Effects of Sterile Kinesio Tape on Anterior Cruciate Ligament Reconstruction

Sponsor

Baskent University (Other)

Overall Status

Completed

CT.gov ID

NCT04873921

Collaborator

(none)

Enrollment

Location

Arms

2.5

Actual Duration (Months)

22.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Edema	Other: sterile kinesio taping	N/A

Study Design

Study Type:

Interventional

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.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 :

Mar 1, 2021

Actual Primary Completion Date :

May 15, 2021

Actual Study Completion Date :

May 15, 2021

Arms and Interventions

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 Names: taping
No Intervention: Group 2: Control group Group 2 will not receive any taping

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 Names:

taping

No Intervention: Group 2: Control group

Group 2 will not receive any taping

Outcome Measures

Primary Outcome Measures

Pain Intensity [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
Edema Assessment [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)
Range of motion measurement [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

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Baskent University	Ankara		Turkey	06790

Sponsors and Collaborators

Baskent University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Last Update Posted:

Jun 22, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nihan Ozunlu Pekyavas, Associated Proffesor, Baskent University

Kinesiotape

Anterior Cruciate Ligament Reconstruction

Edema

Pain

Range of Motion

Additional relevant MeSH terms:

Edema

Study Results

No Results Posted as of Jun 22, 2021