Anti-TNF Therapy and Nerve Conduction Studies in Ankylosing Spondylitis

NCT ID: NCT04943237

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2019-10-01

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.

Detailed Description

Demyelinating lesions in central nervous system after anti-TNF agents were reported previously. There are limited studies investigating the effects of anti-TNF treatments on the peripheral nervous system. The aim of this study is to investigate whether peripheral nerves are affected due to long-term use of anti-TNF agents.

Patients with a diagnosis of ankylosing spondylitis who received conventional or anti-TNF therapy for five years at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital were included in the study. The patients were divided into two groups as conventional group and anti-TNF group according to the treatment they received. All patients were evaluated in a single section. Sociodemographic characteristics of the patients and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functionality Index (BASFI) and Bath Ankylosing Spondylitis Metrology Index (BASMI) scores were recorded. Median-ulnar motor and sensory conduction studies and tibial-peroneal motor and sural nerve sensory conduction studies were performed in both upper extremities of all patients. Median, ulnar, and tibial nerve F-response studies were also performed.

Conditions

Anti - TNF Therapy; Ankylosing Spondylitis; Neuropathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Anti-TNF agents

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

Intervention Type: DRUG

Conventional therapy users for the last 5 years

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

Intervention Type: DRUG

Other Intervention Names

Anti-TNF agents users for the last 5 years.; Conventional therapy (non steroid anti inflammatory drugs and/or salazopyrin)

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betül Yavuz Keleş, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul physical Medicine and Rehabilitation Training and Research Hospital

Ayşe Nur Bardak, prof

Role: STUDY_DIRECTOR

Istanbul physical Medicine and Rehabilitation Training and Research Hospital

Locations

Istanbul Physical Medicine and Rehabilitation Training and research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IstPMRTRHatncsias

Identifier Type: -

Identifier Source: org_study_id