Neuropathic Pain, Nociceptive PainPDQMNCT05687175
Translation and Validation of Malay Version of painDETECT Questionnaire
An observational study of Neuropathic Pain, Nociceptive Pain, run by University Malaysia Sarawak at 4 sites in Malaysia.
Trial summary
The translation and cultural adaptation process of the English version of PDQ will be performed based on international guidelines. Subsequently, patients with neuropathic and nociceptive pain based on clinician's diagnoses will be recruited to complete three-type numeric rating scale (NRS) of pain followed by PDQ-M… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Nociceptive Pain
- What is being tested?
- Questionnaire
- How many people
- 97 participants
- Where
- 4 sitesMalaysia
- Study dates
- 1 Feb 2020to 30 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been diagnosed to have neuropathic or nociceptive pain by clinicians, with stable disease condition and pain duration of at least 4 weeks prior to recruitment.
Who may be able to join
- able to read and understand the Malay language
- diagnosed to have neuropathic or nociceptive pain by clinician
- stable disease condition
- pain duration of at least 4 weeks
Who cannot join
- acute illness
- poor mental health status that prevents them from understanding or responding to the proposed questions
- cultural or language barrier
Trial locations and contacts
4 sites in 1 country.
Malaysia4 sites
Sarawak General Hospital
Kuching
Malacca General Hospital
Malacca
Penang General Hospital
Pulau Pinang, Pulau Pinang
Putrajaya Hospital
Putrajaya
About this study
Official title: Study to Translate and Determine the Validity and Reliability of Malay Version of painDETECT Questionnaire (PDQ-M)
The translation and cultural adaptation process of the English version of PDQ will be performed based on international guidelines. Subsequently, patients with neuropathic and nociceptive pain based on clinician's diagnoses will be recruited to complete three-type numeric rating scale (NRS) of pain followed by PDQ-M and SF-36 questionnaire. Patients' socio-demographic data and clinical characteristics will be reported using frequency for categorical variables and mean with standard deviation for continuous variables. Normality will be assessed using Shapiro Wilk test and histograms for continuous variables. Data will be compared between groups using chi-square test (for categorical variables) and t-test or Mann-Whitney's U test (for continuous variables). Suitability of PDQ-M data for factor analysis will be verified using the Bartlett's test of sphericity and the Kaiser-Mayer-Olkin (KMO) measure of sampling adequacy. Parallel analysis will performed to obtain the suitable factors. Construct validity will be investigated by exploratory factorial analysis (EFA) with varimax rotation. A factor loading of >0.40 will be used to determine the items for each factor. The internal consistency of the questionnaire will be assessed using Cronbach's alpha test. A p value of <0.05 is taken as statistically significant.
- Conditions
- Neuropathic Pain, Nociceptive Pain
- Being tested
- Questionnaire
- Medical subject headings
- Neuralgia, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire administration (PDQ-M, NRS, SF-36)
| Study group | Role | What they receive |
|---|---|---|
| Neuropathic pain | Questionnaire administration and socio-demographic data collection Receives: Other: Questionnaire | |
| Nociceptive pain | Questionnaire administration and socio-demographic data collection Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDQ-M scores
Total of PDQ-M scores
Measured: 2-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Feb 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Pain, Nociceptive PainStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Malaysia Sarawak
- Sponsor type
- University, hospital or other
- Collaborators
- Persatuan Diabetes Malaysia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687175
- Sponsor's protocol ID
- PDQ-M
- Acronym
- PDQM
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Translate and Determine the Validity and Reliability of Malay Version of painDETECT Questionnaire (PDQ-M)
- ClinicalTrials.gov ID
- NCT05687175
- Acronym / sponsor ID
- PDQM / PDQ-M
- Conditions
- Neuropathic Pain, Nociceptive Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University Malaysia SarawakUniversity, hospital or other
- Collaborators
- Persatuan Diabetes Malaysia
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Jan 2023 (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.
The translation and cultural adaptation process of the English version of PDQ will be performed based on international guidelines. Subsequently, patients with neuropathic and nociceptive pain based on clinician's diagnoses will be recruited to complete three-type numeric rating scale (NRS) of pain followed by PDQ-M and SF-36 questionnaire. Patients' socio-demographic data and clinical characteristics will be reported using frequency for categorical variables and mean with standard deviation for continuous variables. Normality will be assessed using Shapiro Wilk test and histograms for continuous variables. Data will be compared between groups using chi-square test (for categorical variables) and t-test or Mann-Whitney's U test (for continuous variables). Suitability of PDQ-M data for factor analysis will be verified using the Bartlett's test of sphericity and the Kaiser-Mayer-Olkin (KMO) measure of sampling adequacy. Parallel analysis will performed to obtain the suitable factors. Construct validity will be investigated by exploratory factorial analysis (EFA) with varimax rotation. A factor loading of >0.40 will be used to determine the items for each factor. The internal consistency of the questionnaire will be assessed using Cronbach's alpha test. A p value of <0.05 is taken as statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuropathic pain | – | Other: QuestionnaireQuestionnaire administration and socio-demographic data collection |
| Nociceptive pain | – | Other: QuestionnaireQuestionnaire administration and socio-demographic data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed to have neuropathic or nociceptive pain by clinicians, with stable disease condition and pain duration of at least 4 weeks prior to recruitment.
Key inclusion criteria (4 listed)
- able to read and understand the Malay language
- diagnosed to have neuropathic or nociceptive pain by clinician
- stable disease condition
- pain duration of at least 4 weeks
Key exclusion criteria (3 listed)
- acute illness
- poor mental health status that prevents them from understanding or responding to the proposed questions
- cultural or language barrier
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 |
|---|---|---|
| QuestionnaireQuestionnaire administration (PDQ-M, NRS, SF-36) | Other | Neuropathic pain, Nociceptive pain |
Primary outcome
PDQ-M scores
Time frame: 2-5 weeks
Total of PDQ-M scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
Related trials for Neuropathic Pain, Nociceptive Pain
Not yet recruitingEarly Phase 1
S1R Imaging-Based Cryoneurolysis in Chronic Pain
Chronic Pain, Mixed Pain (Nociceptive and Neuropathic)
Not yet recruitingPhase 2
Functional Brain MRI to Understand Pain Phenotypes in Knee Osteoarthritis
Gonarthrosis, Neuropathic Pain, Nociceptive Pain
RecruitingObservational study
Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury
Spinal Cord Injuries, Pain, Neuropathic
Not yet recruitingObservational study
Pleasant Touch Perception in Persistent Pain.
Chronic Pain, Persistent Pain
Active, not recruitingObservational study
Central Sensitisation in Nociceptive and Neuropathic Pain
Chronic Pain, Nociceptive Pain
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, Nociceptive Pain, run by University Malaysia Sarawak at 4 sites in Malaysia.
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 3 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: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PDQ-M scores (time frame: 2-5 weeks). 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 18 Jan 2023.