Rotator Cuff InjuriesNCT06024551
Investigation of the Efficacy of Telerehabilitation in Patients With Rotator Cuff Tendinopathy
A study testing Telerehabilitation and home exercise program in people with Rotator Cuff Injuries and Rotator Cuff Tendinitis, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to investigate the effect of telerehabilitation in patients with rotator cuff tendinopathy. The main questions it aims to answer are: Is telerehabilitation effective in improving the functional status of patients with rotator cuff tendinopathy? Is telerehabilitation effective in reducing the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rotator Cuff Injuries, Rotator Cuff Tendinitis
- What is being tested?
- Telerehabilitation and home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 15 Jun 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Rotator cuff tendinopathy
- Being able to do the prescribed exercises
- Having an access to internet and having a computer or smart phone for telerehabilitation
Who cannot join
- Patients with a neurological disease that may affect the effectiveness of exercise
- History of fracture in shoulder region
- History of surgery in shoulder region
- Patients with a psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to investigate the effect of telerehabilitation in patients with rotator cuff tendinopathy. The main questions it aims to answer are:
- Is telerehabilitation effective in improving the functional status of patients with rotator cuff tendinopathy?
- Is telerehabilitation effective in reducing the pain of rotator cuff patients?
Read the detailed description
Patients between the ages of 18-65 who were diagnosed with rotator cuff tendinopathy will be included in the study. Patients will be divided into two groups. Patients in group 1 will be given a home exercise program. Then, the patients will be called 3 times a week and it will be evaluated whether they do their exercises regularly and whether they do it correctly. At the end of the first month, the patients will be evaluated again for functionality and pain.
The patients in group 2 will be given a home exercise program and at the end of the first month, the patients will be evaluated again in terms of functionality and pain.
- Conditions
- Rotator Cuff Injuries, Rotator Cuff Tendinitis
- Being tested
- Telerehabilitation, home exercise program
- Keywords
- rotator cuff tendinopathy, telerehabilitation
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
Patients in this arm will be given telerehabilitation three times a week, for four weeks.
home exercise programOther
Patients in this arm will receive home exercise program for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients who receive telerehabilitation Receives: Other: Telerehabilitation |
| Control Group | Other | Patients who receive home exercise program Receives: Other: home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Rotator Cuff Index
Western Ontario Rotator Cuff Index is a disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to a Rotator Cuff tendinopathy. Raw scores range from 0 to 2100 with a higher score indicating decreased quality of life.
Measured: one month
Simple Shoulder Test
A questionnaire about the function of the involved shoulder. Overall scored is calculated by number of yes/number of completed items. Minimum score is 0 %and maximum is 100 %. Higher scores indicate better function.
Measured: one month
Secondary outcomes (1)
Range of motion
Shoulder joint normal range of motion will be measured using a goniometer. Normal movements of the shoulder joint are flexion 180 degrees, abduction 180 degrees, hyperextension 45 degrees, internal rotation 70 degrees and external rotation 90 degrees. Limitations will be evaluated.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start15 Dec 2023
- Primary completion15 Jan 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferruh Taşpınar, Izmir Democracy University
- Investigators
- Ferruh Taşpınar, Study director, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024551
- Sponsor's protocol ID
- TR35TR
- Status last verified
- Aug 2024
- First submitted
- 4 Apr 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Telerehabilitation in Patients With Rotator Cuff Tendinopathy
- ClinicalTrials.gov ID
- NCT06024551
- Acronym / sponsor ID
- TR35TR
- Conditions
- Rotator Cuff Injuries, Rotator Cuff Tendinitis
- Keywords
- rotator cuff tendinopathy, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 6 Sep 2023 (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.
The goal of this study is to investigate the effect of telerehabilitation in patients with rotator cuff tendinopathy. The main questions it aims to answer are:
- Is telerehabilitation effective in improving the functional status of patients with rotator cuff tendinopathy?
- Is telerehabilitation effective in reducing the pain of rotator cuff patients?
Detailed description
Patients between the ages of 18-65 who were diagnosed with rotator cuff tendinopathy will be included in the study. Patients will be divided into two groups. Patients in group 1 will be given a home exercise program. Then, the patients will be called 3 times a week and it will be evaluated whether they do their exercises regularly and whether they do it correctly. At the end of the first month, the patients will be evaluated again for functionality and pain.
The patients in group 2 will be given a home exercise program and at the end of the first month, the patients will be evaluated again in terms of functionality and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: TelerehabilitationPatients who receive telerehabilitation |
| Control Group | Other | Other: home exercise programPatients who receive home exercise program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Rotator cuff tendinopathy
- Being able to do the prescribed exercises
- Having an access to internet and having a computer or smart phone for telerehabilitation
Key exclusion criteria (4 listed)
- Patients with a neurological disease that may affect the effectiveness of exercise
- History of fracture in shoulder region
- History of surgery in shoulder region
- Patients with a psychiatric disorder
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 |
|---|---|---|
| TelerehabilitationPatients in this arm will be given telerehabilitation three times a week, for four weeks. | Other | Intervention Group |
| home exercise programPatients in this arm will receive home exercise program for four weeks | Other | Control Group |
Primary outcome
Western Ontario Rotator Cuff Index
Time frame: one month
Western Ontario Rotator Cuff Index is a disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to a Rotator Cuff tendinopathy. Raw scores range from 0 to 2100 with a higher score indicating decreased quality of life.
Simple Shoulder Test
Time frame: one month
A questionnaire about the function of the involved shoulder. Overall scored is calculated by number of yes/number of completed items. Minimum score is 0 %and maximum is 100 %. Higher scores indicate better function.
1 secondary outcome
Range of motion
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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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.
Ferruh Taşpınar study director
Izmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and home exercise program in people with Rotator Cuff Injuries and Rotator Cuff Tendinitis, run by Izmir Democracy 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 4 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: finished, as of the sponsor's last update on 9 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Rotator Cuff Index (time frame: one month). The study lists 2 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 9 Aug 2024.