NCT06990243

Brief Summary

Pain after spinal cord injury (SCI) is common, with the majority of individuals experiencing chronic pain and a significant portion reporting severe pain that interferes with their daily lives. Pain due to SCI is divided into two main groups: nociceptive and neuropathic. Clinical expertise is required for the accurate classification of these types of pain. Existing screening tools are generally evaluated with heterogeneous samples and therefore have limited accuracy in individuals with SCI. To address this deficiency, the Spinal Cord Injury Pain Instrument (SCIPI) was developed to define neuropathic pain in a manner specific to SCI. The SCIPI consists of seven items that assess the characteristics of pain and triggering factors. Although this scale, developed in English, has been translated into different languages, there is no Turkish version. This study aimed to examine the validity and reliability of the Turkish version of the SCIPI.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

May 28, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

April 19, 2025

Last Update Submit

May 17, 2025

Conditions

Keywords

Neuropathic painPsychometric propertiesSpinal cord injury pain instrument

Outcome Measures

Primary Outcomes (3)

  • The Spinal Cord Injury Pain Instrument (SCIPI)

    SCIPI was developed by Dr. Martin B. Forchheimer et al. to screen for neuropathic pain after spinal cord injury. It is an interview-based assessment tool designed to screen for neuropathic pain in individuals with SCI. SCIPI defines the pain characteristics of individuals and performs comparative analyses with clinical diagnoses. The validity and reliability properties of SCIPI were evaluated in a preliminary validation study. In this study, the following findings were obtained as a result of comparing the SCIPI with clinical diagnoses: sensitivity: 78%, specificity: 73%, and overall diagnostic accuracy: 76%. It shows that SCIPI is a reliable tool for screening neuropathic pain in individuals with spinal cord injury.

    1 week

  • DN4 Questionnaire

    DN4 is a questionnaire developed as a diagnostic tool that can be helpful both in daily practice and in clinical studies. It consists of 4 questions and a total of 10 items, including questions related to sensory complaints and bedside sensory examination findings, applied by the clinician. The first 2 questions are answered according to the patient's complaints, and the last 2 questions are answered according to the examination. The answers to the questions have 2 options as yes and no. Each positive item is given 1 point, and each negative item is given 0 points. The total score is calculated as the sum of 10 items, and the threshold value for neuropathic pain is determined as 4 points.

    1 week

  • Visual Analog Scale

    It is the most commonly used parameter to measure pain intensity. It is a self-reported scale consisting of a horizontal or vertical line, usually 10 cm long, with two verbal descriptors indicating the pain level fixed at the end points. The patient is asked to mark the point that best expresses their pain. The VAS value is obtained by considering the cm equivalent of the point they mark. '0' means no pain, '10' means unbearable pain.

    1 week

Interventions

An evaluation form will record the participants' socio-demographic characteristics and information about their disease/treatment. Consciousness and cognitive tests will be performed. Then, pain will be assessed with the Visual Analog Scale, 4-Question Neuropathic Pain Questionnaire,, and the Spinal Cord Injury Pain Instrument (SCIPI).

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals with spinal cord injuries

You may qualify if:

  • Having any level of SCI
  • Being 18-70 years old
  • Being at least one month since the SCI
  • Being inpatient rehabilitation or living in the community

You may not qualify if:

  • Having major depression
  • Having suicidal intent or plans
  • Being currently addicted to alcohol or drugs
  • Not taking stable doses of psychoactive medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeuralgiaSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 19, 2025

First Posted

May 25, 2025

Study Start

May 28, 2025

Primary Completion

June 28, 2025

Study Completion

July 28, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05