Ankylosing SpondylitisNCT04809168
Neuropathic Spinal Pain in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate prevalence of neuropathic spinal pain in AS patients and it's impact on sleep quality. Moreover effects of neuropathic pain on quality of life and fatigue will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Questionnaires and inventories
- How many people
- 292 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2021to 2 May 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AS patients and age- and sex-matched control subjects will be chosen among individuals submitting to our out-patient clinic with nociceptive/mechanical pain complaint lasting more than three months.
Who may be able to join
- Being diagnosed with AS according to the 1984 Modified New York Criteria
- Visual Analogue Scale (VAS) spinal pain score ≥ 2
Who cannot join
- Diabetes mellitus, renal insufficiency, hypothyroidism
- Carpal tunnel syndrome, postherpetic neuralgia, spinal cord compression
- Neurological diseases leading to neuropathic pain
- Cervical and lumbar radiculopathy
- Fibromyalgia
- Malignancy
Show all 11Show fewer
- Severe cardiac disease
- Pregnancy
- Muscle weakness or hypoesthesia indicating peripheral nerve injury
- In the last three months medical treatment leading to neuropathy (colchicine etc.)
- In the last three months drug use for the treatment of fibromyalgia, depression and anxiety
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Training and Research Hospital
Izmir
About this study
Official title: Prevalence of Spinal Neuropathic Pain in Ankylosing Spondylitis Patients and it's Impact on Sleep Quality: a Case-control Study
The aim of this study is to investigate prevalence of neuropathic spinal pain in AS patients and it's impact on sleep quality. Moreover effects of neuropathic pain on quality of life and fatigue will be assessed.
Read the detailed description
Ankylosing spondylitis (AS) is a chronic, inflammatory rheumatic disease that mainly presenting with chronic back pain. In general, chronic low back pain is currently defined as a mixed pain including nociceptive and neuropathic properties. Nociceptive pain in several rheumatic diseases displays neuropathic characteristics over time. Patients with AS are suffered from spinal, entheseal pain or pain originated from peripheral and root joints. Although being scarce, there are trials investigating and reporting neuropathic component of spinal pain in axial spondyloarthritis/ankylosing spondylitis patients. However these trials either are not controlled or did not specify painful region of interest. In a few controlled trials control subjects were not defined clearly.
Sleep problems are reported to be prevalent among patients with chronic pain conditions such as inflammatory rheumatic diseases and fibromyalgia. In patients with ankylosing spondylitis sleep disturbance is a well defined issue. The fact that sleep problem is a common problem in AS, raises the need to explore it's associates. In the trials measuring spinal neuropathic pain, sleep disturbances and it's association with neuropathic pain were not assessed.
So, investigators have aimed to investigate prevalence of neuropathic spinal pain in AS patients and it's impact on sleep quality. For this purpose a case-control study design was planned. Age- and sex-matched control subjects will be chosen among individuals submitted to out-patient clinic with nociceptive/mechanical pain complaint lasting more than three months. Participants in control group will be subjected to same exclusion criteria too.
This design will allow the investigators to determine whether spinal pain in AS patients displays neuropathic character more frequently than any chronic nociceptive pain does.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Questionnaires and inventories
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and inventoriesOther
Also called physical examination
questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.
| Study group | Role | What they receive |
|---|---|---|
| AS patients | AS patients diagnosed according to the modified New York criteria Receives: Other: Questionnaires and inventories | |
| Control | Age- and sex-matched control subjects with nociceptive/mechanical pain complaint lasting more than three months Receives: Other: Questionnaires and inventories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic pain
It will be assessed using the PainDETECT questionnaire. This questionnaire contains nine questions all of which are self-report. Seven items are rated on a six point Likert scale and thus are scored between 0-5. These seven questions query some sensations such as burning, tingling or prickling, allodynia, numbness etc. Apart from these seven items, one item assesses the radiation of pain and the other one item looks for the temporal characteristics of pain. A total score of 12 or less indicates neuropathic component is unlikely, 13-18 means possible neuropathic component and 19 or greater means a neuropathic component is likely. Beside these, there are three items in a separate section measuring severity of pain at the time of evaluation, on average and maximum over the past month. This section is not taken into account in scoring
Measured: Once, at baseline
Sleep quality
It will be assessed using Pittsburgh Sleep Quality Index (PSQI). It was developed by Buysse and coworkers in 1989. This index measures sleep quality quantitatively and covers 24 questions. Nineteen questions are self-rated and scoring is based on these self-rated questions, other five questions that rating by partner are not taken into account while calculating total score. Questionnaire measures seven domains; subjective sleep quality (question 6), sleep latency (question 2 and 5a), sleep duration (question 4), habitual sleep efficiency (question 1,3,4), sleep disturbances (question 5b-j), use of sleep medication (question 7), and daytime dysfunction (question 8 and 9) over the last month. Seven domain scores give a result on a 0 to 3 scale. To yield a total score the domain scores are summed. Total score varies between 0 and 21. Higher scores indicate worse sleep quality.
