Anti-TNF Therapy and Nerve Conduction Studies in Ankylosing Spondylitis

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04943237
Collaborator
(none)
60
1
3
19.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Anti-TNF Therapy and Nerve Conduction Studies in Patients With Ankylosing Spondylitis
Actual Study Start Date :
Jul 1, 2019
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Outcome Measures

Primary Outcome Measures

  1. nerve conduction studies [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Physical Medicine and Rehabilitation Training and research Hospital Istanbul Turkey

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04943237
Other Study ID Numbers:
  • IstPMRTRHatncsias
First Posted:
Jun 29, 2021
Last Update Posted:
Jun 29, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2021