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Effects of Sterile Kinesio Tape on Anterior Cruciate Ligament Reconstruction

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ClinicalTrials.gov Identifier: NCT04873921
Recruitment Status : Completed
First Posted : May 5, 2021
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
Nihan Ozunlu Pekyavas, Baskent University

Study Description
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Brief Summary:
Anterior cruciate ligament reconstruction (ACLR) is a surgical tissue graft replacement of the anterior cruciate ligament, located in the knee, to restore its function after an injury. ACLR is used as the gold standard in coping with pain, deformity, and instability for the patients. The most important factors affecting the success of both surgery and postoperative rehabilitation programs are edema, joint movement limitation and pain around the knee in the early postoperative period. If these parameters are managed well in the postoperative period, the quality of life of the patient increases much earlier. In this respect, kinesio taping treatment, which is practical, comfortable, and safe for the patient, is one of the complementary treatment modalities with positive clinical results. No researchers have studied the effects of Sterile Kinesio Tape applied during ACL reconstruction on edema, pain and range of motion in immediate care postoperatively. The purpose of our study İS to assess effects of Sterile Kinesio Tape application on postoperative edema, pain and range of motion after ACLR within 72 hours. Thirty-seven patients who have undergone ACLR will be recruited to our study. Patients will be randomized into 2 groups; Group 1: Sterile Kinesio tape application, Group 2: Control group. All patients will be assessed for pain intensity (with Visual Analog Scale-VAS), edema (with tape measurement) and range of motion (with goniometric measurement-knee flexion/extension). Assessments will be done every day for 3 days (a total of 3 measurements). Group 1 will receive Sterile Kinesio Taping application within 72 hours applied with Sterile Web Cut Kinesio Tape without tension additional to standard during ACLR postoperative care. Group 2 will receive only standard postoperative care.

Condition or disease Intervention/treatment Phase
Postoperative Pain Edema Other: sterile kinesio taping Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized into 2 groups; Group 1: Sterile Kinesio tape application (n=28), Group 2: Control group (n=28). Group 1 will receive Sterile Kinesio Taping application within 72 hours applied with Sterile Web Cut Kinesio Tape without tension additional to standard postoperative care. Group 2 will receive only standard postoperative care.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Group 1 and 2 will be assessed and treated by two different experienced physiotherapists for each group.
Primary Purpose: Treatment
Official Title: Immediate Effects of Sterile Kinesio Tape Applied During Anterior Cruciate Ligament Reconstruction on Edema, Pain and Range of Motion
Actual Study Start Date : March 1, 2021
Actual Primary Completion Date : May 15, 2021
Actual Study Completion Date : May 15, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: Sterile Kinesio tape application
Sterile Kinesio Taping application will be applied with Sterile Web Cut Kinesio Tape (Sterile Kinesio Tex Tape, Alberquerque, USA) without tension.
 Other: sterile kinesio taping
Application area will be cleaned and dried prior to application to increase the adhesiveness of the tape and application will be done by an experienced physiotherapist during ACLR surgery.
Other Name: taping
No Intervention: Group 2: Control group
Group 2 will not receive any taping


Outcome Measures
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Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: 3 days ]
    Pain intensity will be assessed (every day for 3 days) with Visual Analog Scale (VAS). VAS is a 10-cm line with no marks along it, anchored with the words "no pain" on one hand, and "the most severe pain" on the other. Patients will be simply instructed to place a mark along the line at a level representing the intensity of their pain during activity

  2. Edema Assessment [ Time Frame: 3 days ]
    Edema will be assessed (every day for 3 days) with circumferential measurements in centimeters using basic tape measurement for ACLR knees at 5 levels: incision level, upper part of incision (5 cm above and 10 cm above) and lower part of incision (5 cm below and 10 cm below)

  3. Range of motion measurement [ Time Frame: 3 days ]
    Range of motion measurement will be done (every day for 3 days) with universal goniometry for knee flexion and extension. Knee flexion and extension movements will be measured in the supine position for both knees. The measurements will be recorded in degrees


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients who underwent anterior cruciate ligament reconstruction

Exclusion Criteria:

  • with soft tissue or bone problems affecting the hip or ankle
  • who any neurologic problems,
  • who had any systematic rheumatic problems,
  • had scoliosis,
  • who had undergone orthopedic surgery before,
  • who were obese (BMI> 30 kg/m2)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04873921


Locations
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Turkey
Baskent University
Ankara, Turkey, 06790
Sponsors and Collaborators
Baskent University
More Information
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Responsible Party: Nihan Ozunlu Pekyavas, Associated Proffesor, Baskent University
ClinicalTrials.gov Identifier: NCT04873921    
Other Study ID Numbers: KA 21/133
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nihan Ozunlu Pekyavas, Baskent University:
Kinesiotape
Anterior Cruciate Ligament Reconstruction
Edema
Pain
Range of Motion
Additional relevant MeSH terms:
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Edema