Neuropathic PainNCT05975281
Neuropathic Pain Symptoms in Arthritis
An observational study of Neuropathic Pain, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to compare neuropathic pain symptoms in hand osteoarthritis and rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neuropathic Pain
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jul 2023to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Presence of Hand Osteoarthritis and Rheumatoid Arthritis
- Presence of neuropathic complaints
Who cannot join
- History of hand injury, peripheral nerve injury, fracture, and hand operation in the last 3 months
- Do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
Official title: Comparison of Neuropathic Pain Symptoms in Hand Osteoarthritis and Rheumatoid Arthritis
It was aimed to compare neuropathic pain symptoms in hand osteoarthritis and rheumatoid arthritis.
Read the 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.
- Conditions
- Neuropathic Pain
- Keywords
- hand osteoarthritis, neuropathic pain, neuropathic symptom, rheumatoid arthritis
- Medical subject headings
- Neuralgia, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
0-10 ; higher score : severe pain
Measured: Day 1
DN-4
0-10 ; > 4 neuropathic pain
Measured: Day 1
Pain detect pain questionnaire
0-38 ; < 13 negative, 13-18 unclear, >18 positive
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start27 Jul 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Çiftci, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975281
- Sponsor's protocol ID
- 28052023
- Status last verified
- Aug 2023
- First submitted
- 27 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Neuropathic Pain Symptoms in Hand Osteoarthritis and Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05975281
- Acronym / sponsor ID
- 28052023
- Conditions
- Neuropathic Pain
- Keywords
- hand osteoarthritis, neuropathic pain, neuropathic symptom, rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 27 Jul 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- Presence of Hand Osteoarthritis and Rheumatoid Arthritis
- Presence of neuropathic complaints
Key exclusion criteria (2 listed)
- History of hand injury, peripheral nerve injury, fracture, and hand operation in the last 3 months
- Do not want to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analog Scale
Time frame: Day 1
0-10 ; higher score : severe pain
DN-4
Time frame: Day 1
0-10 ; > 4 neuropathic pain
Pain detect pain questionnaire
Time frame: Day 1
0-38 ; < 13 negative, 13-18 unclear, >18 positive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selda Çiftci, MD (+905414857850, seldavd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.