- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02450565
Translation of the Self Completed-Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale
May 20, 2015 updated by: Dr. Choi Siu-wai, The University of Hong Kong
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
200
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who require active pain treatment and / or intervention within 1 week after the initial consultation
- Voluntary withdrawal from study at any stage
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Questionnaire can successfully identify subjects with neuropathic pain, or nociceptive pain
Time Frame: One year from commencement of study
|
One year from commencement of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Anticipated)
June 1, 2016
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
May 19, 2015
First Submitted That Met QC Criteria
May 20, 2015
First Posted (Estimate)
May 21, 2015
Study Record Updates
Last Update Posted (Estimate)
May 21, 2015
Last Update Submitted That Met QC Criteria
May 20, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Neuropathic Pain Translation
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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