Neuropathic PainNCT02450565
Translation of the Self Completed-Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale
An observational study of Neuropathic Pain and Chronic Pain, run by The University of Hong Kong.
Trial summary
Neuropathic pain, described as 'pain arising as a direct consequence of a lesion or disease on the somatosensory system', affects up to 3-9.8% of the investigators' population, but is often underdiagnosed and undertreated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain, Chronic Pain, Nociceptive Pain
- What is being tested?
- Questionnaire
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jun 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 200 pain patients will be recruited. One hundred of these patients will be patients suffering from neuropathic pain, and 100 will be patients with nociceptive pain. The diagnosis of neuropathic or nociceptive pain will be made by pain specialists based on a detailed history, physical examination, investigation results and medical records. The pain specialists' diagnosis will be used for distinguishing between nociceptive and neuropathic pain. Demographic information including age, sex, pain diagnosis and duration, education level, co-existing medical problems and employment status will be recorded. The Cantonese S-LANSS will then be administered to patients to be completed without the help of staff.
Who may be able to join
- Native Chinese-Cantonese speaker
- Aged 18 to 80
- Presence of pain for more than 3 months
- Able to understand, read and write Traditional Chinese
- Able to give informed written consent
- Ability to complete the questionnaire
Who cannot join
- Patients who require active pain treatment and / or intervention within 1 week after the initial consultation
- Voluntary withdrawal from study at any stage
About this study
Official title: Translation and Validation of the Traditional Chinese-Cantonese Version of the Self Completed-Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale
Neuropathic pain, described as 'pain arising as a direct consequence of a lesion or disease on the somatosensory system', affects up to 3-9.8% of the investigators' population, but is often underdiagnosed and undertreated. As treatment is different for patients with neuropathic pain and nociceptive pain, it is important to screen for neuropathic pain. Commonly employed questionnaire-based diagnostic tools in English speaking countries include the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS) and Neuropathic pain questionnaire (NPQ). Self-completed LANSS is particularly useful as it is not restricted to clinician's examination and can be applied in large-scale research. S-LANSS has been successfully translated, validated and used successfully in Arabic and Turkish, but it has not been utilised in the Chinese population. As verbal translations of the English questionnaires used at the bedside may be prone to errors in interpretation and requires medical practitioners to interpret the questions. Therefore a translation and validation study is essential.
- Conditions
- Neuropathic Pain, Chronic Pain, Nociceptive Pain
- Being tested
- Questionnaire
- Medical subject headings
- Neuralgia, Chronic Pain, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Neuropathic pain subjects | The diagnosis of neuropathic pain will be made by pain specialists based on a detailed history, physical examination, investigation results and medical records. Receives: Other: Questionnaire | |
| Nociceptive pain subjects | The diagnosis of nociceptive pain will be made by pain specialists based on a detailed history, physical examination, investigation results and medical records. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire can successfully identify subjects with neuropathic pain, or nociceptive pain
Measured: One year from commencement of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (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.
- More trials run by The University of Hong KongThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Choi Siu-wai, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450565
- Sponsor's protocol ID
- Neuropathic Pain Translation
- Status last verified
- May 2015
- First submitted
- 19 May 2015
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the Traditional Chinese-Cantonese Version of the Self Completed-Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale
- ClinicalTrials.gov ID
- NCT02450565
- Acronym / sponsor ID
- Neuropathic Pain Translation
- Conditions
- Neuropathic Pain, Chronic Pain, Nociceptive Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 21 May 2015 (estimated)
- 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.
Neuropathic pain, described as 'pain arising as a direct consequence of a lesion or disease on the somatosensory system', affects up to 3-9.8% of the investigators' population, but is often underdiagnosed and undertreated. As treatment is different for patients with neuropathic pain and nociceptive pain, it is important to screen for neuropathic pain. Commonly employed questionnaire-based diagnostic tools in English speaking countries include the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS) and Neuropathic pain questionnaire (NPQ). Self-completed LANSS is particularly useful as it is not restricted to clinician's examination and can be applied in large-scale research. S-LANSS has been successfully translated, validated and used successfully in Arabic and Turkish, but it has not been utilised in the Chinese population. As verbal translations of the English questionnaires used at the bedside may be prone to errors in interpretation and requires medical practitioners to interpret the questions. Therefore a translation and validation study is essential.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuropathic pain subjects | – | Other: QuestionnaireThe diagnosis of neuropathic pain will be made by pain specialists based on a detailed history, physical examination, investigation results and medical records. |
| Nociceptive pain subjects | – | Other: QuestionnaireThe diagnosis of nociceptive pain will be made by pain specialists based on a detailed history, physical examination, investigation results and medical records. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 200 pain patients will be recruited. One hundred of these patients will be patients suffering from neuropathic pain, and 100 will be patients with nociceptive pain. The diagnosis of neuropathic or nociceptive pain will be made by pain specialists based on a detailed history, physical examination, investigation results and medical records. The pain specialists' diagnosis will be used for distinguishing between nociceptive and neuropathic pain. Demographic information including age, sex, pain diagnosis and duration, education level, co-existing medical problems and employment status will be recorded. The Cantonese S-LANSS will then be administered to patients to be completed without the help of staff.
Key inclusion criteria (6 listed)
- Native Chinese-Cantonese speaker
- Aged 18 to 80
- Presence of pain for more than 3 months
- Able to understand, read and write Traditional Chinese
- Able to give informed written consent
Key exclusion criteria (2 listed)
- Patients who require active pain treatment and / or intervention within 1 week after the initial consultation
- Voluntary withdrawal from study at any stage
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 |
|---|---|---|
| Questionnaire | Other | Neuropathic pain subjects, Nociceptive pain subjects |
Primary outcome
Questionnaire can successfully identify subjects with neuropathic pain, or nociceptive pain
Time frame: One year from commencement of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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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.
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 Chronic Pain, run by The University of Hong Kong.
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 6 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 21 May 2015. 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?
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?
Questionnaire can successfully identify subjects with neuropathic pain, or nociceptive pain (time frame: One year from commencement of study). 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 21 May 2015.