Low Back PainNCT05862116
Impact of Health Literacy on Chronic Non-specific Low Back Pain
An observational study of Low Back Pain, run by Uskudar State Hospital.
Trial summary
This prospective cohort study aims to assess the impact of health literacy on the quality of life in patients with chronic non-specific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Survey form
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Dec 2023
- How long will I take part?
- 1 Day
- 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: Patients with chronic non-specific low back pain that gave consent to participate in the study.
Who may be able to join
- -Chronic non-specific low back pain
Who cannot join
- Acute low back pain
- Radicular pain
- Spinal stenosis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Health Literacy on Quality of Life in Patients With Chronic Non-specific Low Back Pain: A Prospective Cohort Study
This prospective cohort study aims to assess the impact of health literacy on the quality of life in patients with chronic non-specific low back pain.
Read the detailed description
This prospective cohort study will enroll patients with chronic non-specific low back pain. Patients will be assessed using Turkey Health Literacy Scale-32, Short Form-36 Health Survey, and Oswestry Disability Index. The correlation between health literacy and quality of life will be assessed with statistical tests.
- Conditions
- Low Back Pain
- Being tested
- Survey form
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey formOther
Patients will be asked to fill a survey form that consists of socio-demographic information, Turkish Health Literacy Scale -32, Short Form-36 Health Survey and Oswestry Disability Index.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic non-specific low back pain | Patients with chronic non-specific low back pain. Receives: Other: Survey form |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between health literacy and quality of life
Using the statistical analysis, this trial will assess the correlation between health literacy and quality of life. The Turkey Health Literacy Scale-32 results and Short Form-36 Health Survey results will be tested for possible correlation. Also, oswestry disability index and Turkey Health Literacy Scale-32 will also be tested for a possible correlation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Uskudar State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Hüseyin Temel, Uskudar State Hospital
- Investigators
- Mustafa H Temel, M.D., Principal investigator, Uskudar State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862116
- Sponsor's protocol ID
- CNSLBP1
- Status last verified
- May 2023
- First submitted
- 7 May 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be shared upon reasonable request by the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Health Literacy on Quality of Life in Patients With Chronic Non-specific Low Back Pain: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05862116
- Acronym / sponsor ID
- CNSLBP1
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Uskudar State HospitalOther government
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 17 May 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.
This prospective cohort study aims to assess the impact of health literacy on the quality of life in patients with chronic non-specific low back pain.
Detailed description
This prospective cohort study will enroll patients with chronic non-specific low back pain. Patients will be assessed using Turkey Health Literacy Scale-32, Short Form-36 Health Survey, and Oswestry Disability Index. The correlation between health literacy and quality of life will be assessed with statistical tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic non-specific low back pain | – | Other: Survey formPatients with chronic non-specific low back pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic non-specific low back pain that gave consent to participate in the study.
Key inclusion criteria (1 listed)
- -Chronic non-specific low back pain
Key exclusion criteria (3 listed)
- Acute low back pain
- Radicular pain
- Spinal stenosis
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 |
|---|---|---|
| Survey formPatients will be asked to fill a survey form that consists of socio-demographic information, Turkish Health Literacy Scale -32, Short Form-36 Health Survey and Oswestry Disability Index. | Other | Patients with chronic non-specific low back pain |
Primary outcome
The correlation between health literacy and quality of life
Time frame: 1 day
Using the statistical analysis, this trial will assess the correlation between health literacy and quality of life. The Turkey Health Literacy Scale-32 results and Short Form-36 Health Survey results will be tested for possible correlation. Also, oswestry disability index and Turkey Health Literacy Scale-32 will also be tested for a possible correlation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: Undecided. Individual participant data will be shared upon reasonable request by the corresponding author.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Mustafa H Temel, M.D. principal investigator
Uskudar State Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Uskudar State Hospital.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa H Temel, M.D. (+905342714872, mhuseyintemel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between health literacy and quality of life (time frame: 1 day). 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 17 May 2023.