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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05549817
Other study ID # 2022/67
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date November 25, 2022

Study information

Verified date August 2022
Source Marmara University
Contact Eren Timurtas, Ph.D.
Phone +905384855543
Email selcukhalit@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 25, 2022
Est. primary completion date November 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Synchronous Exercise Program
The exercise program consisted of exercises by recommended guidelines for shoulder tendinopathy patients which includes various strengthening, stretching, and proprioceptive exercises with progression.
Asynchronous Exercise Program
The exercise program consisted of exercises by recommended guidelines for shoulder tendinopathy patients which includes various strengthening, stretching, and proprioceptive exercises with progression.

Locations

Country Name City State
Turkey Faculty of Health Sciences Istanbul Maltepe

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. The pain was measured at baseline.
Primary 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. The pain was measured at mid-treatment in the 4th week.
Primary 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. The pain was measured at the end of treatment in the 8th week.
Primary 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. The pain was measured at long-term follow-up assessment in the 16th week.
Secondary 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. The disability was measured at baseline.
Secondary 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. The disability was measured at mid-treatment in the 4th week.
Secondary 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. The disability was measured at the end of treatment in the 8th week.
Secondary 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. The disability was measured at long-term follow-up assessment in the 16th week.
Secondary 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. The quality of life was measured at baseline.
Secondary 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. The quality of life was measured at mid-treatment in the 4th week.
Secondary 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. The quality of life was measured at the end of treatment in the 8th week.
Secondary 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. The quality of life was measured at long-term follow-up assessment in the 16th week.
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