Neuropathic PainNCT03544619
Reliability and Cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory
An observational study of Neuropathic Pain, run by Erenköy Physical Therapy and Rehabilitation Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigators want to perform the reliability and cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Neuropathic Pain Symptom Inventory
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2018to 30 Dec 2020
- How long will I take part?
- 3 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have neuropathic symptoms
Who may be able to join
- Age upper 18
- Complaints of neuropathic pain for at least 3 months
Who cannot join
- Presence of psychiatric illness
- Cancer pain, unsuccessful lumbar surgeon syndrome etc. mix type pain presence
- Presence of complex regional pain syndrome
- Cognitive impairment (mini-mental test score <24)
- Native language is not Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erenkoy Physical Treatment Nad Rehabilitation Hospital
Istanbul, 34400
About this study
In this study, investigators want to perform the reliability and cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory
Read the detailed description
The purpose of the study is to determine the Turkish version, the reliability and cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory. 120 patients with neuropathic pain will be included in the study. Test-retest and internal consistency analysis were conducted to determine the reliability of the questionnaire. Test-retest results evaluated using the Intraclass Correlation Coefficient method.
- Conditions
- Neuropathic Pain
- Being tested
- Neuropathic Pain Symptom Inventory
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropathic Pain Symptom InventoryOther
Investigators will use the Neuropathic Pain Symptom Inventory for assessing neuropathic symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability and adaptation
Investigators will use linguistic validaiton guideline of Mapi research.
Measured: 7 weeks
DN4
DN4 has become one of the principal condition-specific outcome measures of neuropathic pain.Investigators will use it for comparing results of NPSI.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start10 Jun 2018
- Primary completion25 Dec 2020 (estimated)
- Study completion30 Dec 2020 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Erenköy Physical Therapy and Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYLİN SARI, Erenköy Physical Therapy and Rehabilitation Hospital
- Investigators
- unsal sarı, Study chair, ERENKOY PHYSICAL THERAPY AND REHABILITATION HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544619
- Sponsor's protocol ID
- AYLIN2
- Status last verified
- May 2020
- First submitted
- 21 May 2018
- Last updated
- 13 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory
- ClinicalTrials.gov ID
- NCT03544619
- Acronym / sponsor ID
- AYLIN2
- Conditions
- Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Erenköy Physical Therapy and Rehabilitation HospitalUniversity, hospital or other
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- 25 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 4 Jun 2018 (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.
In this study, investigators want to perform the reliability and cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory
Detailed description
The purpose of the study is to determine the Turkish version, the reliability and cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory. 120 patients with neuropathic pain will be included in the study. Test-retest and internal consistency analysis were conducted to determine the reliability of the questionnaire. Test-retest results evaluated using the Intraclass Correlation Coefficient method.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have neuropathic symptoms
Key inclusion criteria (2 listed)
- Age upper 18
- Complaints of neuropathic pain for at least 3 months
Key exclusion criteria (5 listed)
- Presence of psychiatric illness
- Cancer pain, unsuccessful lumbar surgeon syndrome etc. mix type pain presence
- Presence of complex regional pain syndrome
- Cognitive impairment (mini-mental test score <24)
- Native language is not Turkish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropathic Pain Symptom InventoryInvestigators will use the Neuropathic Pain Symptom Inventory for assessing neuropathic symptoms | Other | – |
Primary outcome
Reliability and adaptation
Time frame: 7 weeks
Investigators will use linguistic validaiton guideline of Mapi research.
DN4
Time frame: 5 minutes
DN4 has become one of the principal condition-specific outcome measures of neuropathic pain.Investigators will use it for comparing results of NPSI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
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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.
unsal sarı study chair
ERENKOY PHYSICAL THERAPY AND REHABILITATION HOSPITAL
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 Erenköy Physical Therapy and Rehabilitation 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 5 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 13 May 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability and adaptation (time frame: 7 weeks). The study lists 2 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 13 May 2020.