Neuropathic PainNCT06990243
Reliability and Validity of the Turkish Version of the SCIPI
An observational study of Neuropathic Pain and Spinal Cord Injury, run by Istinye University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuropathic Pain, Spinal Cord Injury
- What is being tested?
- Evaluation Group
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2025to 28 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with spinal cord injuries
Who may be able to join
- 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
Who cannot join
- Having major depression
- Having suicidal intent or plans
- Being currently addicted to alcohol or drugs
- Not taking stable doses of psychoactive medications
About this study
Official title: Reliability and Validity of the Turkish Version of the Spinal Cord Injury Pain Instrument
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.
Read the detailed description
Pain after spinal cord injury (SCI) is a common problem. Approximately 80% of individuals with SCI experience chronic pain, while one-third experience pain severe enough to interfere with their daily lives. Pain in individuals with SCI is divided into two main categories: nociceptive pain and neuropathic pain. Nociceptive pain is defined as pain that occurs when sensory receptors in peripheral nerves detect and encode noxious stimuli, while neuropathic pain is defined as pain that occurs as a result of a lesion or disease of the somatosensory nervous system. The classification of pain types is made both by the spinal cord injury pain classification developed by the International Association for the Study of Pain (IASP) and its successors. However, clinical expertise is required to apply these classifications correctly. For this reason, various screening tools have been developed over the years to more easily distinguish between neuropathic pain and non-neuropathic pain. These tools are usually based on a combination of physical examination findings and self-report or on self-report alone. However, existing tools have generally been evaluated with samples with heterogeneous etiologies and have been found to have lower accuracy rates in individuals with spinal cord injury.
In response to the need for a screening tool that is both sensitive and specific to distinguish neuropathic pain in individuals with SCI, the Spinal Cord Injury Pain Scale (SCIAS) was developed. This tool consists of seven features developed in light of clinical experience and literature analysis to distinguish neuropathic pain. These features include pain descriptions, pain triggered by dynamic touch, factors that increase and decrease pain, timing of pain, and pain felt in sensitive areas. Although the SCIAS has similar features to other pain screening tools, it has the potential to better distinguish the specific nature of pain associated with SCI.
The SCIAS, which was developed in English, has been translated into Chinese, French, and Portuguese. A Turkish version is needed. This study aimed to examine the reliability and validity of the Turkish version of the SCIAS.
- Conditions
- Neuropathic Pain, Spinal Cord Injury
- Being tested
- Evaluation Group
- Keywords
- Neuropathic pain, Psychometric properties, Spinal cord injury pain instrument
- Medical subject headings
- Neuralgia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation GroupOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start28 May 2025 (estimated)
- Primary completion28 Jun 2025 (estimated)
- Study completion28 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990243
- Sponsor's protocol ID
- 15
- Status last verified
- May 2025
- First submitted
- 19 Apr 2025
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tutuneken YE, Elbasi ND. Cross-cultural adaptation, validation, and reliability of the Turkish version of the spinal cord injury Pain Instrument. J Spinal Cord Med. 2026 Jul 13:1-8. doi: 10.1080/10790268.2026.2687278. Online ahead of print.
PubMed 42440306
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Spinal Cord Injury Pain Instrument
- ClinicalTrials.gov ID
- NCT06990243
- Acronym / sponsor ID
- 15
- Conditions
- Neuropathic Pain, Spinal Cord Injury
- Keywords
- Neuropathic pain, Psychometric properties, Spinal cord injury pain instrument
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 28 May 2025 (estimated)
- Primary completion
- 28 Jun 2025 (estimated)
- Study completion
- 28 Jul 2025 (estimated)
- First posted
- 25 May 2025 (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.
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.
Detailed description
Pain after spinal cord injury (SCI) is a common problem. Approximately 80% of individuals with SCI experience chronic pain, while one-third experience pain severe enough to interfere with their daily lives. Pain in individuals with SCI is divided into two main categories: nociceptive pain and neuropathic pain. Nociceptive pain is defined as pain that occurs when sensory receptors in peripheral nerves detect and encode noxious stimuli, while neuropathic pain is defined as pain that occurs as a result of a lesion or disease of the somatosensory nervous system. The classification of pain types is made both by the spinal cord injury pain classification developed by the International Association for the Study of Pain (IASP) and its successors. However, clinical expertise is required to apply these classifications correctly. For this reason, various screening tools have been developed over the years to more easily distinguish between neuropathic pain and non-neuropathic pain. These tools are usually based on a combination of physical examination findings and self-report or on self-report alone. However, existing tools have generally been evaluated with samples with heterogeneous etiologies and have been found to have lower accuracy rates in individuals with spinal cord injury.
In response to the need for a screening tool that is both sensitive and specific to distinguish neuropathic pain in individuals with SCI, the Spinal Cord Injury Pain Scale (SCIAS) was developed. This tool consists of seven features developed in light of clinical experience and literature analysis to distinguish neuropathic pain. These features include pain descriptions, pain triggered by dynamic touch, factors that increase and decrease pain, timing of pain, and pain felt in sensitive areas. Although the SCIAS has similar features to other pain screening tools, it has the potential to better distinguish the specific nature of pain associated with SCI.
The SCIAS, which was developed in English, has been translated into Chinese, French, and Portuguese. A Turkish version is needed. This study aimed to examine the reliability and validity of the Turkish version of the SCIAS.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with spinal cord injuries
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Having major depression
- Having suicidal intent or plans
- Being currently addicted to alcohol or drugs
- Not taking stable doses of psychoactive medications
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 |
|---|---|---|
| Evaluation GroupAn 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). | Other | – |
Primary outcome
The Spinal Cord Injury Pain Instrument (SCIPI)
Time frame: 1 week
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.
DN4 Questionnaire
Time frame: 1 week
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.
Visual Analog Scale
Time frame: 1 week
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 42440306Tutuneken YE, Elbasi ND. Cross-cultural adaptation, validation, and reliability of the Turkish version of the spinal cord injury Pain Instrument. J Spinal Cord Med. 2026 Jul 13:1-8. doi: 10.1080/10790268.2026.2687278. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Spinal Cord Injury, run by Istinye University.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
The Spinal Cord Injury Pain Instrument (SCIPI) (time frame: 1 week). 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?
On the ClinicalTrials.gov record for NCT06990243, which also lists 1 linked publication.
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 25 May 2025.