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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06417255
Other study ID # CHRONIC LOW BACK PAIN
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 11, 2024
Est. completion date September 21, 2024

Study information

Verified date May 2024
Source Istanbul Medipol University Hospital
Contact Hazal GENÇ, PhD
Phone 05413204291
Email hazaloksuz@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Low back pain is an important health problem that is common worldwide, with a lifetime prevalence of up to 80%.


Description:

Low back pain that lasts less than 6 weeks is called acute low back pain, if it continues for 6-12 weeks it is called subacute low back pain, and if it continues for more than 12 weeks it is called chronic low back pain. The majority of low back pain (97%) is of mechanical origin.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 21, 2024
Est. primary completion date July 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Patients with chronic low back pain - Individuals aged 18-60 years - Patients without verbal communication barriers - Patients without cognitive impairment (delirium, dementia, amnesia) Exclusion Criteria: - Exercise contraindication (uncontrolled medical conditions) - Patients with previous spinal surgery - Patients who develop an allergic reaction to the kinesiotape tape to be applied

Study Design


Related Conditions & MeSH terms


Intervention

Other:
kinesiotape application
The strips used for kinesiological taping can be applied by giving different shapes. These shapes are I, Y, X, ring (donut), rake and net
foam roller application
In the foam roller group, "Actifoam" brand non-serrated foam rollers with a size of "15x90" cm were used.

Locations

Country Name City State
Turkey Hazal GENÇ Istanbul None Selected

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pressure Pain Measurement with Algometer The algometer, an effective way of measuring pressure pain threshold (PPT), is used to measure soft tissue pain associated with trigger points.
Pittsburgh Sleep Quality Scale The Pittsburgh Sleep Quality Index is the most commonly used general measure in clinical and research settings to assess sleep quality and quantity. The Pittsburgh Sleep Quality Index (PSQI) consists of a total of 19 questions and 7 components to assess sleep quality during the last month. The total score had a value between 0-21
Schober Flexibility Test With the patient standing, the examiner marks the spinous process of the first sacral vertebra and 10 cm above this point. The patient is then asked to flex forwards as if trying to touch their toes while keeping their knees straight. If the distance between the two points does not increase by at least 5 cm, this is considered a sign of restriction in lumbar flexion.
6 weeks
Primary Pittsburgh Sleep Quality Scale The Pittsburgh Sleep Quality Index is the most commonly used general measure in clinical and research settings to assess sleep quality and quantity. The Pittsburgh Sleep Quality Index (PSQI) consists of a total of 19 questions and 7 components to assess sleep quality during the last month. The total score had a value between 0-21 6 weeks
Primary Schober Flexibility Test With the patient standing, the examiner marks the spinous process of the first sacral vertebra and 10 cm above this point. The patient is then asked to flex forwards as if trying to touch their toes while keeping their knees straight. If the distance between the two points does not increase by at least 5 cm, this is considered a sign of restriction in lumbar flexion. 6 weeks
Primary The finger-to-floor distance The finger-to-floor distance test is a test that measures specific physical disability. This test is performed with the person standing upright with feet together. The patient is asked to lean as far forward as possible with knees, arms and fingers fully extended. The vertical distance between the tip of the middle finger and the floor is measured with a flexible tape measure. 6 weeks
Primary Tampa Kinesiophobia Fatigue Scale The Tampa Kinesiophobia Scale measures fear of movement and fear of (re)injury during movement. High fear of movement and/or (re)injury, as measured by the Tampa Kinesiophobia Scale, has been found to be associated with poor performance on a number of physical tests.
The minimum and maximum values of the Tampa Kinesiophobia Fatigue Scale are between 17 and 68. The total score range of this scale is between 0 and 68.
6 weeks
Primary Oswestry Scale The Oswestry Disability Index, first introduced by Fairbank et al. in 1980, is considered close to the gold standard for measuring the severity of disability due to low back pain. The Oswestry scale is a self-administered, free, easy-to-use and easy-to-score questionnaire containing 10 questions on different functional domains.
The Oswestry Disability Index (ODI) is a widely used tool to assess disability related to low back pain. It consists of 10 sections addressing various daily activities, each scored on a scale of 0 to 5. The minimum score is 0, indicating no disability, while the maximum score is 50, indicating severe disability.
6 weeks
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