Anti-TNF Therapy and Nerve Conduction Studies in Ankylosing Spondylitis

Anti-TNF Therapy and Nerve Conduction Studies in Patients With 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.

Study Overview

• Status: Completed
• Conditions: Neuropathy; Ankylosing Spondylitis; Anti - TNF Therapy
• Intervention / Treatment: Drug: Anti-TNF agents; Drug: Conventional therapy users for the last 5 years

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Physical Medicine and Rehabilitation Training and research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Investigators: Principal Investigator: Betül Yavuz Keleş, MD, Istanbul Physical Medicine and Rehabilitation Training and research Hospital; Study Director: Ayşe Nur Bardak, prof, Istanbul Physical Medicine and Rehabilitation Training and research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: June 19, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Antirheumatic Agents; Gastrointestinal Agents; Anti-Inflammatory Agents; Sulfasalazine
• Other Study ID Numbers: IstPMRTRHatncsias

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No