Anti-TNF Therapy and Nerve Conduction Studies in Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04943237
• Other study ID #: IstPMRTRHatncsias
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: June 2021
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Neuropathy
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Anti-TNF agents
Group of patients using anti-TNF for the last 5 years.
• 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

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine and Rehabilitation Training and research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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