Rotator Cuff TearNCT03373799
Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears
A study testing Video-Based Rehabilitation Program and Physiotherapist-Supervised Rehabilitation Program in people with Rotator Cuff Tear and Pain, Shoulder, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the efficacy of the video-based rehabilitation program on pain, functionality and quality of life in the conservative treatment of partial tears of the rotator cuff whether it was as successful as the physiotherapist-supervised rehabilitation program. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Rotator Cuff Tear, Pain, Shoulder
- What is being tested?
- Video-Based Rehabilitation Program and Physiotherapist-Supervised Rehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2016to 30 Mar 2017
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study.
Who cannot join
- Patients that had been diagnosed for a full-thickness or massive rotator cuff tear, operated previously, had frozen shoulder or glenohumeral instability
- Younger than 40-year-old, and athletic patients with acute tear symptom were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to investigate the efficacy of the video-based rehabilitation program on pain, functionality and quality of life in the conservative treatment of partial tears of the rotator cuff whether it was as successful as the physiotherapist-supervised rehabilitation program.
Read the detailed description
In our study a common exercise program, which can be used in conservative treatment of a partial rotator cuff tear, is applied with two different methods; a video-based rehabilitation program and physiotherapist-supervised rehabilitation program. Video-based rehabilitation program was developed to investigate whether this program is effective on pain, functionality and quality of life and as successful as a physiotherapist-supervised rehabilitation program.
- Conditions
- Rotator Cuff Tear, Pain, Shoulder
- Being tested
- Video-Based Rehabilitation Program, Physiotherapist-Supervised Rehabilitation Program
- Keywords
- rotator cuff, physiotherapy, video-based rehabilitation, exercise
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Based Rehabilitation ProgramOther
In both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. A video record was made by the physiotherapist to a patient where each exercise was described in detail and the patient correctly performed the exercises according to the verbal and visual commands of the physiotherapist. This video record watched by the patients who come to the clinic and patients were asked to do the exercises in the video. Patients did the exercises under control of the physiotherapist in the clinic.
Physiotherapist-Supervised Rehabilitation ProgramOther
In both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. Program was carried out by teaching the same exercises individually by the physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Video-Based Rehabilitation Group Receives: Other: Video-Based Rehabilitation Program |
| Group 2 | Active comparator | Physiotherapist-Supervised Rehabilitation Group Receives: Other: Physiotherapist-Supervised Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Range of Motion (ROM)
The shoulder flexion, abduction, internal and external rotation ROM were evaluated with goniometer while the patient was in supine position.
Measured: Shoulder range of motion evaluation was performed first time at baseline and second time after 6 weeks rehabilitation program. After treatment "change" was assessed.
Secondary outcomes (5)
Visual Analogue Scale (VAS)
The levels of pain felt at rest / activity / night were measured using visual analogue scale (VAS).
Measured: Evaluation was performed before treatment and after 6 weeks rehabilitation program. Patients were asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form
ASES is an assessment form prepared by shoulder and elbow surgeons with objective and subjective sections. The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.
Measured: Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
DASH questionnaire inquires about the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, emotional state and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the increased functional impairment.
Measured: Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Short Form 12 (SF-12)
SF-12 was used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Measured: Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Global Rating of Change (GRC) Scale
Global Rating of Change (GRC) scale was used to assess the overall satisfaction levels of the patients. Patients were asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
Measured: Evaluation was performed after 6 weeks rehabilitation program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start30 May 2016
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Türkmen, Istanbul University
- Investigators
- Ezgi Türkmen, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373799
- Sponsor's protocol ID
- IstanbulU30
- Status last verified
- Dec 2017
- First submitted
- 25 Nov 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT03373799
- Acronym / sponsor ID
- IstanbulU30
- Conditions
- Rotator Cuff Tear, Pain, Shoulder
- Keywords
- rotator cuff, physiotherapy, video-based rehabilitation, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 May 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 14 Dec 2017 (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 aim of this study was to investigate the efficacy of the video-based rehabilitation program on pain, functionality and quality of life in the conservative treatment of partial tears of the rotator cuff whether it was as successful as the physiotherapist-supervised rehabilitation program.
Detailed description
In our study a common exercise program, which can be used in conservative treatment of a partial rotator cuff tear, is applied with two different methods; a video-based rehabilitation program and physiotherapist-supervised rehabilitation program. Video-based rehabilitation program was developed to investigate whether this program is effective on pain, functionality and quality of life and as successful as a physiotherapist-supervised rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Video-Based Rehabilitation ProgramVideo-Based Rehabilitation Group |
| Group 2 | Active comparator | Other: Physiotherapist-Supervised Rehabilitation ProgramPhysiotherapist-Supervised Rehabilitation Group |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study.
Key exclusion criteria (2 listed)
- Patients that had been diagnosed for a full-thickness or massive rotator cuff tear, operated previously, had frozen shoulder or glenohumeral instability
- Younger than 40-year-old, and athletic patients with acute tear symptom were excluded from this study.
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 |
|---|---|---|
| Video-Based Rehabilitation ProgramIn both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. A video record was made by the physiotherapist to a patient where each exercise was described in detail and the patient correctly performed the exercises according to the verbal and visual commands of the physiotherapist. This video record watched by the patients who come to the clinic and patients were asked to do the exercises in the video. Patients did the exercises under control of the physiotherapist in the clinic. | Other | Group 1 |
| Physiotherapist-Supervised Rehabilitation ProgramIn both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. Program was carried out by teaching the same exercises individually by the physiotherapist. | Other | Group 2 |
Primary outcome
Shoulder Range of Motion (ROM)
Time frame: Shoulder range of motion evaluation was performed first time at baseline and second time after 6 weeks rehabilitation program. After treatment "change" was assessed.
The shoulder flexion, abduction, internal and external rotation ROM were evaluated with goniometer while the patient was in supine position.
5 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Evaluation was performed before treatment and after 6 weeks rehabilitation program. Patients were asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form
Time frame: Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time frame: Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Short Form 12 (SF-12)
Time frame: Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Global Rating of Change (GRC) Scale
Time frame: Evaluation was performed after 6 weeks rehabilitation program.
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 14 Dec 2017.
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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.
Ezgi Türkmen principal investigator
Istanbul 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 Video-Based Rehabilitation Program and Physiotherapist-Supervised Rehabilitation Program in people with Rotator Cuff Tear and Pain, Shoulder, run by Istanbul 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 1 inclusion and 2 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 14 Dec 2017. 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?
Shoulder Range of Motion (ROM) (time frame: Shoulder range of motion evaluation was performed first time at baseline and second time after 6 weeks rehabilitation program. After treatment "change" was assessed.). 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 14 Dec 2017.