Back to resultsSynchronous and Asynchronous Telerehabilitation Methods in Patients With Shoulder Tendinopathy
Primary Purpose
Tendinopathy, Shoulder Pain
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Synchronous Exercise Program
Asynchronous Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Tendinopathy
Eligibility Criteria
Inclusion Criteria:
- Participants between the ages of 18-65,
- Who had access to the internet and smartphone,
- Had the ability to conduct video calls included in the study.
Exclusion Criteria:
- Participants were excluded if they had COVID-19,
- Had surgery in the last 6 months,
- Had neurological and psychological disorders,
- Received physiotherapy treatment.
- Had surgery in the last 6 months,
- Had a condition that prevented them from exercising.
Sites / Locations
- Faculty of Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Synchronous Telerehabilitation Group
Asynchronous Telerehabilitation Group
Arm Description
The exercise program was applied to groups that include three participants of the synchronous group 3 days per week by video conference method on an online platform (Zoom) with the supervision of a physiotherapist. The time of the group session was organized according to the availability of participants in that group and the physiotherapist using shared calendar availability (Doodle). The physiotherapist sent a reminder to participants one hour prior to each session including the video conference meeting link. Each exercise session lasted approximately 40 minutes. For 8 weeks, a total of 24 exercise sessions were performed. The physiotherapist demonstrated the exercises as needed, supervised the group by giving real-time feedback, and progressed the exercise program according to the needs of each group.
The exercise program was prescribed and followed up 3 days per week via the mobile application (FizyoTr). A notification was sent to participants' phones via mobile application prior to each session and attendance to the exercise program was recorded. For 8 weeks, a total of 24 exercise sessions were performed. The physiotherapist progressed the exercise program according to the assessment at 4 weeks and the needs of each participant.
Outcomes
Primary Outcome Measures
Numerical Pain Rating Scale (NPRS)
Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.
Numerical Pain Rating Scale (NPRS)
Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.
Numerical Pain Rating Scale (NPRS)
Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.
Numerical Pain Rating Scale (NPRS)
Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.
Secondary Outcome Measures
Disabilities of the Arm, Shoulder and Hand (DASH)
The DASH survey was published in 1994 by the American Academy of Orthopedic Developed by Surgeons (AAOS), in upper extremity injuries. It is a questionnaire that evaluates function and disability. The survey consists of 30 questions. The first 21 questions about the difficulty of the patient during activities of daily living, 5 questions about symptoms (pain, activity-related pain, tingling, stiffness, weakness), social function, work, sleep, and patient self-esteem in each of the remaining 4 questions. A total score of 0-100 is obtained. High scores indicate severe disability (0 points: no disability, 100 points: maximum disability). Turkish validity and reliability study of the survey was conducted.
Disabilities of the Arm, Shoulder and Hand (DASH)
The DASH survey was published in 1994 by the American Academy of Orthopedic Developed by Surgeons (AAOS), in upper extremity injuries. It is a questionnaire that evaluates function and disability. The survey consists of 30 questions. The first 21 questions about the difficulty of the patient during activities of daily living, 5 questions about symptoms (pain, activity-related pain, tingling, stiffness, weakness), social function, work, sleep, and patient self-esteem in each of the remaining 4 questions. A total score of 0-100 is obtained. High scores indicate severe disability (0 points: no disability, 100 points: maximum disability). Turkish validity and reliability study of the survey was conducted.
Disabilities of the Arm, Shoulder and Hand (DASH)
The DASH survey was published in 1994 by the American Academy of Orthopedic Developed by Surgeons (AAOS), in upper extremity injuries. It is a questionnaire that evaluates function and disability. The survey consists of 30 questions. The first 21 questions about the difficulty of the patient during activities of daily living, 5 questions about symptoms (pain, activity-related pain, tingling, stiffness, weakness), social function, work, sleep, and patient self-esteem in each of the remaining 4 questions. A total score of 0-100 is obtained. High scores indicate severe disability (0 points: no disability, 100 points: maximum disability). Turkish validity and reliability study of the survey was conducted.
Disabilities of the Arm, Shoulder and Hand (DASH)
The DASH survey was published in 1994 by the American Academy of Orthopedic Developed by Surgeons (AAOS), in upper extremity injuries. It is a questionnaire that evaluates function and disability. The survey consists of 30 questions. The first 21 questions about the difficulty of the patient during activities of daily living, 5 questions about symptoms (pain, activity-related pain, tingling, stiffness, weakness), social function, work, sleep, and patient self-esteem in each of the remaining 4 questions. A total score of 0-100 is obtained. High scores indicate severe disability (0 points: no disability, 100 points: maximum disability). Turkish validity and reliability study of the survey was conducted.
