Anti-TNF Therapy and Nerve Conduction Studies in Ankylosing Spondylitis

NCT04943237 | Completed

• 1 other identifier: IstPMRTRHatncsias
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with ankylosing spondylitis were divided into 2 groups as anti-TNF and conventional therapy according to the treatments they were using for the last 5 years. Nerve conduction studies in the upper and lower extremities of the patients were compared.

Conditions

Anti - TNF Therapy; Ankylosing Spondylitis; Neuropathy

Outcome Measures

Primary Outcomes (1)

• nerve conduction studies

  The evaluation of median, ulnar, tibial, peroneal and sural nerves

  All patients were evaluated in one session. The assesment of a patient lasted nearly 45-60 minutes

Interventions

Anti-TNF agents DRUG

Group of patients using anti-TNF for the last 5 years.

Also known as: Anti-TNF agents users for the last 5 years.

Conventional therapy users for the last 5 years DRUG

Group of patients not using anti-TNF. Group of patients using conventional therapy (non -steroid anti-inflammatory drugs and/or salazopyrin) for the last 5 years

Also known as: Conventional therapy (non steroid anti inflammatory drugs and/or salazopyrin)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had the diagnosis of ankylosing spondylitis and had used conventional or anti-TNF therapy at least 5 years.

You may qualify if:

• Patients diagnosed with ankylosing spondylitis
• Patients who have been using conventional therapy (non-steroidal anti-inflammatory drugs and/or salazopyrin) or anti-TNF therapy for more than 5 years.

You may not qualify if:

• Patients with rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus ......)
• Patients with other systemic diseases that can lead to neuropathy
• Patients who have had a known neuropathy or have taken medication that can lead to neuropathy as a side effect
• Patients with pacemakers

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

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

Study Officials

• Betül Yavuz Keleş, MD

  Istanbul physical Medicine and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ayşe Nur Bardak, prof

  Istanbul physical Medicine and Rehabilitation Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: June 29, 2021
• Study Start: July 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

TU (1)