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

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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injuries
• Intervention / Treatment: Procedure: exercise program consisting of supervised exercise and physical activity; Procedure: exercise program consisting of only supervised exercises.

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Derya Çelik, Professor; Phone Number: 05327940169; Email: ptderya@hotmail.com
• Study Contact Backup: Name: Ümmü Öztürk, PhD(c); Phone Number: 05346749164; Email: ummuozturk90@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Activity Group; The Physical Activity (PAG) was included in an exercise program consisting of supervised exercise and physical activity (30 minutes of moderate-intensity walking).	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
Active Comparator: Control Group; The Control Group (CG) was included in the program consisting of only supervised exercises.	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): August 20, 2023
• Study Completion (Actual): August 25, 2023

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; shoulder pain; rotator cuff
• 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: DR2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

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