Kinesio Taping in Patients After Lumbar Disc Surgery

Post Operative Pain Clinical Trial

Official title:

The Effect of Kinesio Taping on Pain and Functionality in the Rehabilitation Process After Lumbar Disc Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05476718
• Other study ID #: Gülsah
• Status: Completed
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: November 2023
• Source: Mersin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, it will be determined whether Kinesio-tape is an effective and reliable application in reducing pain and maintaining functionality after lumbar disc surgery, and its effect on the rehabilitation process will be evaluated.

Description:

According to the 2019 Global Burden of Disease Survey published by the World Health Organization, the problems that contribute most to disability at the global level are musculoskeletal problems. Approximately 1.71 billion people in the world have musculoskeletal diseases (MSD), and low back pain is among the leading causes of disability in 160 countries. According to Turkey's 2019 Global Burden of Disease results, low back pain ranks first among the top ten causes of life years lost due to disability.

Low back pain is also the most common symptom of lumbar disc herniation. Pharmacological, non-pharmacological, and surgical treatment methods can be applied according to the nature of the damage in lumbar disc herniation. Mild to moderate back and leg pain, disability, limitation of function, and decrease in work performance are among the most common problems encountered by patients after surgical intervention for lumbar disc herniation. It is important to reduce low back pain and increase functionality after surgery. Numerous treatments have been researched for low back pain. Kinesio-tape application is gaining popularity around the world and has recently been seen as a preferred option for low back pain.

Kinesio-tape is a rehabilitation technique, designed to facilitate the natural healing process after trauma/inflammation by providing stability and support to muscles and joints. In recent years, its use has been increasing in musculoskeletal problems, neurological, rheumatic, vascular, and lymphatic problems. The Kinesio-tape is easy to apply, it can stay on the skin for a week; It is thought that it can be easily used by patients because it does not require constant effort and time, as in other physical therapy methods such as exercise. Although it has been suggested that Kinesio taping can be used together with traditional analgesic methods to reduce low back pain, no research has been found on the use of Kinesio tape after lumbar disc surgery. This study, it was aimed to determine whether Kinesio-taping is an effective and safe application in reducing post-operative lumbar pain and preserving functionality and to evaluate its effect on the rehabilitation process.

The study, planned as a randomized controlled experimental study, will be conducted with 80 patients (40 Kinesio and 40 placebo groups) who underwent lumbar disc surgery between 25 july 2022-30 december, 2022. Data will be collected with Introductory Information Form, Visual Comparison Scale, Oswestry Disability Index, Functional Low Back Pain Scale, Medication Tracking Form, Tape Tracking Form, Gait Tracking Form, "Healing Process After Lumbar Hernia Surgery".

The taping process will be done by the researcher Gülşah Bilgin, who has attended the course after receiving training on this subject.

All participants in the study will be informed about the study on the first day of their hospitalization, and the Introductory Information Form, Visual Comparison Scale, and Oswestry Disability Index will be filled by the patients, and the researcher will assist the patients who are illiterate or have difficulty in understanding the questions. 24 hours after the operation, a brochure will be given to the patients and their relatives, included in the study by the sampling inclusion and exclusion criteria, to provide a 20-minute education and reminder about the use of a pedometer and home care during the rehabilitation process after herniated disc surgery. Visual Analogue Scale, Oswestry Disability Index, and Functional Low Back Pain Scale for the first follow-up will be filled and all medications taken by the patient, including analgesics, will be recorded on the Medication Tracking Form.

During the treatment and follow-up periods, the use of drugs will not be restricted and they will be asked to record the drugs used. The individuals participating in the study will not be informed about which group they belong to. After the Kinesio/placebo tape application, the patients and their relatives will be shown how to fill out the Medication Follow-up Form and the Walking Follow-up Form.

It is designed by the nurse to facilitate the natural healing process after trauma/inflammation by providing stability and support to the muscles and joints in patients who may experience moderate pain, disability and loss of functionality after lumbar disc surgery.

The aim of this study was to examine the efficacy and safety of the kinesio tape to be applied in reducing pain and maintaining functionality.

Tape will be applied to the placebo and kinesio groups four times and for five days each time. In both groups, the application days and durations of the kinesio tape will be the same, only the application method of the tape will differ. The application will be made in the surgical clinic of a public hospital. exercise to work Patients who do not have a disability, who do not have chronic diseases such as neurological problems, respiratory heart failure, diabetes, and who have undergone standard discectomy will participate. Patients who underwent standard discectomy in the first 24 hours post-op were randomized to one of the two groups.

will be made. In the study, band application will be performed 4 times in 30 days and pain and functionality assessment will be made.

Evaluation of the data: Evaluation of the data will be done in the computer environment, and parametric and nonparametric tests will be used according to the number, percentage, mean, median, and normality distribution from introductory statistics. p ≤ 0.05 will be considered statistically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• be between the ages of 18-65,

• Having had standard discectomy surgery in the last 24 hours, and

• To sign the Informed Voluntary Consent Form.

