Clinical trial NCT04943237: Anti-TNF Therapy and Nerve Conduction Studies in Ankylosing Spondylitis
Official title: Anti-TNF Therapy and Nerve Conduction Studies in Patients With Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anti - TNF Therapy
Ankylosing Spondylitis
Neuropathy
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: nerve conduction studies
timeFrame: All patients were evaluated in one session. The assesment of a patient lasted nearly 45-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training and research Hospital
Study officials:
affiliation: Istanbul physical Medicine and Rehabilitation Training and Research Hospital
name: Betül Yavuz Keleş, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul physical Medicine and Rehabilitation Training and Research Hospital
name: Ayşe Nur Bardak, prof
role: STUDY_DIRECTOR
References: