Effects of Sterile Kinesio Tape on Anterior Cruciate Ligament Reconstruction

NCT04873921 | Completed

• 1 other identifier: KA 21/133
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Edema

Keywords

Kinesiotape; Anterior Cruciate Ligament Reconstruction; Edema; Pain; Range of Motion

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Group 1: Sterile Kinesio tape application

EXPERIMENTAL

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

Group 2: Control group

NO INTERVENTION

Group 2 will not receive any taping

Interventions

sterile kinesio taping OTHER

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.

Also known as: taping

Group 1: Sterile Kinesio tape application

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients who underwent anterior cruciate ligament reconstruction

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, 06790, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Edema; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Group 1 and 2 will be assessed and treated by two different experienced physiotherapists for each group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Proffesor

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: March 1, 2021
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

TU (1)