Exclusion Criteria:

• Having had surgery other than standard laminectomy or discectomy surgery in the last 24 hours,

• Complications developed in the early postoperative period (such as severe bleeding, nausea, vomiting, hemiplegia),

• Having undergone spinal surgery before,

• To have applied Kinesio tape treatment,

• To have received corticosteroid treatment in the two weeks before the surgery, Having clinical signs of central or peripheral nervous system disease (such as sensitivity to touch, lack of coordination, pain even in normal activities, memory loss),

• Being pregnant, Being under the age of 18 and over the age of 65,

• Having a neurological or orthopedic problem that may adversely affect the evaluation of exercise capacity, Having been diagnosed with respiratory or heart failure, and Having insulin-dependent diabetes and

• Not signing the Informed Consent Form.

Related Conditions & MeSH terms

• Lumbar Disc Surgery
• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• Kinesio taping
Patients will be informed about the study on the first day of their hospitalization and the Introductory Information Form, Visual Analogue Scale, and Oswestry Disability Index will be filled in by the patients. 24 hours after the operation, 20 minutes of training will be given to the patient and their relatives on the use of a pedometer and home care, and the first tape will be applied. After discharge, the renewal of the bands will be carried out on the postoperative 1th- 5th-10th-15th days when the patients come to the hospital for post-op evaluation. The clinical recovery of the operation area will be done by the investigative physician. In the follow-ups, evaluations will be made with the Visual Analog Scale, Medication Tracking Form, Oswestry Disability Index,Functional Low Back Pain Scale, Kinesio Tracking Form, and Gait Tracking Form.
• placebo taping
Patients will be informed about the study on the first day of their hospitalization and the Introductory Information Form, Visual Analogue Scale, and Oswestry Disability Index will be filled in by the patients. 24 hours after the operation, 20 minutes of training will be given to the patient and their relatives on the use of a pedometer and home care, and the first tape will be applied. After discharge, the renewal of the bands will be carried out on the postoperative 1th-5th-10th-15th days when the patients come to the hospital for post-op evaluation. The clinical recovery of the operation area will be done by the investigative physician. In the follow-ups, evaluations will be made with the Visual Analog Scale, Medication Tracking Form, Oswestry Disability Index,Functional Low Back Pain Scale, Kinesio Tracking Form, and Gait Tracking Form.

Locations

Country	Name	City	State
Turkey	SBÜ Adana Sehir Egitim ve Arastirma Hastanesi	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain on the 10-point Visual Analog Scale at Day 30.	The visual analogue scale is a 10cm ruler that shows "painlessness" at one end and "the most severe pain possible" at the other end. Change= (day 30- Baseline score)	Baseline and Day 1, 5, 10, 15, 30.
Primary	pain - Medication tracking form	All drugs used by the patient will be recorded on the drug form by the researcher at the hospital and by the patient or their relatives after they go home.The average score for painkillers will be evaluated as 2 points for narcotics and 1 point for non-narcotic drugs. The score will be calculated according to the dose taken by the patient, and if the patient has taken narcotic analgesics 2 times a day, the score will be 4 points.An increase in the score will be interpreted as an increase in the level of pain.	from the postoperative period to the 30th day
Secondary	functionality-Oswestry Disability Index at Day 30.	The Oswestry Disability Index is an outcome-based self-assessment scale developed to assess low back pain. According to this index, "0" is the lowest score and "50" is the highest score. The total score is multiplied by two and expressed as a percentage. If the average score to be obtained from the scale is between 0-10 points, it is accepted as "low level disability", and between 11-30 points as "moderate disability". , and 31-50 points "severe injury". A 6-point improvement on the Oswestry scale is considered a "significant effect" in individuals with low back pain.	Baseline and Day 5, 10, 15, 30.
Secondary	functionality-Functional Low Back Pain Scale	The Functional Low Back Pain Scale is a scale that aims to evaluate the functional status and daily activities of the person, changes in functional status such as bending forward, sitting, standing, walking, climbing stairs and driving.is being done.Each item is scored between 0 and 5; Scoring is "0" not possible to do the activity, "5 points" not difficult. The possible score ranges from 0 to 60. The increase in the score shows that the performance activity is not difficult.	Day 1, 5, 10, 15, 30.
Secondary	functionality-Pedometer	Pedometer is a device used to evaluate physical activity performance.The average number of steps per day; The average was calculated by dividing the total number of daily steps between day 1 and day 5 by four.	Day 5, 10, 15, 30.
Secondary	Evaluation of healing at the surgical site-Kinesio follow-up form	In the evaluation of wound healing, the condition of the wound edges according to the days (epithelialization 1 point, open 0 points), bleeding (hemorrhage 1 point not 0 points), tenderness (tenderness 1 point, no 0 points), infection (1 point not present, 0 points) ), color (normal skin color 1 point, redness 01 points, purulent 02 points), edema (1 point, no 0 points), ecchymosis (1 point, no 0 points), fever (1 point, no 0 points). evaluated over. In the evaluation of the side effects of the kinesio tape, it was evaluated according to skin reactions (1 point, 0 point not present), allergic reaction status (1 point, 0 point not present).An increase in the score compared to the baseline will be interpreted as worsening wound healing, while a decrease will be interpreted as improving wound healing.	Day 1, 5, 10, 15, 30.