Chronic Nonspecific Low Back PainNCT07826546
Is Central Sensitization a Prognostic Indicator in Chronic Nonspecific Low Back Pain?
An observational study of Chronic Nonspecific Low Back Pain, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
This observational study will examine whether signs of increased sensitivity in the nervous system at the beginning of the study are associated with short-term clinical outcomes in adults with chronic nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Nonspecific Low Back Pain
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults aged 18-65 years with chronic nonspecific low back pain lasting for at least 3 months will be recruited from the Physical Medicine and Rehabilitation outpatient clinic of Mardin Training and Research Hospital. Participants will receive routine clinical care and will be evaluated at baseline and after 6 weeks. No healthy control group will be included.
Who may be able to join
- Adults aged 18 to 65 years
- Diagnosis of chronic nonspecific low back pain lasting for at least 3 months
- Willingness to participate in the study
- Ability to provide written informed consent
Who cannot join
- Progressive neurological deficit
- Inflammatory rheumatic disease
- Active malignancy
- History of serious spinal trauma or spinal surgery
- Cognitive impairment that may prevent completion of the assessments or follow-up
- Initiation, dose modification, or change of antidepressant or gabapentinoid treatment within the previous 3 months
- Pregnancy, postpartum period, or breastfeeding
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mardin Training and Research Hospital
Mardin, 47100
Taha Yasin YILDIRIM, M.D., +90 534 220 77 17, tyasinyildirim.ftr@gmail.com
Taha Yasin YILDIRIM, M.D.
About this study
Official title: The Prognostic Role of Central Sensitization in Short-Term Clinical Outcomes in Chronic Nonspecific Low Back Pain
This observational study will examine whether signs of increased sensitivity in the nervous system at the beginning of the study are associated with short-term clinical outcomes in adults with chronic nonspecific low back pain. Approximately 180 participants will complete questionnaires about central sensitization, disability, pain, anxiety, and depression at the beginning of the study.
After 6 weeks, disability, pain, and the participant's overall perception of change will be assessed again. The researchers will evaluate whether the initial level of central sensitization is associated with meaningful improvement in disability and perceived treatment benefit. Participants will not be assigned to a treatment as part of this study and will continue to receive routine clinical care.
Read the detailed description
Background: Chronic nonspecific low back pain may have different clinical outcomes among patients. These differences cannot always be explained by structural findings. Central sensitization may be one of the factors related to treatment outcomes.
Objective: This study aims to investigate whether the baseline Central Sensitization Inventory (CSI) score can predict short-term clinical improvement and perceived treatment benefit in patients with chronic nonspecific low back pain.
Method: This prospective observational study will include 180 adults with chronic nonspecific low back pain. At baseline, the CSI, Oswestry Disability Index (ODI), Visual Analog Scale for pain, and Hospital Anxiety and Depression Scale will be completed. After 6 weeks of routine clinical care, the ODI, pain score, and Global Rating of Change will be evaluated again. A decrease of at least 30% in the ODI score will be accepted as clinically meaningful improvement. The relationship between the baseline CSI score and clinical outcomes at 6 weeks will be analyzed.
- Conditions
- Chronic Nonspecific Low Back Pain
- Keywords
- Central Sensitization, Chronic Low Back Pain, Nonspecific Low Back Pain, Oswestry Disability Index, Prognostic Factor
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 |
|---|---|---|
| Chronic Nonspecific Low Back Pain Cohort | Adults aged 18-65 years with chronic nonspecific low back pain will be evaluated at baseline and followed for 6 weeks. Participants will receive routine clinical care determined by their treating physician. No treatment or intervention will be assigned by the study protocol. Baseline central sensitization symptoms will be evaluated in relation to disability, pain, and perceived improvement at 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically Meaningful Improvement in the Oswestry Disability Index
The proportion of participants who achieve a reduction of at least 30% in the Oswestry Disability Index (ODI) score from baseline. The ODI ranges from 0 to 100, with higher scores indicating greater disability.
Measured: Baseline to 6 weeks
Secondary outcomes (3)
Change in the Oswestry Disability Index Score
Change in the Oswestry Disability Index (ODI) score from baseline to 6 weeks. The ODI ranges from 0 to 100, with higher scores indicating greater disability. A greater reduction indicates greater improvement in disability.
Measured: Baseline to 6 weeks
Change in Pain Intensity
Change in pain intensity measured using a 0-10 Visual Analog Scale from baseline to 6 weeks. A score of 0 indicates no pain, and a score of 10 indicates the worst possible pain. A greater reduction indicates greater improvement in pain.
Measured: Baseline to 6 weeks
Patient-Perceived Improvement
Patient-perceived change in overall clinical status will be assessed using the Global Rating of Change scale at 6 weeks. Participants will report whether their condition has improved, remained unchanged, or worsened compared with baseline. The responses will be classified as perceived treatment benefit or no perceived treatment benefit according to the prespecified study criteria.
Measured: At 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Nonspecific 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Responsible party
- Principal investigator, Hatice Gözde Sümer, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826546
- Sponsor's protocol ID
- MarPRMTRH-TYY1
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
PubMed 20961685Nijs J, George SZ, Clauw DJ, Fernandez-de-Las-Penas C, Kosek E, Ickmans K, Fernandez-Carnero J, Polli A, Kapreli E, Huysmans E, Cuesta-Vargas AI, Mani R, Lundberg M, Leysen L, Rice D, Sterling M, Curatolo M. Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine. Lancet Rheumatol. 2021 May;3(5):e383-e392. doi: 10.1016/S2665-9913(21)00032-1. Epub 2021 Mar 30.
PubMed 38279393Sheenam N, Gaur R, Gonnade NM, Abins TK, Ghosh A, Hussain R. Central sensitisation in chronic low back pain: A cross-sectional study. Indian J Anaesth. 2025 Oct;69(10):1033-1038. doi: 10.4103/ija.ija_433_25. Epub 2025 Sep 5.
PubMed 40979767
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Role of Central Sensitization in Short-Term Clinical Outcomes in Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT07826546
- Acronym / sponsor ID
- MarPRMTRH-TYY1
- Conditions
- Chronic Nonspecific Low Back Pain
- Keywords
- Central Sensitization, Chronic Low Back Pain, Nonspecific Low Back Pain, Oswestry Disability Index, Prognostic Factor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 17 Sep 2026 (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 observational study will examine whether signs of increased sensitivity in the nervous system at the beginning of the study are associated with short-term clinical outcomes in adults with chronic nonspecific low back pain. Approximately 180 participants will complete questionnaires about central sensitization, disability, pain, anxiety, and depression at the beginning of the study.
After 6 weeks, disability, pain, and the participant's overall perception of change will be assessed again. The researchers will evaluate whether the initial level of central sensitization is associated with meaningful improvement in disability and perceived treatment benefit. Participants will not be assigned to a treatment as part of this study and will continue to receive routine clinical care.
Detailed description
Background: Chronic nonspecific low back pain may have different clinical outcomes among patients. These differences cannot always be explained by structural findings. Central sensitization may be one of the factors related to treatment outcomes.
Objective: This study aims to investigate whether the baseline Central Sensitization Inventory (CSI) score can predict short-term clinical improvement and perceived treatment benefit in patients with chronic nonspecific low back pain.
Method: This prospective observational study will include 180 adults with chronic nonspecific low back pain. At baseline, the CSI, Oswestry Disability Index (ODI), Visual Analog Scale for pain, and Hospital Anxiety and Depression Scale will be completed. After 6 weeks of routine clinical care, the ODI, pain score, and Global Rating of Change will be evaluated again. A decrease of at least 30% in the ODI score will be accepted as clinically meaningful improvement. The relationship between the baseline CSI score and clinical outcomes at 6 weeks will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Nonspecific Low Back Pain Cohort | – | –Adults aged 18-65 years with chronic nonspecific low back pain will be evaluated at baseline and followed for 6 weeks. Participants will receive routine clinical care determined by their treating physician. No treatment or intervention will be assigned by the study protocol. Baseline central sensitization symptoms will be evaluated in relation to disability, pain, and perceived improvement at 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-65 years with chronic nonspecific low back pain lasting for at least 3 months will be recruited from the Physical Medicine and Rehabilitation outpatient clinic of Mardin Training and Research Hospital. Participants will receive routine clinical care and will be evaluated at baseline and after 6 weeks. No healthy control group will be included.
Key inclusion criteria (4 listed)
- Adults aged 18 to 65 years
- Diagnosis of chronic nonspecific low back pain lasting for at least 3 months
- Willingness to participate in the study
- Ability to provide written informed consent
Key exclusion criteria (8 listed)
- Progressive neurological deficit
- Inflammatory rheumatic disease
- Active malignancy
- History of serious spinal trauma or spinal surgery
- Cognitive impairment that may prevent completion of the assessments or follow-up
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
Clinically Meaningful Improvement in the Oswestry Disability Index
Time frame: Baseline to 6 weeks
The proportion of participants who achieve a reduction of at least 30% in the Oswestry Disability Index (ODI) score from baseline. The ODI ranges from 0 to 100, with higher scores indicating greater disability.
3 secondary outcomes
Change in the Oswestry Disability Index Score
Time frame: Baseline to 6 weeks
Change in Pain Intensity
Time frame: Baseline to 6 weeks
Patient-Perceived Improvement
Time frame: At 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 20961685Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
- Background: PubMed 38279393Nijs J, George SZ, Clauw DJ, Fernandez-de-Las-Penas C, Kosek E, Ickmans K, Fernandez-Carnero J, Polli A, Kapreli E, Huysmans E, Cuesta-Vargas AI, Mani R, Lundberg M, Leysen L, Rice D, Sterling M, Curatolo M. Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine. Lancet Rheumatol. 2021 May;3(5):e383-e392. doi: 10.1016/S2665-9913(21)00032-1. Epub 2021 Mar 30.
- Background: PubMed 40979767Sheenam N, Gaur R, Gonnade NM, Abins TK, Ghosh A, Hussain R. Central sensitisation in chronic low back pain: A cross-sectional study. Indian J Anaesth. 2025 Oct;69(10):1033-1038. doi: 10.4103/ija.ija_433_25. Epub 2025 Sep 5.
- Individual participant dataSharing planned: No
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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.
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 Nonspecific Low Back Pain, run by Mardin Artuklu University 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taha Yasin YILDIRIM, M.D. (+90 534 220 77 17, tyasinyildirim.ftr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Meaningful Improvement in the Oswestry Disability Index (time frame: Baseline to 6 weeks). 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 NCT07826546, which also lists 3 linked publications.
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 Sep 2026.