Neuropathic Pain Symptoms in Arthritis | NCT05975281

Studies
Neuropathic Pain Symptoms in Arthritis

NCT05975281

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Status

Unknown status

Last Update Posted

Aug 7, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Neuropathic Pain

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2023Estimated

Primary Completion Date

Oct 1, 2023Estimated

Completion Date

Jan 1, 2024Estimated

First Submitted Date

Jul 27, 2023

First Submission Date that Met QC Criteria

Jul 27, 2023

First Posted Date

Aug 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2023

Last Update Posted Date

Aug 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Selda Çiftci, Medical Doctor, Department of Physical Medicine and Rehabilitation, Sisli Hamidiye Etfal Training and Research HospitalPrincipal Investigator

Lead Sponsor

Sisli Hamidiye Etfal Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

It was aimed to compare neuropathic pain symptoms in hand osteoarthritis and rheumatoid arthritis.

Detailed Description

The patients with hand osteoarthritis or neuropathic complaints accompanying rheumatoid arthritis who applied to the Physical Medicine and Rehabilitation Clinic of our hospital will be included. In both patient groups, the duration, character and treatments of their complaints will be compared. Neuropathic pain will be evaluated with the Visual Analog Score (VAS), Dolor Neuropathic 4 Questions (DN-4) and Pain Detect pain questionnaire.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hand osteoarthritis		Those diagnosed with hand osteoarthritis according to the American College of Rheumatology (ACR) criteria
Rheumatoid arthritis		Those diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analog Scale	0-10 ; higher score : severe pain	Day 1
DN-4	0-10 ; > 4 neuropathic pain	Day 1
Pain detect pain questionnaire	0-38 ; < 13 negative, 13-18 unclear, >18 positive	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presence of Hand Osteoarthritis and Rheumatoid Arthritis
Presence of neuropathic complaints

Exclusion Criteria:

History of hand injury, peripheral nerve injury, fracture, and hand operation in the last 3 months
Do not want to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

The patients with hand osteoarthritis or neuropathic complaints accompanying rheumatoid arthritis who applied to the Physical Medicine and Rehabilitation Clinic of Şişli Hamidiye Etfal Training and Research Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Selda Çiftci, MD	Contact	+905414857850		seldavd@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Şişli Hamidiye Etfal Training and Research Hospital		Istanbul			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D009437	Neuralgia
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided