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Completed

NCT Number: NCT04943237

Anti-TNF Therapy and Nerve Conduction Studies in Ankylosing Spondylitis

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine and Rehabilitation Training and research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-TNF agents

Drug

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

Other names: 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

Other names: Conventional therapy (non steroid anti inflammatory drugs and/or salazopyrin)

Primary outcomes

  1. nerve conduction studies

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

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

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

Anti-TNF Therapy and Nerve Conduction Studies in Patients With Ankylosing Spondylitis

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2021
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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