Measured: Once, at baseline
Secondary outcomes (2)
Health related quality of life
Health related quality of life will be assessed using (Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) querying symptoms, functioning, and disease-related concern. It covers 18 dichotomous questions that ask participants to answer in a yes or no fashion. An answer of "yes" is assumed as one point. To get a final score, all points are summed. Thus, total score is between 0-18 and higher scores indicate worse quality of life.
Measured: Once, at baseline
Fatigue
It will be assessed using Fatigue Severity Scale. This scale contains nine questions and measures fatigue severity during the past week. Each question is rated between 1 (strongly disagree)-7 (strongly disagree). Total score is mean of all To calculate total score first the points of all answers are summed and then the result is divided by nine. Higher scores indicate severe fatigue
Measured: Once, at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start6 Apr 2021
- Primary completion2 Nov 2024
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies 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
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taciser Kaya, Bozyaka Training and Research Hospital
- Investigators
- Taciser Kaya, Study director, Izmir Bozyaka Training and Reseach Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809168
- Sponsor's protocol ID
- 46418926TK
- Status last verified
- Nov 2026
- First submitted
- 19 Mar 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aydin E, Bayraktar K, Turan Y, Omurlu I, Tastaban E, Sendur OF. [Sleep quality in patients with ankylosing spondylitis]. Rev Bras Reumatol. 2015 Jul-Aug;55(4):340-5. doi: 10.1016/j.rbr.2014.12.007. Epub 2015 Feb 9. Portuguese.
PubMed 25772656Geler-Kulcu D, Batibay S, Ozturk G, Mesci N. The association of neuropathic pain and disease activity, functional level, and quality of life in patients with ankylosing spondylitis: a cross-sectional study. Turk J Med Sci. 2018 Apr 30;48(2):257-265. doi: 10.3906/sag-1707-147.
PubMed 29714437Choi JH, Lee SH, Kim HR, Lee KA. Association of neuropathic-like pain characteristics with clinical and radiographic features in patients with ankylosing spondylitis. Clin Rheumatol. 2018 Nov;37(11):3077-3086. doi: 10.1007/s10067-018-4125-z. Epub 2018 Apr 30.
PubMed 29713968Wu Q, Inman RD, Davis KD. Neuropathic pain in ankylosing spondylitis: a psychophysics and brain imaging study. Arthritis Rheum. 2013 Jun;65(6):1494-503. doi: 10.1002/art.37920.
PubMed 23460087Li Y, Zhang S, Zhu J, Du X, Huang F. Sleep disturbances are associated with increased pain, disease activity, depression, and anxiety in ankylosing spondylitis: a case-control study. Arthritis Res Ther. 2012 Oct 11;14(5):R215. doi: 10.1186/ar4054.
PubMed 23058191
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Spinal Neuropathic Pain in Ankylosing Spondylitis Patients and it's Impact on Sleep Quality: a Case-control Study
- ClinicalTrials.gov ID
- NCT04809168
- Acronym / sponsor ID
- 46418926TK
- Conditions
- Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 2 Nov 2024 (actual)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 22 Mar 2021 (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 investigate prevalence of neuropathic spinal pain in AS patients and it's impact on sleep quality. Moreover effects of neuropathic pain on quality of life and fatigue will be assessed.
Detailed description
Ankylosing spondylitis (AS) is a chronic, inflammatory rheumatic disease that mainly presenting with chronic back pain. In general, chronic low back pain is currently defined as a mixed pain including nociceptive and neuropathic properties. Nociceptive pain in several rheumatic diseases displays neuropathic characteristics over time. Patients with AS are suffered from spinal, entheseal pain or pain originated from peripheral and root joints. Although being scarce, there are trials investigating and reporting neuropathic component of spinal pain in axial spondyloarthritis/ankylosing spondylitis patients. However these trials either are not controlled or did not specify painful region of interest. In a few controlled trials control subjects were not defined clearly.
Sleep problems are reported to be prevalent among patients with chronic pain conditions such as inflammatory rheumatic diseases and fibromyalgia. In patients with ankylosing spondylitis sleep disturbance is a well defined issue. The fact that sleep problem is a common problem in AS, raises the need to explore it's associates. In the trials measuring spinal neuropathic pain, sleep disturbances and it's association with neuropathic pain were not assessed.
So, investigators have aimed to investigate prevalence of neuropathic spinal pain in AS patients and it's impact on sleep quality. For this purpose a case-control study design was planned. Age- and sex-matched control subjects will be chosen among individuals submitted to out-patient clinic with nociceptive/mechanical pain complaint lasting more than three months. Participants in control group will be subjected to same exclusion criteria too.
