- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06425913
Effects of Cold and Kinesio Taping in Individuals With Rotator Cuff Tendonitis
May 21, 2024 updated by: Elif Durgut, Bezmialem Vakif University
Short-Term Effects of Cold Therapy and Kinesio Taping on Pain and Upper Extremity Functionality in Individuals With Rotator Cuff Tendonitis: A Randomized Study
Rotator cuff tendonitis (RCT) is one of the most common shoulder pathologies, causing pain, limitation of shoulder joint movements, and impaired function.
Patient education, medical treatment, corticosteroid injections, physiotherapy rehabilitation approaches are the most common treatment options applied to alleviate the symptoms of RCT.
Despite these various treatment methods, there are currently no specific guidelines regarding the most appropriate and effective intervention for RCT treatment.
This is mainly because adequate, high-quality studies are lacking in RCT management.
To the best of our knowledge, no studies have evaluated the effects of Kinesio Taping (KT), which has become a popular approach in recent years, and Cold Therapy (CT), which has often been used as a therapeutic agent since immemorial, on individuals with RCT.
In this regard, this study aimed to investigate and compare the short-term effects of KT and CT on pain and upper extremity functionality in individuals with RCT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- 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
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Istanbul, Turkey, 34060
- Bezmialem Vakıf University
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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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- RCT diagnosis
- Excluding other shoulder pathologies by magnetic resonance imaging (MRI) and specific tests
Exclusion Criteria:
- Glenohumeral joint dislocation/subluxation;
- Acromioclavicular sprain;
- Rotator cuff tear;
- Glenohumeral joint instability;
- Calcific tendinitis of the shoulder;
- Acromioclavicular joint pathologies,
- Hyperlaxity;
- Any fracture in the shoulder;
- Diabetes, thyroid and any vascular or rheumatologic disease;
- Glenohumeral joint deformities;
- Superior labrum anteroposterior (SLAP) lesion;
- Shoulder pain lasting more than six months;
- History of shoulder surgery;
- Intra-articular steroid injection
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Kinesio Taping
KT was applied to the symptomatic shoulder of participants.
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KT was applied to the symptomatic shoulder at the end of the baseline assessment by a certificated physiotherapist with over ten years of experience in Kinesio taping.
After three days, participants were re-evaluated.
KT application has been made according to the protocol for rotator cuff impingement or tendonitis including inhibition and correction techniques.
All participants performed standardized home exercise program, including shoulder isometric and stretching exercises were .
A physiotherapist taught the exercise program until the participants were able to exercise accurately on their own.
All participants were instructed to perform the exercises three times a day for three days.
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Active Comparator: Cold Therapy
Ice packs were applied to the symptomatic shoulder of participants.
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All participants performed standardized home exercise program, including shoulder isometric and stretching exercises were .
A physiotherapist taught the exercise program until the participants were able to exercise accurately on their own.
All participants were instructed to perform the exercises three times a day for three days.
The initial application was administered by the physiotherapist.
In a sitting position, a pack was wrapped in a thin towel and placed on the affected shoulder joint, including the painful locations.
During the application, the participant was closely observed for discomfort or adverse reactions (redness, burning, numbness, itching, …).
The cold application was continued for 20 minutes.After the first application, participants were instructed to apply ice for 20 minutes five times a day for three days at home or work.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: At baseline and after three days of the applications
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Numerical Rating Scale (NRS): The pain severity was assessed using the NRS, for which a subject was asked to rate his/her perceived pain.
A 11-point NRS from 0 to 10 which 0 means no pain and 10 means the worst possible pain was scored during night, rest, and activity.
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At baseline and after three days of the applications
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Function
Time Frame: At baseline and after three days of the applications
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Disability of the Arm, Shoulder and Hand (DASH) Questionnaire): DASH is a self-reported questionnaire designed for evaluating the functional level of upper extremity.
It is a 30-item scale that addresses difficulty in performing various physical activities that require upper extremity function (physical function, 21 items); symptoms of pain, activity-related pain, tingling, weakness, and stiffness (pain symptoms, 5 items); or impact of disability and symptoms on social activities, work, sleep, and psychological well-being (emotional and social function, 4 items).
Each item is scored between 1 and 5.
A score of 1 indicates no strain, and a score of 5 indicates inability to perform the specified activity.
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At baseline and after three days of the applications
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Function
Time Frame: At baseline and after three days of the applications
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Shoulder Pain and Disability Index (SPADI): The SPADI is a self-administered questionnaire developed to measure the pain and disability associated with shoulder pathology in people with shoulder pain of musculoskeletal, neurogenic, or undetermined origin.
It consists of 13 items that assess two domains: a 5-item subscale that measures pain and an 8-item subscale that measures disability.
The items of both domains were scored on a numerical rating scale ranging from 0 to 10, where 0=no pain/no disability and 10= worst pain imaginable/so difficult required help.
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At baseline and after three days of the applications
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of Motion
Time Frame: At baseline and after three days of the applications
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Range of Motion (ROM): The active range of motion (ROM) of the affected shoulder, including flexion, abduction, external rotation, and internal rotation, was assessed using a universal goniometer following the protocol reported by the American Academy of Orthopaedic Surgeons (AAOS)
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At baseline and after three days of the applications
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Grip strength
Time Frame: At baseline and after three days of the applications
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Jamar® hydraulic hand dynamometer were used to assess hand-grip strength of the affected side.
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At baseline and after three days of the applications
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
June 1, 2021
Primary Completion (Actual)
February 26, 2023
Study Completion (Actual)
February 28, 2023
Study Registration Dates
First Submitted
May 16, 2024
First Submitted That Met QC Criteria
May 21, 2024
First Posted (Actual)
May 23, 2024
Study Record Updates
Last Update Posted (Actual)
May 23, 2024
Last Update Submitted That Met QC Criteria
May 21, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 71306642
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will not be shared
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.
Clinical Trials on Rotator Cuff Tendinitis
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GCS Ramsay Santé pour l'Enseignement et la RechercheRecruitingShoulder Rotator Cuff TendinitisFrance
-
InGeneron, Inc.Active, not recruitingRotator Cuff Tear | Rotator Cuff TendinitisUnited States
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Michael KhazzamTerminatedRotator Cuff Tendinitis | Full Thickness Rotator Cuff TearUnited States
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University of California, DavisCompletedRotator Cuff TendonitisUnited States
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Milton S. Hershey Medical CenterWithdrawnDiabetes Mellitus | Rotator Cuff Tear | Rotator Cuff Tendinitis | Rotator Cuff InjuryUnited States
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Xiali XueNot yet recruitingRotator Cuff Tendinitis | Rotator Cuff Tendinosis
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Michael KhazzamNot yet recruitingRotator Cuff Tendinitis | Full-thickness Rotator Cuff TearUnited States
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Northwell HealthRecruitingRotator Cuff Tears | Rotator Cuff Tendinitis | Injections | Glucocorticoids | Rotator Cuff ImpingementUnited States
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