The Effects of Kinesio Tape Application With Different Verbal Input Given to With Patients With Rotator Cuff Tear

March 9, 2017 updated by: Yıldız Analay Akbaba, Istanbul University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
it has been limited evidence of KT is effective
Other: Negative Verbal Input
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.
Experimental: Group 2
it has been not known that KT is effective or not
Other: Neutral Verbal Input
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.
Experimental: Group 3
it has been known that KT has excellent result
Other: Positive Verbal Input
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Shoulder range of motion
Time Frame: ROM (range of motion) assessed by goniometer before and 24 hours of KT application.
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.
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.
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.
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.
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.
American Shoulder and Elbow Surgery score was evaluated before and 24 hours of KT application.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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