Low Back PainLBP PILLOWNCT05486845
Special Lower Back Pillow Examination
A study testing survey in people with Low Back Pain, run by Szeged University at 1 site in Hungary.
Trial summary
Low back pain is a significant, serious and widespread problem in our world today, both in terms of social and economic burdens. It should be emphasized that even the young adult age group is very often affected by non-specific, low back pain without proven pathoanatomical changes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jul 2022to 1 Jul 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in case of patients with low back pain: chronic pain
- in case of asymptomatic individuals: no symptomes
Who cannot join
- serious neurologycal symptomes
- serious scoliosis
- previous surgery which affected the local stabilizers
- serious pulmonar disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Use of Lower Back Pillow.
Low back pain is a significant, serious and widespread problem in our world today, both in terms of social and economic burdens. It should be emphasized that even the young adult age group is very often affected by non-specific, low back pain without proven pathoanatomical changes.
Read the detailed description
We plan to examine the use of a special lower back pillow and the time period of the sitting position. We would like to know how it helps to prevent and treat low back pain. We would like to know more about the people's pillow usage habits.
We are planning a questionnaire survey. We combine our own questions with validated, official questionnaires. Validated forms ask for an assessment of the extent of low back pain and the quality of experienced stress.
- Conditions
- Low Back Pain
- Being tested
- survey
- Keywords
- LBP, special pillow, lower back pillow
- 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.
surveyOther
We are planning a questionnaire survey. We combine our own questions with validated, official questionnaires. Validated forms ask for an assessment of the extent of low back pain and the quality of experienced stress.
| Study group | Role | What they receive |
|---|---|---|
| adults | Experimental | People who use the lower back pillow. Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEDICAL HISTORY RECORD SHEET
We created an individual patient examination form, in which we could ask our subjects about their lifestyle habits and about their low back pain.
Measured: 3 minutes
THE QUEBEC BACK PAIN DISABILITY SCALE (QBPDS)
The Quebec back pain disability scale is a condition-specific questionnaire developed to measure the level of functional disability for patients with low back pain (LBP) is a condition-specific questionnaire developed to measure the level of functional disability for patients with low back pain (LBP). The original purpose of the questionnaire is to take into account the functional limitations related to pain, to monitor the progress of individual patients and to compare the evolution of LBP subjects incorporated in rehabilitation programs.
Measured: 2 minutes
THE PERCEIVED STRESS SCALE (PSS)
The Perceived Stress Scale is a classic stress assessment instrument. The tool remains a popular choice for helping us understand how different situations affect our feelings and our perceived stress. The questions in this scale ask about your feelings and thoughts during the last month. In each case, you will be asked to indicate how often you felt or thought a certainn way.
Measured: 2 minutes
VISUAL ANALOG SCALE
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. VAS is the most common pain scale.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Jul 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486845
- Sponsor's protocol ID
- SzegedU_LBP PILLOW
- Acronym
- LBP PILLOW
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Use of Lower Back Pillow.
- ClinicalTrials.gov ID
- NCT05486845
- Acronym / sponsor ID
- LBP PILLOW / SzegedU_LBP PILLOW
- Conditions
- Low Back Pain
- Keywords
- LBP, special pillow, lower back pillow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 4 Aug 2022 (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 a significant, serious and widespread problem in our world today, both in terms of social and economic burdens. It should be emphasized that even the young adult age group is very often affected by non-specific, low back pain without proven pathoanatomical changes.
Detailed description
We plan to examine the use of a special lower back pillow and the time period of the sitting position. We would like to know how it helps to prevent and treat low back pain. We would like to know more about the people's pillow usage habits.
We are planning a questionnaire survey. We combine our own questions with validated, official questionnaires. Validated forms ask for an assessment of the extent of low back pain and the quality of experienced stress.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults | Experimental | Other: surveyPeople who use the lower back pillow. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- in case of patients with low back pain: chronic pain
- in case of asymptomatic individuals: no symptomes
Key exclusion criteria (4 listed)
- serious neurologycal symptomes
- serious scoliosis
- previous surgery which affected the local stabilizers
- serious pulmonar disease
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 |
|---|---|---|
| surveyWe are planning a questionnaire survey. We combine our own questions with validated, official questionnaires. Validated forms ask for an assessment of the extent of low back pain and the quality of experienced stress. | Other | adults |
Primary outcome
MEDICAL HISTORY RECORD SHEET
Time frame: 3 minutes
We created an individual patient examination form, in which we could ask our subjects about their lifestyle habits and about their low back pain.
THE QUEBEC BACK PAIN DISABILITY SCALE (QBPDS)
Time frame: 2 minutes
The Quebec back pain disability scale is a condition-specific questionnaire developed to measure the level of functional disability for patients with low back pain (LBP) is a condition-specific questionnaire developed to measure the level of functional disability for patients with low back pain (LBP). The original purpose of the questionnaire is to take into account the functional limitations related to pain, to monitor the progress of individual patients and to compare the evolution of LBP subjects incorporated in rehabilitation programs.
THE PERCEIVED STRESS SCALE (PSS)
Time frame: 2 minutes
The Perceived Stress Scale is a classic stress assessment instrument. The tool remains a popular choice for helping us understand how different situations affect our feelings and our perceived stress. The questions in this scale ask about your feelings and thoughts during the last month. In each case, you will be asked to indicate how often you felt or thought a certainn way.
VISUAL ANALOG SCALE
Time frame: 1 minute
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. VAS is the most common pain scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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?
A study testing survey in people with Low Back Pain, run by Szeged University at 1 site in Hungary.
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 2 inclusion and 4 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 4 Aug 2022. 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 Hungary. 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?
Results are not available in the source record.
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?
MEDICAL HISTORY RECORD SHEET (time frame: 3 minutes). 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?
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 4 Aug 2022.