Synchronous and Asynchronous Telerehabilitation Methods in Patients With Shoulder Tendinopathy

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.

Study Overview

• Status: Recruiting
• Conditions: Tendinopathy; Shoulder Pain
• Intervention / Treatment: Other: Synchronous Exercise Program; Other: Asynchronous Exercise Program

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eren Timurtaş, Ph.D.; Phone Number: +905384855543; Email: selcukhalit@gmail.com

Study Locations

• Turkey
  • Maltepe
    • Istanbul, Maltepe, Turkey, 1464185881
      • Recruiting
      • Faculty of Health Sciences
      • Contact: EREN TİMURTAS, Pt, MSc; Phone Number: +905356670080; Email: erentimurtas@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Synchronous Telerehabilitation Group; 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.	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.
Active Comparator: Asynchronous Telerehabilitation 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): November 10, 2022
• Study Completion (Anticipated): November 25, 2022

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Arthralgia; Tendinopathy; Shoulder Pain
• Other Study ID Numbers: 2022/67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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