Back to resultsThe Effects of Kinesio Tape Application With Different Verbal Input Given to With Patients With Rotator Cuff Tear
Primary Purpose
Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Negative Verbal Input
Neutral Verbal Input
Positive Verbal Input
Sponsored by
About this trial
This is an interventional other trial for Rotator Cuff Tear focused on measuring shoulder pain, shoulder function
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
it has been limited evidence of KT is effective
it has been not known that KT is effective or not
it has been known that KT has excellent result
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03073655
Brief Title
The Effects of Kinesio Tape Application With Different Verbal Input Given to With Patients With Rotator Cuff Tear
Official Title
Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
shoulder pain, shoulder function
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
it has been limited evidence of KT is effective
Arm Title
Group 2
Arm Type
Experimental
Arm Description
it has been not known that KT is effective or not
Arm Title
Group 3
Arm Type
Experimental
Arm Description
it has been known that KT has excellent result
Intervention Type
Other
Intervention Name(s)
Negative Verbal Input
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Neutral Verbal Input
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Positive Verbal Input
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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
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
Secondary Outcome Measure Information:
Title
Shoulder range of motion
Description
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.
Time Frame
ROM (range of motion) assessed by goniometer before and 24 hours of KT application.
Title
Disabilities of the Arm, Shoulder and Hand questionnaire
Description
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.
Time Frame
Disabilities of the Arm, Shoulder and Hand (DASH) was evaluated before and 24 hours of KT application.
Title
American Shoulder and Elbow Surgery score (ASES)
Description
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.
Time Frame
American Shoulder and Elbow Surgery score was evaluated before and 24 hours of KT application.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effects of Kinesio Tape Application With Different Verbal Input Given to With Patients With Rotator Cuff Tear
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