- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05888051
Assessment of Lower Extremity Isokinetic Muscle Strength and Balance in Individuals With Chronic Low Back Pain
March 26, 2024 updated by: hazal genc, Istanbul Medipol University Hospital
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
110
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
-
-
None Selected
-
Istanbul, None Selected, Turkey, 34353
- Hazal GENÇ
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-
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
Sampling Method
Non-Probability Sample
Study Population
Participants; Questions will be asked in total, including information such as age, gender, height, weight, dominant hand.
Description
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 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
Cohorts and Interventions
Group / Cohort |
---|
Young Adult
|
Adult
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: one day
|
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
|
Lower Extremity Muscle Strength
Time Frame: one day
|
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
|
Balance
Time Frame: one day
|
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
|
Disability
Time Frame: one day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
October 3, 2023
Primary Completion (Actual)
October 3, 2023
Study Completion (Actual)
March 26, 2024
Study Registration Dates
First Submitted
May 25, 2023
First Submitted That Met QC Criteria
May 25, 2023
First Posted (Actual)
June 5, 2023
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-2998
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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