Chronic PainNCT02513251
Chinese-Cantonese Version of Short Form McGill Pain Questionnaire Validation
An observational study of Chronic Pain, run by The University of Hong Kong at 1 site in China.
Trial summary
Pain is defined as "An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage." In particular, chronic pain has significant impact on health care cost and socio-economic aspects of the society. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Chronic pain
- How many people
- 241 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2015to 31 Jul 2023
- 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: Chronic pain patients from the Pain Clinic in Queen Mary Hospital
Who may be able to join
- Native Chinese-Cantonese speaker
- Aged 18 or above
- Presence of chronic pain for more than 3 months
- Able to understand, read and write Traditional Chinese
- Mentally capable to give informed written consent
- Ability to complete the questionnaires
Who cannot join
- Non-native Chinese-Cantonese speaker
- Aged below 18
- Unable to read or write Traditional Chinese
- Presence of chronic pain for less than 3 months
- Mentally incapable to give informed written consent
- Unable to complete the questionnaires
- Patients who require active pain treatment and / or intervention within 2 weeks after the initial consultation
- Voluntary withdrawal from study at any stage
Trial locations and contacts
1 site in 1 country.
China1 site
Deaprtment of Anaesthesiology, The University of Hong Kong
Hong Kong
About this study
Official title: Validation of the Traditional Chinese-Cantonese Version of Short Form McGill Pain Questionnaire (C-SF-MPQ-2)
Pain is defined as "An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage." In particular, chronic pain has significant impact on health care cost and socio-economic aspects of the society. It is clear that the development of effective chronic pain management is paramount in reducing the significant socio-economic burden of this common healthcare problem.
One of the difficulties in measuring outcomes in chronic pain patients is the subjective nature of pain. The McGill Pain Questionnaire (MPQ) was developed in 1975 with the aim of quantifying the subjective pain experiences of patients. Since then it has become one of the major assessment tools in evaluation of chronic pain patients during the course of treatments. The Short Form McGill Pain Questionnaire (SF-MPQ) developed in 1987 has further refined pain descriptors into "sensory" and "affective" domains, and incorporating the Visual Analog Scale (VAS) for easier administration in hospitals and clinics. The validity and reliability of both the original English and translated versions of MPQ and SF-MPQ have been well demonstrated. The latest version of Short Form McGill Pain Questionnaire (SF-MPQ-2) included descriptive terms for neuropathic pain which expanded the scope of coverage on chronic neuropathic pain patients. It has also been evaluated in cancer pain patients. Translated versions of SF-MPQ-2 showed good reliability and validity. Therefore the investigators devised this study to (1) translate SF-MPQ-2 into Traditional Chinese-Cantonese (C-SF-MPQ-2) suitable for use in Hong Kong patients, (2) examine the validity, reliability and psychometric properties of this translated version in Hong Kong patients.
Read the detailed description
Objectives of this trial
- To validate the C-SF-MPQ-2 among chronic pain patients in Hong Kong.
- To evaluate the validity, reliability and psychometric properties of the C-SF-MPQ-2 as an assessment tool for measuring pain.
Trial design Prospective non-randomized trial with self-administered questionnaire in chronic pain patients.
Methods The study will be carried out in 2 phases (I and II). Phase I refers to the translation process and phase II refers to the validation process.
Since this study will be carried out at 2 pain centres (Hong Kong West Cluster Pain Management Centre and Kowloon East Cluster Pain Management Centre), approvals from Ethics Committee of Hong Kong West Cluster and Kowloon East Cluster will be obtained.
(I) Translation of the original English version of SF-MPQ-2 into Traditional Chinese-Cantonese version (C-SF-MPQ-2) Forward translation shall be done by one pain specialist and one lay person with linguistic background. Both shall be native Chinese-Cantonese speaker with proficiency in English. Each translator shall produce a translated version independently. Afterwards the principle investigator will co-ordinate with both translators to come up with one commonly agreed translated version (version 1).
