TendinopathyNCT05549817
Synchronous and Asynchronous Telerehabilitation Methods in Patients With Shoulder Tendinopathy
A study testing Synchronous Exercise Program and Asynchronous Exercise Program in people with Tendinopathy and Shoulder Pain, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tendinopathy, Shoulder Pain
- What is being tested?
- Synchronous Exercise Program and Asynchronous Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 25 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences
Istanbul, Maltepe, 1464185881
EREN TİMURTAS, Pt, MSc, +905356670080, erentimurtas@hotmail.com
About this study
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.
- Conditions
- Tendinopathy, Shoulder Pain
- Being tested
- Synchronous Exercise Program, Asynchronous Exercise Program
- Medical subject headings
- Tendinopathy, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronous Exercise ProgramOther
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 ProgramOther
The exercise program consisted of exercises by recommended guidelines for shoulder tendinopathy patients which includes various strengthening, stretching, and proprioceptive exercises with progression.
| Study group | Role | What they receive |
|---|---|---|
| Synchronous Telerehabilitation Group | Experimental | 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. Receives: Other: Synchronous Exercise Program |
| Asynchronous Telerehabilitation Group | Active comparator | 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. Receives: Other: Asynchronous Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The pain was measured at long-term follow-up assessment in the 16th week.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The quality of life was measured at long-term follow-up assessment in the 16th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Jun 2022
- Primary completion10 Nov 2022 (estimated)
- Study completion25 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549817
- Sponsor's protocol ID
- 2022/67
- Status last verified
- Aug 2022
- First submitted
- 7 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synchronous and Asynchronous Telerehabilitation Methods in Patients With Shoulder Tendinopathy
- ClinicalTrials.gov ID
- NCT05549817
- Acronym / sponsor ID
- 2022/67
- Conditions
- Tendinopathy, Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 10 Nov 2022 (estimated)
- Study completion
- 25 Nov 2022 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synchronous Telerehabilitation Group | Experimental | Other: Synchronous Exercise ProgramThe 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. |
| Asynchronous Telerehabilitation Group | Active comparator | Other: Asynchronous Exercise ProgramThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synchronous Exercise ProgramThe exercise program consisted of exercises by recommended guidelines for shoulder tendinopathy patients which includes various strengthening, stretching, and proprioceptive exercises with progression. | Other | Synchronous Telerehabilitation Group |
| Asynchronous Exercise ProgramThe exercise program consisted of exercises by recommended guidelines for shoulder tendinopathy patients which includes various strengthening, stretching, and proprioceptive exercises with progression. | Other | Asynchronous Telerehabilitation Group |
Primary outcome
Numerical Pain Rating Scale (NPRS)
Time frame: The pain was measured at baseline.
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)
Time frame: The pain was measured at mid-treatment in the 4th week.
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)
Time frame: The pain was measured at the end of treatment in the 8th week.
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)
Time frame: The pain was measured at long-term follow-up assessment in the 16th week.
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.
8 secondary outcomes
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: The disability was measured at baseline.
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: The disability was measured at mid-treatment in the 4th week.
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: The disability was measured at the end of treatment in the 8th week.
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: The disability was measured at long-term follow-up assessment in the 16th week.
Short Form-36 (SF-36)
Time frame: The quality of life was measured at baseline.
Short Form-36 (SF-36)
Time frame: The quality of life was measured at mid-treatment in the 4th week.
Short Form-36 (SF-36)
Time frame: The quality of life was measured at the end of treatment in the 8th week.
Short Form-36 (SF-36)
Time frame: The quality of life was measured at long-term follow-up assessment in the 16th week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronous Exercise Program and Asynchronous Exercise Program in people with Tendinopathy and Shoulder Pain, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eren Timurtaş, Ph.D. (+905384855543, selcukhalit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (NPRS) (time frame: The pain was measured at baseline.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.