Clinical trial NCT05476718: Kinesio Taping in Patients After Lumbar Disc Surgery
Official title: The Effect of Kinesio Taping on Pain and Functionality in the Rehabilitation Process After Lumbar Disc Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Surgery
Post Operative Pain
Keywords: Lumbar Disc Surgery
Post Operative Pain
Functionality
Rehabilitation
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, which was designed as a randomized controlled study (pretest-posttest control group design), Kinesio and placebo groups were formed as the experimental and control groups.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in pain on the 10-point Visual Analog Scale at Day 30.
timeFrame: Baseline and Day 1, 5, 10, 15, 30.
measure: pain - Medication tracking form
timeFrame: from the postoperative period to the 30th day
Secondary outcomes:
measure: functionality-Oswestry Disability Index at Day 30.
timeFrame: Baseline and Day 5, 10, 15, 30.
measure: functionality-Functional Low Back Pain Scale
timeFrame: Day 1, 5, 10, 15, 30.
measure: functionality-Pedometer
timeFrame: Day 5, 10, 15, 30.
measure: Evaluation of healing at the surgical site-Kinesio follow-up form
timeFrame: Day 1, 5, 10, 15, 30.
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: SBÜ Adana Şehir Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Mersin University
name: Emine Öncü, pHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Adana Şehir Hastanesi
name: Melih Çekinmez, pHD
role: PRINCIPAL_INVESTIGATOR
References: