Reliability and Cross-cultural Adaptation of the Turkish... | NCT03544619

Studies
Reliability and Cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory

NCT03544619

Sponsor

Erenköy Physical Therapy and Rehabilitation Hospital

Status

Unknown status

Last Update Posted

May 13, 2020Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Neuropathic Pain

Interventions

Neuropathic Pain Symptom Inventory

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

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2018Actual

Primary Completion Date

Dec 25, 2020Estimated

Completion Date

Dec 30, 2020Estimated

First Submitted Date

May 21, 2018

First Submission Date that Met QC Criteria

May 31, 2018

First Posted Date

Jun 4, 2018Actual

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

May 11, 2020

Last Update Posted Date

May 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

AYLİN SARI, Medical doctor, specialist on physical therapy and rehabilitation, Erenköy Physical Therapy and Rehabilitation HospitalPrincipal Investigator

Lead Sponsor

Erenköy Physical Therapy and Rehabilitation HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuropathic Pain Symptom Inventory	Other	Investigators will use the Neuropathic Pain Symptom Inventory for assessing neuropathic symptoms

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reliability and adaptation	Investigators will use linguistic validaiton guideline of Mapi research.	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.	5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age upper 18
Complaints of neuropathic pain for at least 3 months

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who have neuropathic symptoms

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
unsal sarı	ERENKOY PHYSICAL THERAPY AND REHABILITATION HOSPITAL	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erenkoy Physical Treatment Nad Rehabilitation Hospital		Istanbul		34400	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009437	Neuralgia

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