The Effect Of Kinesiotape Application In Chronic Low Back Pain

November 11, 2024 updated by: Muhammet Sahin Elbasti, Firat University

The Effect Of Kinesiotape Application On Clinical Parameters In Postmenopausal Women With Chronic Low Back Pain: A Randomized Controlled Study

This study was conducted to determine the effects of kinesiotaping (KT) and sham KT applied with exercise program on clinical parameters such as pain, sleep, and quality of life in postmenopausal women with chronic low back pain. A randomized controlled experimental design, characteristic of quantitative research, was utilized. The subjects consisted of 60 postmenopausal women. The Visual Analog Scale (VAS), Roland Morris Disability Questionnaire (RMDQ) and Pittsburgh Sleep Quality Index (PSQI) were used as data collection tools.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

With rising life expectancy, women are expected to spend a third of their lives in the postmenopausal stage. Consequently, focusing research on postmenopausal women is considered crucial. This study was conducted to determine the effects of kinesiotaping (KT) and sham KT applied with exercise program on clinical parameters such as pain, sleep, and quality of life in postmenopausal women with chronic low back pain. A randomized controlled experimental design, characteristic of quantitative research, was utilized. The subjects consisted of 60 postmenopausal women. The Visual Analog Scale (VAS), Roland Morris Disability Questionnaire (RMDQ) and Pittsburgh Sleep Quality Index (PSQI) were used as data collection tools.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Elazig
      • Elazığ, Elazig, Turkey, 23119
        • Muhammet Şahin Elbastı

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Postmenopausal patients with chronic nonspecific mechanical low back pain for at least three months
  • VAS score of at least 3

Exclusion Criteria:

  • Patients with a neurologic deficit, history of lumbar surgery, inflammatory low back pain, spinal stenosis, spondylolisthesis, a history of cardiopulmonary disease preventing exercise, severe osteoporosis, or a skin infection in the application area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Kinesiotape application
Kinesiotape application will be performed by a certified researcher using 5cm x 5cm kinesiotape material. In addition to the kinesiotape application, patients will be given a 30-day home exercise program. This consists of passive lumbar flexion (single and double leg stretching), hamstring stretching, pelvic tilt, half sit-up, bridge, straight leg raises, and hip and back extensor strengthening exercises.
Other: Kinesiotape application
Kinesiotape application will be performed by a certified researcher using 5cm x 5cm kinesiotape material. The standing patient, prepared in terms of clothing and skin, will be asked to lean forward. While adhering the tape to the right paravertebral region, the lower end of the tape will be adhered 7 cm below the sacroiliac joint at the level of the paravertebral muscles. The patient, still leaning forward, will be then asked to make a slight rotation to the left; in this position, the tape will be adhered upwards on the paravertebral muscles without any tension. For the left paravertebral region, the procedure will be reversed as compared to the right, ensuring that the tape was not stretched at all.
Other: Control group
Exercise program will be performed to the control group
Other: Exercise
Patients will be given a 30-day home exercise program. This consists of passive lumbar flexion (single and double leg stretching), hamstring stretching, pelvic tilt, half sit-up, bridge, straight leg raises, and hip and back extensor strengthening exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS)
Time Frame: up to 48 hours
VAS is used to subjectively measure perceived pain. It is a scale in the form of a 0-10 cm ruler, with 'no pain' at one end and 'the most severe pain' at the other, used to quantify pain intensity. The patient marks their pain level on the ruler.
up to 48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pittsburgh sleep quality index
Time Frame: up to 48 hours
Turkish reliability and validity study conducted by Ağargün et al. (1996) this scale, which assesses an individual's sleep quality over the past month, includes 24 items. Of these, 19 are self-reported questions answered by the individual, and five are answered by the roommate or spouse
up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Firat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 163

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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