Chronic Low-back PainNCT05604027
Pain Types and Pain Severity in Chronic Low Back Pain
An observational study of Chronic Low-back Pain, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to characterize the distribution of pain phenotypes in people with chronic low back pain and to determine the effects of pain phenotypes on pain severity, functional status and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Visual Analogue Scale
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 1 Sep 2023
- 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 90 years
- All sexes
- Adult, Older adult
Study population: Patients who come to the hospital for chronic low back pain
Who may be able to join
- having chronic low back pain
- be over 18 years old
Who cannot join
- Those under the age of 18
- Those with major psychiatric illness,
- Those with communication problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Beyhekim Research and Training Hospital
Konya, Selçuklu, 42060
About this study
Official title: The Effects of Pain Types on Pain Severity and Quality of Life in Chronic Low Back Pain
The aim of this study is to characterize the distribution of pain phenotypes in people with chronic low back pain and to determine the effects of pain phenotypes on pain severity, functional status and quality of life.
Participants will be examined to determine the type of pain and questions will be asked to identify the effects.
- Conditions
- Chronic Low-back Pain
- Being tested
- Visual Analogue Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Analogue ScaleDiagnostic test
Also called Pain Catastrophizing Scale, The Roland-Morris Disability Questionnaire, Short form-36, painDETECT
Clinical criteria and rating system for nociplastic pain affecting the musculoskeletal system and PainDETECT scale to determine pain type SF-36 Quality of Life Scale, Roland Morris Disability Questionnaire, Pain Catastrophizing Scale, and Visual Analog Scale to determine the effects
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of pain types(determination of nociceptive, neuropathic, nociplastic pain rates)
Neuropathic pain with PainDETECT scale, Clinical criteria and rating system for nociplastic pain affecting the musculoskeletal system nosplastic pain will be evaluated
Measured: 01.03.2023
Pain levels of those with nociplastic, neuropathic and nociceptive pain
Pain severity with Visual Analogue Scale,(0-10)higher scores indicate more pain
Measured: 01.03.2023
pain effect
quality of life with SF-36,
Measured: 01.03.2023
disability,
disability with Roland Morris Disability Questionnaire,
Measured: 01.03.2023
patient's feelings, thoughts, and feelings about pain and disaster.
The Pain Catastrophizing Scale is used to assess the patient's feelings, thoughts, and feelings about pain and disaster.
Measured: 01.03.2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start15 Dec 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604027
- Sponsor's protocol ID
- 2022-15/20
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pain Types on Pain Severity and Quality of Life in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05604027
- Acronym / sponsor ID
- 2022-15/20
- Conditions
- Chronic Low-back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 3 Nov 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.
The aim of this study is to characterize the distribution of pain phenotypes in people with chronic low back pain and to determine the effects of pain phenotypes on pain severity, functional status and quality of life.
Participants will be examined to determine the type of pain and questions will be asked to identify the effects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who come to the hospital for chronic low back pain
Key inclusion criteria (2 listed)
- having chronic low back pain
- be over 18 years old
Key exclusion criteria (3 listed)
- Those under the age of 18
- Those with major psychiatric illness,
- Those with communication problems
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 |
|---|---|---|
| Visual Analogue ScaleAlso: Pain Catastrophizing Scale, The Roland-Morris Disability Questionnaire, Short form-36, painDETECTClinical criteria and rating system for nociplastic pain affecting the musculoskeletal system and PainDETECT scale to determine pain type SF-36 Quality of Life Scale, Roland Morris Disability Questionnaire, Pain Catastrophizing Scale, and Visual Analog Scale to determine the effects | Diagnostic test | – |
Primary outcome
identification of pain types(determination of nociceptive, neuropathic, nociplastic pain rates)
Time frame: 01.03.2023
Neuropathic pain with PainDETECT scale, Clinical criteria and rating system for nociplastic pain affecting the musculoskeletal system nosplastic pain will be evaluated
Pain levels of those with nociplastic, neuropathic and nociceptive pain
Time frame: 01.03.2023
Pain severity with Visual Analogue Scale,(0-10)higher scores indicate more pain
pain effect
Time frame: 01.03.2023
quality of life with SF-36,
disability,
Time frame: 01.03.2023
disability with Roland Morris Disability Questionnaire,
patient's feelings, thoughts, and feelings about pain and disaster.
Time frame: 01.03.2023
The Pain Catastrophizing Scale is used to assess the patient's feelings, thoughts, and feelings about pain and disaster.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Undecided. will be shared upon request.
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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 Chronic Low-back Pain, run by Konya Beyhekim Training and Research 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 2 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 3 Nov 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 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?
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?
identification of pain types(determination of nociceptive, neuropathic, nociplastic pain rates) (time frame: 01.03.2023). The study lists 5 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 3 Nov 2022.