Chronic Low-back Pain (cLBP)NCT06684145
The Effect Of Kinesiotape Application In Chronic Low Back Pain
A study testing Kinesiotape application and Exercise in people with Chronic Low-back Pain (cLBP), run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- Kinesiotape application and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2024to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal patients with chronic nonspecific mechanical low back pain for at least three months
- VAS score of at least 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- Kinesiotape application, Exercise
- Keywords
- Chronic low back pain, Kinesiotape, Sleep quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiotape applicationOther
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.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape application | Experimental | 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. Receives: Other: Kinesiotape application |
| Control group | Other | Exercise program will be performed to the control group Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
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.
Measured: up to 48 hours
Secondary outcomes (1)
Pittsburgh sleep quality index
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
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start10 Mar 2024
- Primary completion20 Jul 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Sahin Elbasti, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684145
- Sponsor's protocol ID
- 163
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Kinesiotape Application On Clinical Parameters In Postmenopausal Women With Chronic Low Back Pain: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06684145
- Acronym / sponsor ID
- 163
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- Chronic low back pain, Kinesiotape, Sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape application | Experimental | Other: Kinesiotape applicationKinesiotape 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. |
| Control group | Other | Other: ExerciseExercise program will be performed to the control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal patients with chronic nonspecific mechanical low back pain for at least three months
- VAS score of at least 3
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesiotape applicationKinesiotape 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 | Kinesiotape application |
| ExercisePatients 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 | Control group |
Primary outcome
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.
1 secondary outcome
Pittsburgh sleep quality index
Time frame: up to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotape application and Exercise in people with Chronic Low-back Pain (cLBP), run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.