Dynamic Taping in Symptomatic Rotator Cuff Tendinopathy

August 25, 2021 updated by: Meltem Koc, Muğla Sıtkı Koçman University

Comparison of Effects of Kinesio Taping and Dynamic Taping Added to a Rehabilitation Programme for Patients With Symptomatic Rotator Cuff Tendinopathy: A Randomised Controlled Trial

This study was conducted to compare the efficacy of two different therapeutic bands in symptomatic rotator cuff tendinopathy. One of the tapes was kinesio tape and the other was dynamic tape. The study was in a parallel group randomized controlled trial design.

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

This study was planned to compare the effectiveness of dynamic taping and kinesio taping combined with a rehabilitation program on the symptomatic shoulder in patients with symptomatic rotator cuff tendinopathy (RCT). The study was carried out on 60 patients who applied to Muğla Training and Research Hospital Physical Therapy and Rehabilitation outpatient clinic with symptoms of RCT. The patients were divided into 3 groups by randomization method. Dynamic taping was applied to the symptomatic shoulder in the first group and kinesio taping was performed in the second group. The third group was the control group and no taping was done. A standard rehabilitation program was applied for the individuals in the whole group. Evaluations were made before and after treatment (6 weeks). Evaluation parameters were acromiohumeral distance (primary outcome), shoulder joint range of motion, muscle strength, proprioception measurements, and function evaluations. The acromiohumeral distance was measured by the radiologist, and all other measurements and treatments were performed by the physiotherapist. Standard goniometer was used for shoulder joint range of motion measurement, manual muscle dynamometer was used for muscle strength measurement, and digital inclinometer was used for proprioception measurement. Timed arm-shoulder function test was performed for function evaluation. The arm, shoulder, and hand disability (DASH) questionnaire and the Western Ontario Rotator Cuff Index (WORC) were used for the self-function report. The data obtained from the research will be analyzed using the SPSS program. Statistical significance level will be accepted as p<0.05. In the statistical difference analysis between groups, one-way ANOVA test will be used for parametric data and Kruskal-Wallis test will be used for non-parametric data.

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.
60

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Muğla, Turkey
        • Muğla Sıtkı Koçman University

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Those with a diagnosis of RCT
  • Those with subacromial pain
  • At least two of the three impingement tests are positive (empty-can test, Hawkins-Kennedy test, modified Neer test)
  • 18-65 years old

Exclusion Criteria:

  • Those with open wounds at the taping area
  • Those who have allergic reactions to taping
  • Those who have had shoulder surgery before
  • Those with total rotator cuff tendon rupture
  • Those with a history of fractures in the upper extremity or glenohumeral joint subluxation -- Presence of adhesive capsulitis (those with more than passive shoulder joint motion loss 70%)
  • Presence of congenital or acquired deformity involving the upper extremity
  • Those with rheumatic or neurologic disease
  • Those with cervical radiculopathy
  • Those with a history of neoplasm or cognitive impairment (MMSE<24)
  • Those who received corticosteroid injection to the shoulder region in the last 3 months
  • Those who received physiotherapy treatment in the last 3 months

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Active Comparator: intervention group 1
dynamic taping and standard rehabilitation program
Other: Dynamic taping
The intervention of this experimental study was therapeutic taping (dynamic tape) on the symptomatic shoulders of the participants.
Other: Physiotherapy and Rehabilitation
exercise, manuel therapy, mobilization, massage, sensorimotor control
Active Comparator: intervention group 2
Kinesio taping and standard rehabilitation program
Other: Physiotherapy and Rehabilitation
exercise, manuel therapy, mobilization, massage, sensorimotor control
Other: Kinesio taping
The intervention of this experimental study was therapeutic taping (kinesio tape) on the symptomatic shoulders of the participants.
Other: Control group
No taping on shoulder, only standard rehabilitation program
Other: Physiotherapy and Rehabilitation
exercise, manuel therapy, mobilization, massage, sensorimotor control

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
Acromiohumeral Distance (AHD)
Time Frame: Change in acromiohumeral distance at 6 week
Measurement of the distance between the humeral head and the inferior acromion by ultrasound to determine the subacromial space
Change in acromiohumeral distance at 6 week

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
Proprioception
Time Frame: Change in proprioception at 6 week
Measurement with digital inclinometer with active reposition repetition method in shoulder flexion of 30 and 60 degrees
Change in proprioception at 6 week
Muscle Strength
Time Frame: Change in shoulder muscle strength at 6 week
shoulder muscle strength measurement (flexion, abduction, internal and external rotation) with a manual dynamometer
Change in shoulder muscle strength at 6 week
Shoulder Range of Motion
Time Frame: Change in shoulder range of motion at 6 week
Shoulder range of motion (painless and full) measurement (flexion, abduction, internal and external rotation)
Change in shoulder range of motion at 6 week
Lateral Scapular Slide Test
Time Frame: Change in scapular position at 6 week
Background: The Lateral Scapular Slide Test is a static test used in clinical settings to assess medio-lateral inferior angle displacement and scapular asymmetry at three different degrees of shoulder abduction.
Change in scapular position at 6 week
Timed Functional Arm and Shoulder Test
Time Frame: Change in shoulder function at 6 week
The test includes 3 steps. 1) Hand to head and back: this test is timed for 30 seconds. Each time the patient touches the back of his or her head, it counts as 1 repetition. 2) Wall wash outward and inward: this test is timed for 60 seconds in each direction. 3) Gallon-jug lift: this test is timed for 30 seconds. Starting counter height should be 36 inches, and the shelf should be 20 inches above the counter (56 inches off the floor). Begin with a full gallon jug on the counter. Lift the jug to touch the shelf and return to start. Every time the jug touches the shelf, it counts as 1 repetition. Record the score.
Change in shoulder function at 6 week
The Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame: Change in DASH scores at 6 week
DASH questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. In DASH higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score ranges from 0 (no disability) to 100 (most severe disability).
Change in DASH scores at 6 week
Western Ontario Rotator Cuff (WORC) Index
Time Frame: Change in WORC scores at 6 week
the WORC Index, is a disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to a RC tendinopathy. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100. The maximum score (21items) is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. To make the final score more clinically friendly, some minor math is involved. The score can be reported as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This give an overall percentage. Total final WORC scores can, therefore, range from 0% ( lowest functional status level) to 100% (the highest functional status).
Change in WORC scores at 6 week

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.
Muğla Sıtkı Koçman University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Kılıçhan Bayar, Prof, Muğla Sıtkı Koçman 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 (Actual)

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.
March 1, 2021

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.
June 12, 2021

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.
August 18, 2021

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).
August 19, 2021

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.
August 25, 2021

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.
August 31, 2021

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.
August 31, 2021

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.
August 25, 2021

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.
August 1, 2021

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.
  • Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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