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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05888051
Other study ID # E-10840098-772.02-2998
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 3, 2023
Est. completion date March 26, 2024

Study information

Verified date March 2024
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Low back pain is one of the common problems that 80% of people experience at least once in their lifetime. Between 60% and 90% of the adult population are at risk for low back pain at some point in their lives. While most resolve within six weeks, relapses are common. Pain that lasts longer than 12 weeks is defined as chronic pain, and causes significant limitation in daily life and a high psychosocial burden due to pain. Chronic low back pain significantly limits occupational activities due to a decrease in functional status.


Description:

Although chronic low back pain is a problem locally related to the lumbar and sacroiliac joints, it is also affected by changes in the joint and muscle structure of the lower extremity or affects these structures biomechanically. It has been shown that the endurance of the gluteus maximus muscle and the flexibility of the knee and hip flexors are decreased in individuals with chronic low back pain. Studies investigating knee extensor muscle strength in individuals with low back pain in the literature have shown that the maximum voluntary contraction of the knee extensors and the isokinetic strength of the knee extensors are decreased.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date March 26, 2024
Est. primary completion date October 3, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion criteria; - Being between the ages of 18 - 65, - Volunteer. Exclusion criteria; - Having a musculoskeletal or neuromuscular disease that limits mobility, - Presence of lower extremity sequelae, - Having undergone surgery on the Lumbar Region, having a history of systemic, inflammatory or cancer - Participants of both genders will be included in the study.

Study Design


Related Conditions & MeSH terms


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, 

References & Publications (1)

Kim DH, Kim TH. Comparison of the effects of stability exercise and balance exercise on muscle activity in female patients with chronic low back pain. J Exerc Rehabil. 2018 Dec 27;14(6):1053-1058. doi: 10.12965/jer.1836438.219. eCollection 2018 Dec. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale The most basic symptom seen in knee osteoarthritis is pain. As pain is a subjective sensation, it is often difficult to assess. Visual Analogue Scale, pain level, right and left extremities were evaluated separately. In addition, three different measurements were taken as rest, activity and night. For individuals, a value of 0 was "no pain"; A value of 10 was defined as "unbearably severe pain". The point marked by the patient was measured with a tape measure, and the examined value was recorded. Pain assessment was collected under three headings: at rest, during activity, and at night. one day
Primary Lower Extremity Muscle Strength In the measurement of lower extremity muscle strength, Quadriceps and Hamstring muscle strength will be measured with an isokinetic dynamometer (CSMI-Cybex Humac-Norm Testing & Rehabilitation System). The knee extension test will be performed in a sitting position. The test foot will be secured with a Velcro strap by placing it on the dynamometer arm 1 inch above the ankle. The lateral epicondyle of the femur will be used as the anatomical reference with which the axis of the dynamometer is aligned. Two different speeds of maximal reciprocal concentric isokinetic knee extension and flexion; It will be measured as slow (60°/s, 5 reps, 10 sec. rest) and fast (180°/s, 15 reps, 10 sec. rest). one day
Primary Balance Postural stability and joint movements decrease in patients with low back pain. The proper functioning of the musculoskeletal system is necessary to maintain postural control. In our study, we planned to evaluate the static and dynamic balance of the patients with the 'Biodex Balance System S.D.' balance and test device. This device; It is a device used to measure the stability limits of individuals, examining their balance abilities while trying to control and move the center of gravity on the support surface. This system has a mobile balance platform that can tilt its surface up to 20° in 360° range of motion. In this moving platform, 1 indicates the least stable level and 12 indicates the most stable level. This platform is linked to a computer software that allows the balance to be evaluated objectively. one day
Primary Disability The Oswestry Disability Index is a commonly used outcome measure to detect perceived disability in patients with low back pain. This index consists of 10 items, 8 of which are related to activities of daily living and 2 are related to pain. Each item is scored from 0 to 5, and the total score is expressed as a percentage, with higher scores corresponding to more disability). Increasing scores on the Oswestry Disability Index indicate a higher level of disability. one day
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