Short Form-36 (SF-36)
The quality of life was assessed using SF-36, which consists of 36 items. The Sf-36 has a total of 8 subscales including physical functioning, limitation due to physical problems (physical role), limitation due to emotional problems (emotional role), vitality, bodily pain, mental health, general health, and social functioning. The Turkish version of the SF-36 has been shown to have validity and reliability.
Short Form-36 (SF-36)
The quality of life was assessed using SF-36, which consists of 36 items. The Sf-36 has a total of 8 subscales including physical functioning, limitation due to physical problems (physical role), limitation due to emotional problems (emotional role), vitality, bodily pain, mental health, general health, and social functioning. The Turkish version of the SF-36 has been shown to have validity and reliability.
Short Form-36 (SF-36)
The quality of life was assessed using SF-36, which consists of 36 items. The Sf-36 has a total of 8 subscales including physical functioning, limitation due to physical problems (physical role), limitation due to emotional problems (emotional role), vitality, bodily pain, mental health, general health, and social functioning. The Turkish version of the SF-36 has been shown to have validity and reliability.
Short Form-36 (SF-36)
The quality of life was assessed using SF-36, which consists of 36 items. The Sf-36 has a total of 8 subscales including physical functioning, limitation due to physical problems (physical role), limitation due to emotional problems (emotional role), vitality, bodily pain, mental health, general health, and social functioning. The Turkish version of the SF-36 has been shown to have validity and reliability.
Full Information
NCT ID
NCT05549817
First Posted
September 7, 2022
Last Updated
September 20, 2022
Sponsor
Marmara University
1. Study Identification
Unique Protocol Identification Number
NCT05549817
Brief Title
Synchronous and Asynchronous Telerehabilitation Methods in Patients With Shoulder Tendinopathy
Official Title
Synchronous and Asynchronous Telerehabilitation Methods in Patients With Shoulder Tendinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 10, 2022 (Anticipated)
Study Completion Date
November 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a randomized controlled trial conducted to compare the effects of synchronous and asynchronous telerehabilitation programs on pain, disability, and quality of life parameters in patients with shoulder tendinopathy in the Marmara University Physiotherapy and Rehabilitation Department.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy, Shoulder Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Synchronous Telerehabilitation Group
Arm Type
Experimental
Arm Description
The exercise program was applied to groups that include three participants of the synchronous group 3 days per week by video conference method on an online platform (Zoom) with the supervision of a physiotherapist. The time of the group session was organized according to the availability of participants in that group and the physiotherapist using shared calendar availability (Doodle). The physiotherapist sent a reminder to participants one hour prior to each session including the video conference meeting link. Each exercise session lasted approximately 40 minutes. For 8 weeks, a total of 24 exercise sessions were performed. The physiotherapist demonstrated the exercises as needed, supervised the group by giving real-time feedback, and progressed the exercise program according to the needs of each group.
Arm Title
Asynchronous Telerehabilitation Group
Arm Type
Active Comparator
Arm Description
The exercise program was prescribed and followed up 3 days per week via the mobile application (FizyoTr). A notification was sent to participants' phones via mobile application prior to each session and attendance to the exercise program was recorded. For 8 weeks, a total of 24 exercise sessions were performed. The physiotherapist progressed the exercise program according to the assessment at 4 weeks and the needs of each participant.
Intervention Type
Other
Intervention Name(s)
Synchronous Exercise Program
Intervention Description
The exercise program consisted of exercises by recommended guidelines for shoulder tendinopathy patients which includes various strengthening, stretching, and proprioceptive exercises with progression.
Intervention Type
Other
Intervention Name(s)
Asynchronous Exercise Program
Intervention Description
The exercise program consisted of exercises by recommended guidelines for shoulder tendinopathy patients which includes various strengthening, stretching, and proprioceptive exercises with progression.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NPRS)
Description
Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.
Time Frame
The pain was measured at baseline.
Title
Numerical Pain Rating Scale (NPRS)
Description
Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.
Time Frame
The pain was measured at mid-treatment in the 4th week.
Title
Numerical Pain Rating Scale (NPRS)
Description
Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.
Time Frame
The pain was measured at the end of treatment in the 8th week.
Title
Numerical Pain Rating Scale (NPRS)
Description
Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.
Time Frame
The pain was measured at long-term follow-up assessment in the 16th week.
Secondary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
The DASH survey was published in 1994 by the American Academy of Orthopedic Developed by Surgeons (AAOS), in upper extremity injuries. It is a questionnaire that evaluates function and disability. The survey consists of 30 questions. The first 21 questions about the difficulty of the patient during activities of daily living, 5 questions about symptoms (pain, activity-related pain, tingling, stiffness, weakness), social function, work, sleep, and patient self-esteem in each of the remaining 4 questions. A total score of 0-100 is obtained. High scores indicate severe disability (0 points: no disability, 100 points: maximum disability). Turkish validity and reliability study of the survey was conducted.
