Effects of Sterile Kinesio Tape on Anterior Cruciate Ligament Reconstruction
Primary Purpose
Postoperative Pain, Edema
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
sterile kinesio taping
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Kinesiotape, Anterior Cruciate Ligament Reconstruction, Edema, Pain, Range of Motion
Eligibility 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)
Sites / Locations
- Baskent University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group 1: Sterile Kinesio tape application
Group 2: Control group
Arm Description
Sterile Kinesio Taping application will be applied with Sterile Web Cut Kinesio Tape (Sterile Kinesio Tex Tape, Alberquerque, USA) without tension.
Group 2 will not receive any taping
Outcomes
Primary Outcome Measures
Pain Intensity
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
Edema Assessment
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)
Range of motion measurement
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04873921
Brief Title
Effects of Sterile Kinesio Tape on Anterior Cruciate Ligament Reconstruction
Official Title
Immediate Effects of Sterile Kinesio Tape Applied During Anterior Cruciate Ligament Reconstruction on Edema, Pain and Range of Motion
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Edema
Keywords
Kinesiotape, Anterior Cruciate Ligament Reconstruction, Edema, Pain, Range of Motion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Group 1 and 2 will be assessed and treated by two different experienced physiotherapists for each group.
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Sterile Kinesio tape application
Arm Type
Experimental
Arm Description
Sterile Kinesio Taping application will be applied with Sterile Web Cut Kinesio Tape (Sterile Kinesio Tex Tape, Alberquerque, USA) without tension.
Arm Title
Group 2: Control group
Arm Type
No Intervention
Arm Description
Group 2 will not receive any taping
Intervention Type
Other
Intervention Name(s)
sterile kinesio taping
Other Intervention Name(s)
taping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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
Time Frame
3 days
Title
Edema Assessment
Description
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)
Time Frame
3 days
Title
Range of motion measurement
Description
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
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Baskent University
City
Ankara
ZIP/Postal Code
06790
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Sterile Kinesio Tape on Anterior Cruciate Ligament Reconstruction
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