This design will allow the investigators to determine whether spinal pain in AS patients displays neuropathic character more frequently than any chronic nociceptive pain does.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AS patients | – | Other: Questionnaires and inventoriesAS patients diagnosed according to the modified New York criteria |
| Control | – | Other: Questionnaires and inventoriesAge- and sex-matched control subjects with nociceptive/mechanical pain complaint lasting more than three months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AS patients and age- and sex-matched control subjects will be chosen among individuals submitting to our out-patient clinic with nociceptive/mechanical pain complaint lasting more than three months.
Key inclusion criteria (2 listed)
- Being diagnosed with AS according to the 1984 Modified New York Criteria
- Visual Analogue Scale (VAS) spinal pain score ≥ 2
Key exclusion criteria (11 listed)
- Diabetes mellitus, renal insufficiency, hypothyroidism
- Carpal tunnel syndrome, postherpetic neuralgia, spinal cord compression
- Neurological diseases leading to neuropathic pain
- Cervical and lumbar radiculopathy
- Fibromyalgia
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 |
|---|---|---|
| Questionnaires and inventoriesAlso: physical examinationquestionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed. | Other | AS patients, Control |
Primary outcome
Neuropathic pain
Time frame: Once, at baseline
It will be assessed using the PainDETECT questionnaire. This questionnaire contains nine questions all of which are self-report. Seven items are rated on a six point Likert scale and thus are scored between 0-5. These seven questions query some sensations such as burning, tingling or prickling, allodynia, numbness etc. Apart from these seven items, one item assesses the radiation of pain and the other one item looks for the temporal characteristics of pain. A total score of 12 or less indicates neuropathic component is unlikely, 13-18 means possible neuropathic component and 19 or greater means a neuropathic component is likely. Beside these, there are three items in a separate section measuring severity of pain at the time of evaluation, on average and maximum over the past month. This section is not taken into account in scoring
Sleep quality
Time frame: Once, at baseline
It will be assessed using Pittsburgh Sleep Quality Index (PSQI). It was developed by Buysse and coworkers in 1989. This index measures sleep quality quantitatively and covers 24 questions. Nineteen questions are self-rated and scoring is based on these self-rated questions, other five questions that rating by partner are not taken into account while calculating total score. Questionnaire measures seven domains; subjective sleep quality (question 6), sleep latency (question 2 and 5a), sleep duration (question 4), habitual sleep efficiency (question 1,3,4), sleep disturbances (question 5b-j), use of sleep medication (question 7), and daytime dysfunction (question 8 and 9) over the last month. Seven domain scores give a result on a 0 to 3 scale. To yield a total score the domain scores are summed. Total score varies between 0 and 21. Higher scores indicate worse sleep quality.
2 secondary outcomes
Health related quality of life
Time frame: Once, at baseline
Fatigue
Time frame: Once, at baseline
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 4 Nov 2026.
- Background: PubMed 25772656Aydin E, Bayraktar K, Turan Y, Omurlu I, Tastaban E, Sendur OF. [Sleep quality in patients with ankylosing spondylitis]. Rev Bras Reumatol. 2015 Jul-Aug;55(4):340-5. doi: 10.1016/j.rbr.2014.12.007. Epub 2015 Feb 9. Portuguese.
- Background: PubMed 29714437Geler-Kulcu D, Batibay S, Ozturk G, Mesci N. The association of neuropathic pain and disease activity, functional level, and quality of life in patients with ankylosing spondylitis: a cross-sectional study. Turk J Med Sci. 2018 Apr 30;48(2):257-265. doi: 10.3906/sag-1707-147.
- Background: PubMed 29713968Choi JH, Lee SH, Kim HR, Lee KA. Association of neuropathic-like pain characteristics with clinical and radiographic features in patients with ankylosing spondylitis. Clin Rheumatol. 2018 Nov;37(11):3077-3086. doi: 10.1007/s10067-018-4125-z. Epub 2018 Apr 30.
- Background: PubMed 23460087Wu Q, Inman RD, Davis KD. Neuropathic pain in ankylosing spondylitis: a psychophysics and brain imaging study. Arthritis Rheum. 2013 Jun;65(6):1494-503. doi: 10.1002/art.37920.
- Background: PubMed 23058191Li Y, Zhang S, Zhu J, Du X, Huang F. Sleep disturbances are associated with increased pain, disease activity, depression, and anxiety in ankylosing spondylitis: a case-control study. Arthritis Res Ther. 2012 Oct 11;14(5):R215. doi: 10.1186/ar4054.
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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.
Taciser Kaya study director
Izmir Bozyaka Training and Reseach Hospital
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 Ankylosing Spondylitis, run by Bozyaka 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 11 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 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?
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?
Neuropathic pain (time frame: Once, at baseline). The study lists 2 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 NCT04809168, which also lists 5 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 4 Nov 2026.