Neuropathic Spinal Pain in Ankylosing Spondylitis

NCT04809168 | Active Not Recruiting

• 1 other identifier: 46418926TK
• Study Type: observational
• Target: 292
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Once, at baseline

Secondary Outcomes (2)

• Health related quality of life

  Once, at baseline

• Fatigue

  Once, at baseline

Study Arms (2)

AS patients

AS patients diagnosed according to the modified New York criteria

Other: Questionnaires and inventories

Control

Age- and sex-matched control subjects with nociceptive/mechanical pain complaint lasting more than three months

Other: Questionnaires and inventories

Interventions

Questionnaires and inventories OTHER

questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.

Also known as: physical examination

AS patients; Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Being diagnosed with AS according to the 1984 Modified New York Criteria
• Visual Analogue Scale (VAS) spinal pain score ≥ 2

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 25772656 BACKGROUND

• Geler-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.

  PMID: 29714437 BACKGROUND

• Choi 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.

  PMID: 29713968 BACKGROUND

• Wu 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.

  PMID: 23460087 BACKGROUND

• Li 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.

  PMID: 23058191 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Surveys and Questionnaires; Equipment and Supplies; Restraint, Physical

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• Taciser Kaya

  Izmir Bozyaka Training and Reseach Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 22, 2021
• Study Start: April 6, 2021
• Primary Completion: November 2, 2024
• Study Completion: December 2, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)