Backward translation shall be done by one pain specialist who is a native English speaker with proficiency in Chinese-Cantonese (version 2). This will be compared to the original questionnaire. The principle investigator will discuss with all the translators on any discrepancy between version 2 and the original version and make necessary adjustments to version 1 to produce a revised version (version 3).
The translated version 3 will then be tested on 5 randomly selected chronic pain patients from both pain management centres. They shall be native Chinese-Cantonese speakers. Consent will be obtained beforehand. An interviewer will inquire whether patients have any difficulty on completing the questionnaire or have any suggestions with regard to the translated terms. Any adjustments shall be made after receiving feedback from the interviewer to produce the finalized version (C-SF-MPQ-2).
(II) Validation of C-SF-MPQ-2 A total of 220 chronic pain patients will be recruited for the process of validation. After obtaining consent, basic demographic information including age, sex, pain diagnosis and duration, education level, co-existing medical problems and employment status will be recorded. The C-SF-MPQ-2 will then be administered to patients. For the construct validity, the Chinese versions of Medical Outcome Study Short Form 36 (SF-36), ID-Pain and Pain Catastrophizing Scale (PCS) will be administered at the same time. For the test-retest reliability, the C-SF-MPQ-2 will be administered again after 2 weeks at the pain management centres during which patients should not receive any alternation in their pain management or intervention. Patients' data privacy and confidentiality will be ensured during the entire process of study.
- Conditions
- Chronic Pain
- Being tested
- Chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic painOther
Chronic pain patients would complete the Traditional Chinese-Cantonese version of Short Form McGill Pain Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Case group | Chronic pain patient Receives: Other: Chronic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-SF-MPQ-2 score
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study start31 Jul 2015
- Primary completion31 May 2021
- Study completion31 Jul 2023
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 Chronic 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
- Other
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chi-Wai Cheung, The University of Hong Kong
- Investigators
- Chi Wai Cheung, MBBS, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513251
- Sponsor's protocol ID
- UW15-013
- Status last verified
- May 2024
- First submitted
- 29 Jul 2015
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tsui FPY, Wong SSC, Chan TCW, Lee Y, Cheung CW. A validation study of the Cantonese Chinese version of short form McGill pain questionnaire 2 in Cantonese-speaking patients with chronic pain in Hong Kong. Pain Pract. 2024 Mar;24(3):449-457. doi: 10.1111/papr.13319. Epub 2023 Nov 17.
PubMed 37975327
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Traditional Chinese-Cantonese Version of Short Form McGill Pain Questionnaire (C-SF-MPQ-2)
- ClinicalTrials.gov ID
- NCT02513251
- Acronym / sponsor ID
- UW15-013
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 31 Jul 2015 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 31 Jul 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.
Pain is defined as "An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage." In particular, chronic pain has significant impact on health care cost and socio-economic aspects of the society. It is clear that the development of effective chronic pain management is paramount in reducing the significant socio-economic burden of this common healthcare problem.
One of the difficulties in measuring outcomes in chronic pain patients is the subjective nature of pain. The McGill Pain Questionnaire (MPQ) was developed in 1975 with the aim of quantifying the subjective pain experiences of patients. Since then it has become one of the major assessment tools in evaluation of chronic pain patients during the course of treatments. The Short Form McGill Pain Questionnaire (SF-MPQ) developed in 1987 has further refined pain descriptors into "sensory" and "affective" domains, and incorporating the Visual Analog Scale (VAS) for easier administration in hospitals and clinics. The validity and reliability of both the original English and translated versions of MPQ and SF-MPQ have been well demonstrated. The latest version of Short Form McGill Pain Questionnaire (SF-MPQ-2) included descriptive terms for neuropathic pain which expanded the scope of coverage on chronic neuropathic pain patients. It has also been evaluated in cancer pain patients. Translated versions of SF-MPQ-2 showed good reliability and validity. Therefore the investigators devised this study to (1) translate SF-MPQ-2 into Traditional Chinese-Cantonese (C-SF-MPQ-2) suitable for use in Hong Kong patients, (2) examine the validity, reliability and psychometric properties of this translated version in Hong Kong patients.
