. This study was prospective, randomized controlled; assessor-blinded trial was performed to compare the effectiveness of physical activity in addition to supervised exercise in patients with RCRSP. According to the power analysis result, 46 patients were randomized into two groups(Treatment Group=23, Control Group=23).The Physical Activity Group (PAG) was included in an exercise program consisting of supervised exercise and physical activity (30 minutes of moderate-intensity walking). The Control Group (CG) was included in the program consisting of supervised exercises only. The treatment lasted for a total of 6 weeks. The primary outcomes were 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) and secondary outcomes were Rotator Cuff Quality of Life (RC-QOL) Western-Ontario Rotator Cuff Index (WORC) and Global Rate of Changes (GRC) scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 25, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Subject age of more than 40 years

• Having at least 3 months of unilateral shoulder pain

• Presence of painful arc

• Positive Hawkins Kennedy test or positive Neer sign

• Painful shoulder abduction and external rotation with resistance

• Absence of radiological findings of fracture in the humeral greater tubercle or glenoid cavity

• Obtaining informed written consent

Exclusion Criteria:

• Having a massive rotator cuff tear (confirmed with Magnetic Resonance (MR) and positive lag sign)

• History of trauma related to onset of symptoms

• Having undergone surgery on the same shoulder

• Frozen shoulder

• Symptomatic cervical spine pathology

• Shoulder instability

• Presence of shoulder problems caused by systemic diseases, neurological disorders

• Having psychological, emotional or cognitive problems

• Previous shoulder surgery and steroid injections

• Engagement of regular physical activity

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Pain

Intervention

Procedure:
• exercise program consisting of supervised exercise and physical activity
The Physical Activity Group (PAG) included in an exercise program consisting of supervised exercise and physical activity (30 minutes of moderate-intensity walking). Patients received 6 week (2-3 times a week) rehabilitation program composed of 15 physical therapy sessions.The physical activity program was applied as moderate intensity (maximum heart rate 50-70%) walking exercise. The patients were recommended to walk for 30 minutes, 3 days a week (total of 90 minutes) for the first 3 weeks, and 30 minutes 5 days a week (total of 150 minutes) for the 2nd 3 weeks
• exercise program consisting of only supervised exercises.
The Control Group (CG) included in the program consisting of only supervised exercises. Patients received 6 week (2-3 times a week) rehabilitation program composed of 15 physical therapy sessions

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale (NPRS)	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)	change from baseline NPRS at 6 week
Primary	The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)	The ASES score ranges from 0-100. Higher scores indicate better functional ability.	change from baseline ASES score at 6 week
Primary	Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH)	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).	change from baseline Quick DASH score at 6 week
Secondary	Global Rate of Changes (GRC)	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.	change from baseline GRC score at 6 week
Secondary	Rotator Cuff Quality of Life (RC-QOL)	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.The total score ranges from 0 to 3400, with higher scores indicating higher quality of life. The percentage (%) score can also be calculated by dividing the total score obtained by 34.	change from baseline RC-QOL score at 6 week
Secondary	Western-Ontario Rotator Cuff Index (WORC)	WORC-Emotions consist of 3 items. Each question is answered with a 100 mm Visual Analog Scale (VAS). Lower scores indicate better quality of life motions consist of 3 items. Each question is answered with a 100 mm Visual Analog Scale (VAS). Lower scores indicate better quality of life.The total score ranges from 0 to 300, with lower scores indicating higher quality of life. The percentage (%) score can also be calculated by dividing the total score obtained by 3.	change from baseline WORC score at 6 week