- 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective, randomized controlled trial was designed to evaluate the effects of adding postoperative Kinesio Taping (KT) to a standardized rehabilitation program on pain, edema, shoulder range of motion, and functional recovery after arthroscopic rotator cuff repair.
Patients aged 40-70 years who underwent arthroscopic repair of an isolated full-thickness supraspinatus tear measuring 1-3 cm in the mediolateral dimension were eligible for inclusion. Tear size was confirmed intraoperatively using a calibrated arthroscopic probe. Only tears with Patte grade I-II tendon retraction and Goutallier grade 2 or lower fatty degeneration were included.
Patients with massive or multiple-tendon rotator cuff tears, subscapularis involvement, previous surgery on the affected shoulder, glenohumeral arthritis, systemic inflammatory disease, diabetes mellitus, smoking history, or a known allergy to adhesive or kinesiology tape were excluded.
After providing written informed consent, eligible participants were randomly assigned to one of two treatment groups using a computer-generated block randomization sequence with variable block sizes. Allocation concealment was maintained using sequentially numbered, sealed, opaque envelopes.
Participants in the intervention group received KT in addition to the standardized postoperative rehabilitation program. KT was initiated on postoperative day 1 and reapplied every three days during the first four postoperative weeks, with each application maintained continuously for approximately 72 hours. Participants in the control group followed the same standardized postoperative rehabilitation program without taping. All KT applications were performed by the same certified physiotherapist using a standardized technique.
Because of the visible nature of the intervention, participants and outcome assessors were not blinded to group allocation. However, the assessors were not involved in generating the randomization sequence or concealing treatment allocation.
The primary outcome was postoperative pain intensity measured using the Visual Analog Scale (VAS). Secondary outcomes included shoulder forward flexion and abduction, postoperative edema, shoulder function measured using the Constant-Murley Score, upper-extremity disability measured using the QuickDASH questionnaire, and postoperative complications, including tape-related skin reactions.
Postoperative edema was assessed by measuring the circumference of the operated shoulder at a standardized point in the deltoid region and comparing it with the contralateral shoulder. Shoulder range of motion was measured using a standard goniometer. Each range-of-motion measurement was repeated three times, and the mean value was recorded.
Clinical assessments were performed preoperatively and on postoperative day 1, week 2, week 6, and month 3. Outcomes were compared between the two groups and evaluated longitudinally to determine whether the addition of KT influenced the pattern of early postoperative recovery following arthroscopic rotator cuff repair.
Study Type
Enrollment (Actual)
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: None (Open Label)
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.
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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.
|
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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.
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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, week 2, week 6, 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, week 2, week 6, and month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Range of Motion
Time Frame: Postoperative day 1, week 2, week 6, 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, week 2, week 6, and month 3
|
|
Postoperative Edema Assessed by Relative Shoulder Circumference
Time Frame: Postoperative day 1, week 2, week 6, and month 3
|
Postoperative edema was assessed circumferentially using a non-elastic measuring tape at a standardized point corresponding to the midpoint of the deltoid region.
The contralateral shoulder served as the reference.
Relative edema was expressed as a percentage and calculated as: [(operated-side circumference - contralateral-side circumference) / contralateral-side circumference] × 100.
A value of 0% indicated equal circumference between shoulders.
Higher positive values indicated greater postoperative edema and a worse outcome, whereas values closer to 0% indicated less edema and a better outcome.
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Postoperative day 1, week 2, week 6, and month 3
|
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Shoulder Function (Constant-Murley Score)
Time Frame: Postoperative day 1, week 2, week 6, and month 3
|
Shoulder function was assessed using the Constant-Murley Score, which evaluates pain (0-15 points), activities of daily living (0-20 points), range of motion (0-40 points), and strength (0-25 points).
The total score ranges from 0 to 100 points.
Higher scores indicate better shoulder function and therefore a better outcome, whereas lower scores indicate greater impairment and a worse outcome.
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Postoperative day 1, week 2, week 6, and month 3
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Upper Extremity Function (QuickDASH Score)
Time Frame: Postoperative day 1, week 2, week 6, and month 3
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Upper extremity function and disability will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
The QuickDASH score ranges from 0 to 100, with higher scores indicating greater upper extremity disability and therefore worse functional outcome.
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Postoperative day 1, week 2, week 6, and month 3
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Postoperative Complications
Time Frame: From the date of surgery through postoperative month 3
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Postoperative complications, including wound problems, infection, clinically important shoulder stiffness, repair-related complications, and tape-related skin reactions, will be recorded.
The outcome will be reported as the number and percentage of participants who experience one or more postoperative complications.
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From the date of surgery through postoperative month 3
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
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