Rotator Cuff TendinosisNCT05029544
Dynamic Taping in Symptomatic Rotator Cuff Tendinopathy
A study testing Dynamic taping, Kinesio taping and Physiotherapy and Rehabilitation in people with Rotator Cuff Tendinosis, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tendinosis
- What is being tested?
- Dynamic taping, Kinesio taping and Physiotherapy and Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 18 Aug 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rotator Cuff Tendinosis
- Being tested
- Dynamic taping, Kinesio taping, Physiotherapy and Rehabilitation
- Keywords
- Rotatory cuff tendinopathy, Acromiohumeral distance, Dynamic taping, Kinesiotaping, Proprioception, Shoulder pain, Rehabilitation
- 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.
Dynamic tapingOther
The intervention of this experimental study was therapeutic taping (dynamic tape) on the symptomatic shoulders of the participants.
Kinesio tapingOther
The intervention of this experimental study was therapeutic taping (kinesio tape) on the symptomatic shoulders of the participants.
Physiotherapy and RehabilitationOther
exercise, manuel therapy, mobilization, massage, sensorimotor control
| Study group | Role | What they receive |
|---|---|---|
| intervention group 1 | Active comparator | dynamic taping and standard rehabilitation program Receives: Other: Dynamic taping; Other: Physiotherapy and Rehabilitation |
| intervention group 2 | Active comparator | Kinesio taping and standard rehabilitation program Receives: Other: Kinesio taping; Other: Physiotherapy and Rehabilitation |
| Control group | Other | No taping on shoulder, only standard rehabilitation program Receives: Other: Physiotherapy and Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acromiohumeral Distance (AHD)
Measurement of the distance between the humeral head and the inferior acromion by ultrasound to determine the subacromial space
Measured: Change in acromiohumeral distance at 6 week
Secondary outcomes (7)
Proprioception
Measurement with digital inclinometer with active reposition repetition method in shoulder flexion of 30 and 60 degrees
Measured: Change in proprioception at 6 week
Muscle Strength
shoulder muscle strength measurement (flexion, abduction, internal and external rotation) with a manual dynamometer
Measured: Change in shoulder muscle strength at 6 week
Shoulder Range of Motion
Shoulder range of motion (painless and full) measurement (flexion, abduction, internal and external rotation)
Measured: Change in shoulder range of motion at 6 week
Lateral Scapular Slide Test
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.
Measured: Change in scapular position at 6 week
Timed Functional Arm and Shoulder Test
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.
Measured: Change in shoulder function at 6 week
The Disabilities of the Arm, Shoulder and Hand (DASH)
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).
Measured: Change in DASH scores at 6 week
Western Ontario Rotator Cuff (WORC) Index
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).
Measured: Change in WORC scores at 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start1 Mar 2021
- Primary completion12 Jun 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinosisStudies 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
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Koc, Muğla Sıtkı Koçman University
- Investigators
- Kılıçhan Bayar, Prof, Study chair, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029544
- Sponsor's protocol ID
- interventional
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05029544
- Acronym / sponsor ID
- interventional
- Conditions
- Rotator Cuff Tendinosis
- Keywords
- Rotatory cuff tendinopathy, Acromiohumeral distance, Dynamic taping, Kinesiotaping, Proprioception, Shoulder pain, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 31 Aug 2021 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intervention group 1 | Active comparator | Other: Dynamic taping, Other: Physiotherapy and Rehabilitationdynamic taping and standard rehabilitation program |
| intervention group 2 | Active comparator | Other: Kinesio taping, Other: Physiotherapy and RehabilitationKinesio taping and standard rehabilitation program |
| Control group | Other | Other: Physiotherapy and RehabilitationNo taping on shoulder, only standard rehabilitation program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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%)
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 |
|---|---|---|
| Dynamic tapingThe intervention of this experimental study was therapeutic taping (dynamic tape) on the symptomatic shoulders of the participants. | Other | intervention group 1 |
| Kinesio tapingThe intervention of this experimental study was therapeutic taping (kinesio tape) on the symptomatic shoulders of the participants. | Other | intervention group 2 |
| Physiotherapy and Rehabilitationexercise, manuel therapy, mobilization, massage, sensorimotor control | Other | Control group, intervention group 1, intervention group 2 |
Primary outcome
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
7 secondary outcomes
Proprioception
Time frame: Change in proprioception at 6 week
Muscle Strength
Time frame: Change in shoulder muscle strength at 6 week
Shoulder Range of Motion
Time frame: Change in shoulder range of motion at 6 week
Lateral Scapular Slide Test
Time frame: Change in scapular position at 6 week
Timed Functional Arm and Shoulder Test
Time frame: 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
Western Ontario Rotator Cuff (WORC) Index
Time frame: Change in WORC scores at 6 week
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 31 Aug 2021.
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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.
Kılıçhan Bayar, Prof study chair
Muğla Sıtkı Koçman 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 Dynamic taping, Kinesio taping and Physiotherapy and Rehabilitation in people with Rotator Cuff Tendinosis, run by Muğla Sıtkı Koçman 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 4 inclusion and 11 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 31 Aug 2021. 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?
Acromiohumeral Distance (AHD) (time frame: Change in acromiohumeral distance at 6 week). 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 31 Aug 2021.