The Efficacy of Kinesiotaping on Pain, Edema and Functionality After Total Knee Arthroplasty

Sponsor
Kirsehir Ahi Evran Universitesi (Other)
Overall Status
Recruiting
CT.gov ID
NCT05457686
Collaborator
(none)
42
1
3
5.4
7.7

Study Details

Study Description

Brief Summary

In this prospective, randomized controlled trial; To evaluate the effect of kinesiology taping applied for edema on pain, edema and functions in the early period after total knee replacement.Patients who underwent total knee replacement will be included in the 10-day follow-up study.Patients will be divided into three groups by randomization. A conservative postoperative physiotherapy program, which is routinely applied to all groups, will be applied. Thus, no patient will be left without treatment. The first group will be considered as the control group, which will be given only a conservative physiotherapy program.

In addition to the conservative postoperative physiotherapy program, the 2nd group will be taped without applying tension with a plaster and will be considered as the sham group.

In the third group, in addition to the conservative postoperative physiotherapy program, kinesiotaping for payment will be applied.

Condition or Disease Intervention/Treatment Phase
  • Other: kinesio tape
  • Other: Sham taping
  • Other: Exercise
N/A

Detailed Description

Patients will be divided into three groups by randomization. A conservative postoperative physiotherapy program, which is routinely applied to all groups, will be applied. Thus, no patient will be left without treatment. The first group will be considered as the control group, which will be given only a conservative physiotherapy program.

In addition to the conservative postoperative physiotherapy program, the 2nd group will be taped without applying tension with a plaster and will be considered as the sham group.

In the third group, in addition to the conservative postoperative physiotherapy program, kinesiotaping for payment will be applied.

It is planned to prevent bias between the groups by giving standard analgesic treatment to all three groups in the postoperative period. In the postoperative period, Paracetamol 10 mg/ml Infusion 31, 100 mg tramadol hydrochloride tablet 21 and celecoxib capsule 100 mg 2*1 will be routinely administered until the discharge period.

Conservative postoperative physiotherapy program:

Conservative exercise program will be started on the second day after the surgery. All patients will receive an exercise program combined with a 20-minute local cold application once a day. Ankle pumping exercises, deep breathing exercises, isometric knee and hip circumference strengthening exercises, sitting by the bed, timed walking with a tolerable load on the prosthetic side will be recommended.

The number and frequency of exercises were gradually increased; isotonic knee and hip circumference strengthening exercises It will be added. After the drainage of the surgical wound is removed on the 2nd or 3rd day, the patients will be discharged on the 4th postoperative day. All patients will be informed about the conditions and activities that need attention. Patients who continue their home exercise program after discharge will be called for control on the 10th day.

Kinesio taping: In addition to its use in regional pain syndromes in recent years, KT application has also been reported in the literature after various non-orthopedic surgical procedures . Today, after KT application, which is widely used in orthopedics, especially in arthroscopic interventions, no negative effects have been observed on patients, and positive results have been reported, especially in the early period. The investigators aimed to compare this treatment method, which has been shown to be effective in studies performed after total knee arthroplasty, with SHAM taping and conservative postoperative physiotherapy program control group in a prospective randomized comparison.

Kinesiotaping is applied to the sub-knee region in accordance with the lymphatic correction technique in order to reduce edema and pain from the first postoperative day in the group receiving KT treatment.Accordingly, the proximal part of the tape will be placed close to the lymph node.In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching.Then 5-10% stretching is applied and the distal part is adhered.

The strips are applied as 2 separate bands crossing each other (from the medial and lateral of the knee).The patients will be taped with kinesio tape on the first day and the third day postoperatively, and they will be discharged on the fourth day.

After discharge, participant will be asked to remove the bands after 3 days as instructed.

SHAM taping: Sham application will be taped with a plaster from the same area on the same days as the kinesio application. No tension will be applied while taping. The difference of the plaster from the kinesiotape is that it does not contain tension and does not allow stretching.

Kinesiotaping application; It will be done by a physical therapist who has a kinesiology taping course certificate.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled studyrandomized controlled study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Kinesiology Taping After Total Knee Arthroplasty Surgery
Anticipated Study Start Date :
Jul 20, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: kinesiology group

In the group receiving kinesiology treatment, kinesiotaping is applied to the sub-knee region in accordance with the lymphatic correction technique from the first postoperative day to reduce edema and pain. Accordingly, the proximal part of the tape is placed close to the lymph node. In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching. Then 5-10% stretching is applied and the distal part is adhered. 2 separate bands are applied so that the strips cross each other (from the medial and lateral of the knee). On the first postoperative day, on the third day, the patients will be taped with kinesio tape and discharged on the fourth day. After discharge, they will be asked to remove the tapes after 3 days as they were taught.

