- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07375927
Effect of Kinesio Taping After Rotator Cuff Surgery (RCR-KT)
A Randomized Controlled Study Evaluating the Effect of Postoperative Kinesio Taping on Pain and Functional Recovery Following Arthroscopic Rotator Cuff Repair
The aim of this study is to evaluate whether postoperative kinesio taping provides additional benefits in pain reduction and functional recovery in patients who have undergone arthroscopic rotator cuff repair.
Patients diagnosed with rotator cuff tear who have undergone surgical treatment will be randomly assigned into two groups. One group will receive standard postoperative rehabilitation together with kinesio taping applied for three weeks, while the control group will receive standard postoperative rehabilitation alone.
Pain levels and shoulder function will be assessed during postoperative follow-up using commonly accepted clinical evaluation scales. The findings of this study are expected to contribute to a better understanding of the role of kinesio taping in the recovery process after rotator cuff surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to evaluate the effect of postoperative kinesio taping on pain levels and functional recovery in patients who have undergone arthroscopic rotator cuff repair.
Patients aged between 18 and 70 years with clinical suspicion of rotator cuff tear on physical examination and a diagnosis established by magnetic resonance imaging, with the tear confirmed intraoperatively, will be included in the study.
After providing written informed consent, eligible patients will be randomly assigned into two groups in a 1:1 ratio using a computer-generated randomization list.
The intervention group will receive standard postoperative rehabilitation combined with kinesio taping applied for three weeks following surgery. The control group will receive standard postoperative rehabilitation alone.
The study is designed as a single-blinded randomized controlled trial. The investigator responsible for postoperative clinical assessments will be blinded to group allocation in order to minimize evaluation bias.
Pain intensity and functional outcomes will be assessed during postoperative follow-up using validated clinical outcome measures, including the Visual Analog Scale (VAS), the Shoulder Pain and Disability Index (SPADI), and the UCLA shoulder score. Shoulder range of motion will also be recorded.
Patients will be evaluated at postoperative day 1, month 1, and month 3. Clinical outcomes will be compared between the two groups, as well as within each group over time, to assess the recovery process after surgery.
The results of this study are expected to provide further insight into the potential role of kinesio taping as an adjunctive method in postoperative rehabilitation following arthroscopic rotator cuff repair.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey (Türkiye), 34785
- Fatih Sultan Mehmet Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged between 18 and 70 years
- Patients with clinical suspicion of rotator cuff tear on physical examination and a diagnosis established by magnetic resonance imaging, with intraoperative confirmation
- Patients with at least two positive impingement tests on physical examination (Jobe, Hawkins-Kennedy, Neer)
- Patients without a diagnosed psychiatric disorder
- Patients without a history or current diagnosis of cervical pathology
- Patients with a Visual Analog Scale (VAS) score of 3 or higher for at least 3 months prior to surgery
- Patients able to participate regularly in postoperative follow-up for a period of one year
- Patients who agree to participate voluntarily and provide written informed consent
Exclusion Criteria:
- History of shoulder dislocation
- History of fracture involving the shoulder or surrounding structures
- Inability to comply with postoperative treatment or attend regular follow-up visits
- Known skin hypersensitivity or allergy to kinesio taping
- Known rheumatologic or neurological disease
- History of previous shoulder or peri-shoulder surgery
- Presence of cervical disc pathology
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinesio Taping Group
Participants in this group will receive standard postoperative rehabilitation following arthroscopic rotator cuff repair, in addition to kinesio taping applied for three weeks during the postoperative period.
|
Application of kinesio taping to the operated shoulder during the postoperative period as an adjunct to standard rehabilitation.
Standard postoperative rehabilitation program following arthroscopic rotator cuff repair.
|
|
Active Comparator: Control Group
Participants in this group will receive standard postoperative rehabilitation alone following arthroscopic rotator cuff repair, without the application of kinesio taping.
|
Standard postoperative rehabilitation program following arthroscopic rotator cuff repair.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity (Visual Analog Scale, VAS)
Time Frame: Postoperative day 1, month 1, and month 3.
|
Pain intensity will be assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain.
Higher scores indicate worse pain intensity.
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Postoperative day 1, month 1, and month 3.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Function (SPADI Score)
Time Frame: Postoperative day 1, month 1, and month 3.
|
Shoulder function will be evaluated using the Shoulder Pain and Disability Index (SPADI), a questionnaire ranging from 0 to 100, where higher scores indicate greater pain and disability and therefore worse shoulder function.
|
Postoperative day 1, month 1, and month 3.
|
|
Shoulder Function (UCLA Shoulder Score)
Time Frame: Postoperative day 1, month 1, and month 3.
|
Shoulder function will be assessed using the University of California at Los Angeles (UCLA) Shoulder Score during postoperative follow-up.
The UCLA Shoulder Score ranges from 0 to 35, with higher scores indicating better shoulder function and less pain.
|
Postoperative day 1, month 1, and month 3.
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Shoulder Range of Motion
Time Frame: Postoperative day 1, month 1, and month 3.
|
Active shoulder range of motion will be assessed during postoperative follow-up using goniometric measurements in degrees.
Higher values indicate greater shoulder mobility and better functional outcome.
|
Postoperative day 1, month 1, and month 3.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Shoulder Injuries
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Wounds and Injuries
- Postoperative Complications
- Pathologic Processes
- Joint Diseases
- Rupture
- Tendon Injuries
- Arthralgia
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Rotator Cuff Injuries
- Pain, Postoperative
- Shoulder Pain
Other Study ID Numbers
- RCR-KT-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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