NCT05476718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

June 29, 2022

Last Update Submit

November 5, 2023

Conditions

Keywords

Lumbar Disc SurgeryPost Operative PainFunctionalityRehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (4)

  • functionality-Oswestry Disability Index at Day 30.

    Baseline and Day 5, 10, 15, 30.

  • functionality-Functional Low Back Pain Scale

    Day 1, 5, 10, 15, 30.

  • functionality-Pedometer

    Day 5, 10, 15, 30.

  • Evaluation of healing at the surgical site-Kinesio follow-up form

    Day 1, 5, 10, 15, 30.

Study Arms (2)

kinesio group

ACTIVE COMPARATOR

The tape will be applied in the first 24 hours postoperatively and on the 5th, 10th, 15th days of the surgery. The posterior superior iliac spine (PSI) and 12th thoracic vertebra (T12) will be marked while the participant is sitting in a comfortable position. Tape application will be made bilaterally between PSI and T12 with tapes cut in an "I" shape along the erector spine muscles. The anchor and end parts of the tape will be rounded. The anchor part will be glued without tension. Afterward, individuals are asked to flex and rotate their trunks as much as possible, and the middle part of the band is slightly stretched 10-15%; After the spine is brought to its normal anatomical position, the tip will be glued without tension. After sticking, the tape will be manually activated. This transaction will be carried out by both parties. After the tape adheres, individuals will be asked to keep the tape for five days until the next taping.

Other: Kinesio taping

placebo group

PLACEBO COMPARATOR

The tape will be applied in the first 24 hours postoperatively and on the 5th, 10th, 15th days of the surgery. The placebo-tape application will be applied the lumbar region in a tension-free and horizontal form, while the spine is in a neutral position without positioning the patients. After sticking, the tape will be manually activated. After the tape adheres, individuals will be asked to hold the tape for five days until the next taping.

Other: placebo taping

Interventions

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.

kinesio group

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 group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBÜ Adana Şehir Eğitim ve Araştırma Hastanesi

Adana, 01000, Turkey (Türkiye)

Location

Related Publications (1)

  • Bilgin G, Oncu E, Cekinmez M. The Effect of I-Shaped Kinesiotaping on Pain, Functionality, and Wound Healing After Lumbar Disc Surgery: A Randomised Controlled Trial. Biol Res Nurs. 2026 Jan 13:10998004261416820. doi: 10.1177/10998004261416820. Online ahead of print.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Emine Öncü, pHD

    Mersin University

    PRINCIPAL INVESTIGATOR
  • Melih Çekinmez, pHD

    Adana Şehir Hastanesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In a randomized, placebo-controlled experimental trial, the participants and data analyzer will be blinded, and the researcher will be blinded to group assignments. Randomizer org site will be used for random assignment of groups as Kinesio or placebo (httpp://www.random.org/lists/). Index cards prepared by simple randomization by the researcher who did not participate in the clinical part of the study will be placed in closed opaque envelopes and sequence numbers will be written on the envelopes. Envelopes will be retained by the clinical secretary who did not participate in the study. The research data will be entered into the computer database by the researcher as coded as A and B, statistical analyzes will be carried out by the researcher who did not participate in the data collection phase according to this code, and the research report will be written in coded form.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 27, 2022

Study Start

July 25, 2022

Primary Completion

June 30, 2023

Study Completion

July 30, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations