Rotator Cuff TearNCT03073655
The Effects of Kinesio Tape Application With Different Verbal Input Given to With Patients With Rotator Cuff Tear
A study testing Negative Verbal Input, Neutral Verbal Input and Positive Verbal Input in people with Rotator Cuff Tear, run by Istanbul University.
Trial summary
The aim of the study to investigate the effectiveness KT application with different verbal inputs on pain, function and range of motion (ROM) on patient with rotator cuff tear. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Negative Verbal Input, Neutral Verbal Input and Positive Verbal Input
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients were included in the study if they had a partial rotator cuff tear diagnosed on clinical grounds
- No episodes of shoulder instability
- No radiographic signs of fracture of the glenoid or the greater or lesser tuberosity MRI evidence of cuff tear
- Duration of symptoms of at least 3 months,
- Inadequate response to nonoperative management (including nonsteroidal anti-inflammatory drugs, physical therapy, rest, and 1 local corticosteroid injection) Positive empty can test indicating possible supraspinatus involvement
- Positive Hawkins-Kennedy test indicating possible external impingement, -Subjective complaint of difficulty performing activities of daily living
- 20 to 50 years of age.
Who cannot join
- Patients were excluded from the study if they had inflammatory joint disease -Rheumatologic disease Osteoarthritis of humerus head
- Prior surgery on the affected shoulder
- Inability to complete questionnaires because of language problem or cognitive disorder
- Shoulder girdle fracture
- Glenohumeral dislocation/subluxation
- Acromioclavicular sprain
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- Concomitant cervical spine symptoms
- A history of shoulder surgery
- Patients who did not accept to participate
- Patients who did not come to the second evaluation.
About this study
Official title: Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
The aim of the study to investigate the effectiveness KT application with different verbal inputs on pain, function and range of motion (ROM) on patient with rotator cuff tear.
Read the detailed description
Rotator cuff tears are most common of shoulder pain and functional limitations. Kinesio tape (KT) are frequently used in the conservative treatment of shoulder pathology. Even if some studies showed that KT is effective on pain, we think that it is due to positive thoughts of the patients about KT. The aim of the study to investigate the effectiveness KT application with different verbal inputs on pain, function and range of motion (ROM) on patient with rotator cuff tear. 97 patients (Group 1, n=32; Group 2, n=33, Group 3, n=32) were randomized into 3 groups according to verbal input given to patients about the effectiveness of KT; Group 1 (it has been limited evidence of KT is effective), Group 2 (it has been not known that KT is effective or not), Group 3 (it has been known that KT has excellent result). The same standard KT was applied to 3 groups. The rest, night and pain in activity were assessed by Visual Analog Pain Scale (VAS) before, after 30 min and 24 hours after KT application. ROM assessed by goniometer and the function was evaluated by Disabilities of the Arm, Shoulder and Hand (DASH) and the American Shoulder and Elbow Surgery score (ASES) before and 24 hours of KT application. Minimal clinically important difference and effective were calculated for the assessments used in the study.
- Conditions
- Rotator Cuff Tear
- Being tested
- Negative Verbal Input, Neutral Verbal Input, Positive Verbal Input
- Keywords
- shoulder pain, shoulder function
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Verbal InputOther
The treatment group received a standardized therapeutic KT application. The physical therapist said that it has been limited evidence of KT is effective during application.
Neutral Verbal InputOther
The treatment group received a standardized therapeutic KT application. The physical therapist said that it has been not known that KT is effective or not during application.
Positive Verbal InputOther
The treatment group received a standardized therapeutic KT application. The physical therapist said that it has been known that KT has excellent result during application.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | it has been limited evidence of KT is effective Receives: Other: Negative Verbal Input |
| Group 2 | Experimental | it has been not known that KT is effective or not Receives: Other: Neutral Verbal Input |
| Group 3 | Experimental | it has been known that KT has excellent result Receives: Other: Positive Verbal Input |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Pain intensity was assessed using the VAS; each patient was asked the pain during the rest, activity, and at night (on a 0 -10 numerical pain rating scale with zero corresponding to no pain and 10 corresponding to terrible pain). The rest, night and pain in activity were assessed by VAS before, after 30 min and 24 hours after KT application
Measured: The rest, night and pain in activity were assessed by VAS before and after 30 min, before and after 24 hours of KT application
Secondary outcomes (3)
Shoulder range of motion
Shoulder ROM measurements of forward flexion, abduction, and scapular plane external -internal rotation were taken using a standard goniometer. Pain-free active ROM and passive ROM were assesment.
Measured: ROM (range of motion) assessed by goniometer before and 24 hours of KT application.
Disabilities of the Arm, Shoulder and Hand questionnaire
The Disabilities of the Arm, Shoulder and Hand questionnaire is a 30-item scale of disability symptoms used to assess a patient's health status. The scores obtained from all items are then used to calculate a score ranging from 0 (no disability) to 100 (most severe disability).Disabilities of the Arm, Shoulder and Hand (DASH) was evaluated before and 24 hours of KT application.
Measured: Disabilities of the Arm, Shoulder and Hand (DASH) was evaluated before and 24 hours of KT application.
American Shoulder and Elbow Surgery score (ASES)
The ASES (American Shoulder and Elbow Surgery score) consists of 2 sections: a patient self-evaluation component and an assessment performed by a physician. The patient self-evaluation section has 11 items that can be used to generate a score. These items are divided into 2 areas: pain (1 item) and function (0 items). The function questions ask patients whether they can perform 10 daily life activities. Additionally, they are asked whether they can do their usual work and take part in normal sporting activity. Scores on the ASES range from 0 (absence of function) to 100 (normal function). The four-point Likert scale for the function questions ranges from 0 (unable to do) to 3 (not hard). American Shoulder and Elbow Surgery score was evaluated before and 24 hours of KT application.
Measured: American Shoulder and Elbow Surgery score was evaluated before and 24 hours of KT application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
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.
- More trials run by Istanbul 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yıldız Analay Akbaba, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073655
- Sponsor's protocol ID
- IU
- Status last verified
- Mar 2017
- First submitted
- 12 Jan 2017
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
- ClinicalTrials.gov ID
- NCT03073655
- Acronym / sponsor ID
- IU
- Conditions
- Rotator Cuff Tear
- Keywords
- shoulder pain, shoulder function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Mar 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 the study to investigate the effectiveness KT application with different verbal inputs on pain, function and range of motion (ROM) on patient with rotator cuff tear.
Detailed description
Rotator cuff tears are most common of shoulder pain and functional limitations. Kinesio tape (KT) are frequently used in the conservative treatment of shoulder pathology. Even if some studies showed that KT is effective on pain, we think that it is due to positive thoughts of the patients about KT. The aim of the study to investigate the effectiveness KT application with different verbal inputs on pain, function and range of motion (ROM) on patient with rotator cuff tear. 97 patients (Group 1, n=32; Group 2, n=33, Group 3, n=32) were randomized into 3 groups according to verbal input given to patients about the effectiveness of KT; Group 1 (it has been limited evidence of KT is effective), Group 2 (it has been not known that KT is effective or not), Group 3 (it has been known that KT has excellent result). The same standard KT was applied to 3 groups. The rest, night and pain in activity were assessed by Visual Analog Pain Scale (VAS) before, after 30 min and 24 hours after KT application. ROM assessed by goniometer and the function was evaluated by Disabilities of the Arm, Shoulder and Hand (DASH) and the American Shoulder and Elbow Surgery score (ASES) before and 24 hours of KT application. Minimal clinically important difference and effective were calculated for the assessments used in the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Negative Verbal Inputit has been limited evidence of KT is effective |
| Group 2 | Experimental | Other: Neutral Verbal Inputit has been not known that KT is effective or not |
| Group 3 | Experimental | Other: Positive Verbal Inputit has been known that KT has excellent result |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients were included in the study if they had a partial rotator cuff tear diagnosed on clinical grounds
- No episodes of shoulder instability
- No radiographic signs of fracture of the glenoid or the greater or lesser tuberosity MRI evidence of cuff tear
- Duration of symptoms of at least 3 months,
- Inadequate response to nonoperative management (including nonsteroidal anti-inflammatory drugs, physical therapy, rest, and 1 local corticosteroid injection) Positive empty can test indicating possible supraspinatus involvement
Key exclusion criteria (10 listed)
- Patients were excluded from the study if they had inflammatory joint disease -Rheumatologic disease Osteoarthritis of humerus head
- Prior surgery on the affected shoulder
- Inability to complete questionnaires because of language problem or cognitive disorder
- Shoulder girdle fracture
- Glenohumeral dislocation/subluxation
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 |
|---|---|---|
| Negative Verbal InputThe treatment group received a standardized therapeutic KT application. The physical therapist said that it has been limited evidence of KT is effective during application. | Other | Group 1 |
| Neutral Verbal InputThe treatment group received a standardized therapeutic KT application. The physical therapist said that it has been not known that KT is effective or not during application. | Other | Group 2 |
| Positive Verbal InputThe treatment group received a standardized therapeutic KT application. The physical therapist said that it has been known that KT has excellent result during application. | Other | Group 3 |
Primary outcome
Visual Analogue Scale
Time frame: The rest, night and pain in activity were assessed by VAS before and after 30 min, before and after 24 hours of KT application
Pain intensity was assessed using the VAS; each patient was asked the pain during the rest, activity, and at night (on a 0 -10 numerical pain rating scale with zero corresponding to no pain and 10 corresponding to terrible pain). The rest, night and pain in activity were assessed by VAS before, after 30 min and 24 hours after KT application
3 secondary outcomes
Shoulder range of motion
Time frame: ROM (range of motion) assessed by goniometer before and 24 hours of KT application.
Disabilities of the Arm, Shoulder and Hand questionnaire
Time frame: Disabilities of the Arm, Shoulder and Hand (DASH) was evaluated before and 24 hours of KT application.
American Shoulder and Elbow Surgery score (ASES)
Time frame: American Shoulder and Elbow Surgery score was evaluated before and 24 hours of KT application.
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 13 Mar 2017.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Verbal Input, Neutral Verbal Input and Positive Verbal Input in people with Rotator Cuff Tear, run by Istanbul University.
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 7 inclusion and 10 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual Analogue Scale (time frame: The rest, night and pain in activity were assessed by VAS before and after 30 min, before and after 24 hours of KT application). 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 13 Mar 2017.