NCT05975281

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

July 27, 2023

Last Update Submit

August 3, 2023

Conditions

Keywords

hand osteoarthritisneuropathic painneuropathic symptomrheumatoid arthritis

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Presence of Hand Osteoarthritis and Rheumatoid Arthritis
  • Presence of neuropathic complaints

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeuralgiaArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Selda Çiftci, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Department of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 3, 2023

Study Start

July 27, 2023

Primary Completion

October 1, 2023

Study Completion

January 1, 2024

Last Updated

August 7, 2023

Record last verified: 2023-08

Locations