Back to resultsEffectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears
Primary Purpose
Rotator Cuff Tear, Pain, Shoulder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Video-Based Rehabilitation Program
Physiotherapist-Supervised Rehabilitation Program
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear focused on measuring rotator cuff, physiotherapy, video-based rehabilitation, exercise
Eligibility Criteria
Inclusion Criteria:
- Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study.
Exclusion Criteria:
- Patients that had been diagnosed for a full-thickness or massive rotator cuff tear, operated previously, had frozen shoulder or glenohumeral instability
- Younger than 40-year-old, and athletic patients with acute tear symptom were excluded from this study.
Sites / Locations
- Istanbul University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Video-Based Rehabilitation Group
Physiotherapist-Supervised Rehabilitation Group
Outcomes
Primary Outcome Measures
Shoulder Range of Motion (ROM)
The shoulder flexion, abduction, internal and external rotation ROM were evaluated with goniometer while the patient was in supine position.
Secondary Outcome Measures
Visual Analogue Scale (VAS)
The levels of pain felt at rest / activity / night were measured using visual analogue scale (VAS).
ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form
ASES is an assessment form prepared by shoulder and elbow surgeons with objective and subjective sections. The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
DASH questionnaire inquires about the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, emotional state and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the increased functional impairment.
Short Form 12 (SF-12)
SF-12 was used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Global Rating of Change (GRC) Scale
Global Rating of Change (GRC) scale was used to assess the overall satisfaction levels of the patients. Patients were asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
Full Information
NCT ID
NCT03373799
First Posted
November 25, 2017
Last Updated
December 10, 2017
Sponsor
Istanbul University
1. Study Identification
Unique Protocol Identification Number
NCT03373799
Brief Title
Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears
Official Title
Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 30, 2016 (Actual)
Primary Completion Date
March 30, 2017 (Actual)
Study Completion Date
March 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study was to investigate the efficacy of the video-based rehabilitation program on pain, functionality and quality of life in the conservative treatment of partial tears of the rotator cuff whether it was as successful as the physiotherapist-supervised rehabilitation program.
Detailed Description
In our study a common exercise program, which can be used in conservative treatment of a partial rotator cuff tear, is applied with two different methods; a video-based rehabilitation program and physiotherapist-supervised rehabilitation program. Video-based rehabilitation program was developed to investigate whether this program is effective on pain, functionality and quality of life and as successful as a physiotherapist-supervised rehabilitation program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear, Pain, Shoulder
Keywords
rotator cuff, physiotherapy, video-based rehabilitation, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Video-Based Rehabilitation Group
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Physiotherapist-Supervised Rehabilitation Group
Intervention Type
Other
Intervention Name(s)
Video-Based Rehabilitation Program
Intervention Description
In both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. A video record was made by the physiotherapist to a patient where each exercise was described in detail and the patient correctly performed the exercises according to the verbal and visual commands of the physiotherapist. This video record watched by the patients who come to the clinic and patients were asked to do the exercises in the video. Patients did the exercises under control of the physiotherapist in the clinic.
Intervention Type
Other
Intervention Name(s)
Physiotherapist-Supervised Rehabilitation Program
Intervention Description
In both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. Program was carried out by teaching the same exercises individually by the physiotherapist.
Primary Outcome Measure Information:
Title
Shoulder Range of Motion (ROM)
Description
The shoulder flexion, abduction, internal and external rotation ROM were evaluated with goniometer while the patient was in supine position.
Time Frame
Shoulder range of motion evaluation was performed first time at baseline and second time after 6 weeks rehabilitation program. After treatment "change" was assessed.
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
The levels of pain felt at rest / activity / night were measured using visual analogue scale (VAS).
Time Frame
Evaluation was performed before treatment and after 6 weeks rehabilitation program. Patients were asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
Title
ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form
Description
ASES is an assessment form prepared by shoulder and elbow surgeons with objective and subjective sections. The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.
Time Frame
Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Title
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Description
DASH questionnaire inquires about the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, emotional state and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the increased functional impairment.
Time Frame
Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Title
Short Form 12 (SF-12)
Description
SF-12 was used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Time Frame
Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Title
Global Rating of Change (GRC) Scale
Description
Global Rating of Change (GRC) scale was used to assess the overall satisfaction levels of the patients. Patients were asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
Time Frame
Evaluation was performed after 6 weeks rehabilitation program.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study.
Exclusion Criteria:
Patients that had been diagnosed for a full-thickness or massive rotator cuff tear, operated previously, had frozen shoulder or glenohumeral instability
Younger than 40-year-old, and athletic patients with acute tear symptom were excluded from this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ezgi Türkmen
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
State/Province
Bakırkoy
ZIP/Postal Code
34147
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears
We'll reach out to this number within 24 hrs