Back PainNCT05888051
Age-related Differences on Low Back Pain and Lower Extremity Isokinetic Muscle Strength and Balance
An observational study of Back Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2023to 26 Mar 2024
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants; Questions will be asked in total, including information such as age, gender, height, weight, dominant hand.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Back Pain
- Keywords
- balance
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young Adult | Not described | |
| Adult | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
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).
Measured: one day
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.
Measured: one day
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start3 Oct 2023
- Primary completion3 Oct 2023
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Istanbul Medipol University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888051
- Sponsor's protocol ID
- E-10840098-772.02
- Status last verified
- Nov 2025
- First submitted
- 25 May 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30656169
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Differences on Low Back Pain and Lower Extremity Isokinetic Muscle Strength and Balance
- ClinicalTrials.gov ID
- NCT05888051
- Acronym / sponsor ID
- E-10840098-772.02
- Conditions
- Back Pain
- Keywords
- balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 5 Jun 2023 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Adult | – | – |
| Adult | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants; Questions will be asked in total, including information such as age, gender, height, weight, dominant hand.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
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.
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.
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 17 Nov 2025.
- Background: PubMed 30656169Kim 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.
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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?
An observational study of Back Pain, run by Istanbul Medipol University Hospital 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 6 inclusion and 0 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 17 Nov 2025. 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 (time frame: one day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05888051, which also lists 1 linked publication.
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 17 Nov 2025; AzTrials last refreshed its copy on 2 Nov 2026.