- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06684145
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
60
Phase
- 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
-
-
Elazig
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
|
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
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
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
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)
March 10, 2024
Primary Completion (Actual)
July 20, 2024
Study Completion (Actual)
September 20, 2024
Study Registration Dates
First Submitted
November 8, 2024
First Submitted That Met QC Criteria
November 11, 2024
First Posted (Estimated)
November 12, 2024
Study Record Updates
Last Update Posted (Estimated)
November 12, 2024
Last Update Submitted That Met QC Criteria
November 11, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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