Effects of Sterile Kinesio Tape on Anterior Cruciate Ligament Reconstruction

Postoperative Pain Clinical Trial

Official title:

Immediate Effects of Sterile Kinesio Tape Applied During Anterior Cruciate Ligament Reconstruction on Edema, Pain and Range of Motion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873921
• Other study ID #: KA 21/133
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 15, 2021

Study information

• Verified date: June 2021
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Edema
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
Turkey	Baskent University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 days
Primary	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)	3 days
Primary	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	3 days