Detailed description
Objectives of this trial
- To validate the C-SF-MPQ-2 among chronic pain patients in Hong Kong.
- To evaluate the validity, reliability and psychometric properties of the C-SF-MPQ-2 as an assessment tool for measuring pain.
Trial design Prospective non-randomized trial with self-administered questionnaire in chronic pain patients.
Methods The study will be carried out in 2 phases (I and II). Phase I refers to the translation process and phase II refers to the validation process.
Since this study will be carried out at 2 pain centres (Hong Kong West Cluster Pain Management Centre and Kowloon East Cluster Pain Management Centre), approvals from Ethics Committee of Hong Kong West Cluster and Kowloon East Cluster will be obtained.
(I) Translation of the original English version of SF-MPQ-2 into Traditional Chinese-Cantonese version (C-SF-MPQ-2) Forward translation shall be done by one pain specialist and one lay person with linguistic background. Both shall be native Chinese-Cantonese speaker with proficiency in English. Each translator shall produce a translated version independently. Afterwards the principle investigator will co-ordinate with both translators to come up with one commonly agreed translated version (version 1).
Backward translation shall be done by one pain specialist who is a native English speaker with proficiency in Chinese-Cantonese (version 2). This will be compared to the original questionnaire. The principle investigator will discuss with all the translators on any discrepancy between version 2 and the original version and make necessary adjustments to version 1 to produce a revised version (version 3).
The translated version 3 will then be tested on 5 randomly selected chronic pain patients from both pain management centres. They shall be native Chinese-Cantonese speakers. Consent will be obtained beforehand. An interviewer will inquire whether patients have any difficulty on completing the questionnaire or have any suggestions with regard to the translated terms. Any adjustments shall be made after receiving feedback from the interviewer to produce the finalized version (C-SF-MPQ-2).
(II) Validation of C-SF-MPQ-2 A total of 220 chronic pain patients will be recruited for the process of validation. After obtaining consent, basic demographic information including age, sex, pain diagnosis and duration, education level, co-existing medical problems and employment status will be recorded. The C-SF-MPQ-2 will then be administered to patients. For the construct validity, the Chinese versions of Medical Outcome Study Short Form 36 (SF-36), ID-Pain and Pain Catastrophizing Scale (PCS) will be administered at the same time. For the test-retest reliability, the C-SF-MPQ-2 will be administered again after 2 weeks at the pain management centres during which patients should not receive any alternation in their pain management or intervention. Patients' data privacy and confidentiality will be ensured during the entire process of study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Chronic painChronic pain patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic pain patients from the Pain Clinic in Queen Mary Hospital
Key inclusion criteria (6 listed)
- Native Chinese-Cantonese speaker
- Aged 18 or above
- Presence of chronic pain for more than 3 months
- Able to understand, read and write Traditional Chinese
- Mentally capable to give informed written consent
Key exclusion criteria (8 listed)
- Non-native Chinese-Cantonese speaker
- Aged below 18
- Unable to read or write Traditional Chinese
- Presence of chronic pain for less than 3 months
- Mentally incapable to give informed written consent
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 |
|---|---|---|
| Chronic painChronic pain patients would complete the Traditional Chinese-Cantonese version of Short Form McGill Pain Questionnaire | Other | Case group |
Primary outcome
C-SF-MPQ-2 score
Time frame: 2 weeks
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 16 May 2024.
- Derived from this study: PubMed 37975327Tsui FPY, Wong SSC, Chan TCW, Lee Y, Cheung CW. A validation study of the Cantonese Chinese version of short form McGill pain questionnaire 2 in Cantonese-speaking patients with chronic pain in Hong Kong. Pain Pract. 2024 Mar;24(3):449-457. doi: 10.1111/papr.13319. Epub 2023 Nov 17.
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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.
Chi Wai Cheung, MBBS, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by The University of Hong Kong at 1 site in China.
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 8 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
C-SF-MPQ-2 score (time frame: 2 weeks). 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 NCT02513251, 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 16 May 2024.