Time Frame
The disability was measured at baseline.
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
The DASH survey was published in 1994 by the American Academy of Orthopedic Developed by Surgeons (AAOS), in upper extremity injuries. It is a questionnaire that evaluates function and disability. The survey consists of 30 questions. The first 21 questions about the difficulty of the patient during activities of daily living, 5 questions about symptoms (pain, activity-related pain, tingling, stiffness, weakness), social function, work, sleep, and patient self-esteem in each of the remaining 4 questions. A total score of 0-100 is obtained. High scores indicate severe disability (0 points: no disability, 100 points: maximum disability). Turkish validity and reliability study of the survey was conducted.
Time Frame
The disability was measured at mid-treatment in the 4th week.
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
The DASH survey was published in 1994 by the American Academy of Orthopedic Developed by Surgeons (AAOS), in upper extremity injuries. It is a questionnaire that evaluates function and disability. The survey consists of 30 questions. The first 21 questions about the difficulty of the patient during activities of daily living, 5 questions about symptoms (pain, activity-related pain, tingling, stiffness, weakness), social function, work, sleep, and patient self-esteem in each of the remaining 4 questions. A total score of 0-100 is obtained. High scores indicate severe disability (0 points: no disability, 100 points: maximum disability). Turkish validity and reliability study of the survey was conducted.
Time Frame
The disability was measured at the end of treatment in the 8th week.
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
The DASH survey was published in 1994 by the American Academy of Orthopedic Developed by Surgeons (AAOS), in upper extremity injuries. It is a questionnaire that evaluates function and disability. The survey consists of 30 questions. The first 21 questions about the difficulty of the patient during activities of daily living, 5 questions about symptoms (pain, activity-related pain, tingling, stiffness, weakness), social function, work, sleep, and patient self-esteem in each of the remaining 4 questions. A total score of 0-100 is obtained. High scores indicate severe disability (0 points: no disability, 100 points: maximum disability). Turkish validity and reliability study of the survey was conducted.
Time Frame
The disability was measured at long-term follow-up assessment in the 16th week.
Title
Short Form-36 (SF-36)
Description
The quality of life was assessed using SF-36, which consists of 36 items. The Sf-36 has a total of 8 subscales including physical functioning, limitation due to physical problems (physical role), limitation due to emotional problems (emotional role), vitality, bodily pain, mental health, general health, and social functioning. The Turkish version of the SF-36 has been shown to have validity and reliability.
Time Frame
The quality of life was measured at baseline.
Title
Short Form-36 (SF-36)
Description
The quality of life was assessed using SF-36, which consists of 36 items. The Sf-36 has a total of 8 subscales including physical functioning, limitation due to physical problems (physical role), limitation due to emotional problems (emotional role), vitality, bodily pain, mental health, general health, and social functioning. The Turkish version of the SF-36 has been shown to have validity and reliability.
Time Frame
The quality of life was measured at mid-treatment in the 4th week.
Title
Short Form-36 (SF-36)
Description
The quality of life was assessed using SF-36, which consists of 36 items. The Sf-36 has a total of 8 subscales including physical functioning, limitation due to physical problems (physical role), limitation due to emotional problems (emotional role), vitality, bodily pain, mental health, general health, and social functioning. The Turkish version of the SF-36 has been shown to have validity and reliability.
Time Frame
The quality of life was measured at the end of treatment in the 8th week.
Title
Short Form-36 (SF-36)
Description
The quality of life was assessed using SF-36, which consists of 36 items. The Sf-36 has a total of 8 subscales including physical functioning, limitation due to physical problems (physical role), limitation due to emotional problems (emotional role), vitality, bodily pain, mental health, general health, and social functioning. The Turkish version of the SF-36 has been shown to have validity and reliability.
Time Frame
The quality of life was measured at long-term follow-up assessment in the 16th week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants between the ages of 18-65,
Who had access to the internet and smartphone,
Had the ability to conduct video calls included in the study.
Exclusion Criteria:
Participants were excluded if they had COVID-19,
Had surgery in the last 6 months,
Had neurological and psychological disorders,
Received physiotherapy treatment.
Had surgery in the last 6 months,
Had a condition that prevented them from exercising.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eren Timurtaş, Ph.D.
Phone
+905384855543
Email
selcukhalit@gmail.com
Facility Information:
Facility Name
Faculty of Health Sciences
City
Istanbul
State/Province
Maltepe
ZIP/Postal Code
1464185881
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EREN TİMURTAS, Pt, MSc
Phone
+905356670080
Email
erentimurtas@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Synchronous and Asynchronous Telerehabilitation Methods in Patients With Shoulder Tendinopathy
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