Other: kinesio tape
According to this, the proximal part of the band is located close to the lymph node. In our study, as stated in the literature, the proximal part of the tape will be adhered to the fibular head area next to the lymph nodes without applying any stretching. Then 5-10% stretching is applied and the distal part is adhered. 2 separate tapes are applied so that the strips cross each other

Other: Exercise
Routine exercise and physiotherapy program applied after knee arthroplasty surgery will be applied

Sham Comparator: sham taping group

Sham application will be taped with a plaster from the same area on the same days as the kinesio application. No tension will be applied while taping. The difference of the plaster from the kinesiotape is that it does not contain tension and does not allow stretching.

Other: Sham taping
In the same procedure and time as kinesiotaping, inelastic tape will be used instead of kinesiotape.

Other: Exercise
Routine exercise and physiotherapy program applied after knee arthroplasty surgery will be applied

Other: only physical therapy group(control group)

Conservative will be explained on the second day after the operation. Go for a visit with a local cold application 20 times once a day. Ankle pumping exercises, deep breathing exercises, isometric and hip exercises will be planned with a load that can be applied to students who are being applied for bed training. Increased the number and allowance of exercises; isotonic knee and exercises that make you feel It will be added. You will be discharged on the 4th day after the surgery on the 2nd or 3rd day. You will do home exercises after discharge. On the 10th day, you will be called for control.

Other: Exercise
Routine exercise and physiotherapy program applied after knee arthroplasty surgery will be applied

Outcome Measures

Primary Outcome Measures

  1. edema [1 day before surgery]

    thigh, knee and leg diameter measurements to be measured with a tape measure

  2. edema [1 days after surgery]

    thigh, knee and leg diameter measurements to be measured with a tape measure

  3. edema [3 days after surgery]

    thigh, knee and leg diameter measurements to be measured with a tape measure

  4. edema [10 days after surgery]

    thigh, knee and leg diameter measurements to be measured with a tape measure

Secondary Outcome Measures

  1. Pain Intensity [1 day before surgery]

    Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

  2. Pain Intensity [1 day after surgery]

    Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

  3. Pain Intensity [3 days after surgery]

    Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

  4. Pain Intensity [10 days after surgery]

    Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.

Other Outcome Measures

  1. Functionality [1 day before surgery]

    Functional assessment: Knee functional assessment will be made using the Oxford Knee Score. The Oxford Knee Score (OKS) was specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is a patient-reported 12-item scale. Each question is scored between 1-5 points from best to severe disability. Turkish validity and reliability has been established.

  2. Functionality [1 day after surgery]

    Functional assessment: Knee functional assessment will be made using the Oxford Knee Score. The Oxford Knee Score (OKS) was specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is a patient-reported 12-item scale. Each question is scored between 1-5 points from best to severe disability. Turkish validity and reliability has been established.

  3. Functionality [3 days after surgery]

    Functional assessment: Knee functional assessment will be made using the Oxford Knee Score. The Oxford Knee Score (OKS) was specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is a patient-reported 12-item scale. Each question is scored between 1-5 points from best to severe disability. Turkish validity and reliability has been established.

  4. Functionality [10 days after surgery]

    Functional assessment: Knee functional assessment will be made using the Oxford Knee Score. The Oxford Knee Score (OKS) was specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is a patient-reported 12-item scale. Each question is scored between 1-5 points from best to severe disability. Turkish validity and reliability has been established.

  5. Measuring knee Joint Range of Motion [1 day before surgery]

    Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.

  6. Measuring knee Joint Range of Motion [1 daysafter surgery]

    Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.

  7. Measuring knee Joint Range of Motion [3 days after surgery]

    Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.

  8. Measuring knee Joint Range of Motion [10 days after surgery]

    Knee joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, knee ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Performing total knee joint arthroplasty due to stage 4 gonarthrosis

  2. Agree to participate in the study

  3. Having signed the informed consent form

Exclusion Criteria:
  1. Presence of malignancy, infection, rheumatological disease

  2. Having a tape allergy

  3. Having a diagnosis of lymphedema

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ahievran university Kirşehi̇r Turkey 40100

Sponsors and Collaborators

  • Kirsehir Ahi Evran Universitesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mehmet Fevzi Cakmak, assistant proffesor, Kirsehir Ahi Evran Universitesi
ClinicalTrials.gov Identifier:
NCT05457686
Other Study ID Numbers:
  • 2022-08/87
First Posted:
Jul 14, 2022
Last Update Posted:
Jul 14, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mehmet Fevzi Cakmak, assistant proffesor, Kirsehir Ahi Evran Universitesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2022