Neuropathic Spinal Pain Descriptors in Ankylosing Spondylitis

NCT05096767 | Recruiting

• 1 other identifier: 355148EA
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have aimed to explore and interpret the neuropathic pain (NP) descriptors of spinal pain in patients with ankylosing spondylitis (AS). For this purpose they have attempted to initiate a prospective, cross-sectional study with AS patients.

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 selfreport. 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

• Neuropathic pain descriptors

  In the painDETECT questionnaire, seven items querying sensory abnormalities are scored between 0-5. Each of these abnormal sensations represent a pain descriptor. These descriptors are; burning, tingling, allodynia, pain attacks, thermal hyperalgesia, numbness and pressure hyperalgesia. A descriptor will accepted as positive if it is scored between 3 to 5

  Once, at baseline

Secondary Outcomes (1)

• Functional status

  Once, at baseline

Interventions

questionnaires and inventories OTHER

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

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 suffering from spinal pain with severity of 3 or more on 10 cm VAS

You may qualify if:

• Being diagnosed with AS according to the Modified NewYork Criteria
• Visual Analogue Scale spinal pain score ≥ 3

You may not qualify if:

• Diabetes mellitus, renal insufficiency, hypothyroidism
• Postherpetic neuralgia, spinal cord compression
• Being diagnosed as fibromyalgia in the last month or widespread pain indicating fibromyalgia
• Malignancy
• Pregnancy
• Severe cardiac disease
• 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 or anxiety

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Reseach Hospital

Izmir, 35300, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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

• Bidad K, Gracey E, Hemington KS, Mapplebeck JCS, Davis KD, Inman RD. Pain in ankylosing spondylitis: a neuro-immune collaboration. Nat Rev Rheumatol. 2017 Jul;13(7):410-420. doi: 10.1038/nrrheum.2017.92. Epub 2017 Jun 15.

  PMID: 28615730 BACKGROUND

• Heraughty M, Ridehalgh C. Sensory descriptors which identify neuropathic pain mechanisms in low back pain: a systematic review. Curr Med Res Opin. 2020 Oct;36(10):1695-1706. doi: 10.1080/03007995.2020.1790349. Epub 2020 Aug 4.

  PMID: 32609541 BACKGROUND

• Ji Y, He Y, Nian X, Sun E, Li L. Inflammatory or Neuropathic Pain: Characteristics and Their Relationships with Disease Activity and Functional Status in Axial Spondyloarthritis Patients. Pain Med. 2019 May 1;20(5):882-888. doi: 10.1093/pm/pny138.

  PMID: 30020521 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Surveys and Questionnaires; Equipment and Supplies

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

Study Officials

• Taciser Kaya, Prof., MD

  Izmir Bozyaka Training and Reseach Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taciser Kaya, Prof., MD

CONTACT

+905323948990; taciserkaya@gmail.com

Study Design

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

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 27, 2021
• Study Start: October 15, 2021
• Primary Completion: November 25, 2025
• Study Completion: December 25, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)