Chronic PainNCT03718702
The Effectiveness of an Electronic Pain Management Programme (ePain) for Working Population With Chronic Pain
A study testing ePain in people with Chronic Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Pain in commonly found in working population. The working population who aged from 15 to 64 is the largest portion of population in Hong Kong. Also, the prevalence of chronic pain in this population group is high. The issue requires special attention. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- ePain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2018to 1 Apr 2022
- Phase
- Interventional
- 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 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults aged 15 to 65;
- Performed a formal job during the seven days before the intervention or worked for pay or profit during the seven days before the intervention;
- Able to read and understand traditional Chinese;
- With non-cancer chronic pain for at least three months;
- With pain scored one or above in the numeric rating scale from zero to ten in the Chinese version of Brief Pain Inventory (BPI-C)
Who cannot join
- Adults aged 15 below or above 65;
- Not performed any formal jobs for pay or profit during the seven days before the intervention;
- With cancer pain or non-cancer acute pain for less than 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of an Electronic Pain Management Programme (ePain) for Working Population With Chronic Pain: A Randomized Controlled Trial
Pain in commonly found in working population. The working population who aged from 15 to 64 is the largest portion of population in Hong Kong. Also, the prevalence of chronic pain in this population group is high. The issue requires special attention. Researches demonstrated pain affects a person in a multidimensional way. Pain induces negative effects to both the physical and psychological aspects. The levels of depression, anxiety, stress are increased and quality of life is decreased in people with chronic pain. They are interrelated to pain. As pain induced discomforts, people adopted self-initiated treatments as treatment. Pharmacological and non-pharmacological pain management interventions are commonly used. Although people used different ways to relieve the pain, they tend to bear the pain to work or take sick leave. This contributes to the work loss to the whole society.
Pain service in Hong Kong is scarce in the public and private sectors. It takes months for a pain sufferer to be arranged for a pain clinic follow-up. It is possible for the pain get worsen while waiting for the pain service. The pain can be difficult to treat afterwards. As self-initiated treatments are welcomed by the pain sufferers, pain education can be focused on empowering the pain sufferers on their pain knowledge and self-management techniques. The pain self-efficacy can be enhanced. The pain sufferers can be benefited from lowering the pain intensity and negative emotions. It can be a solution to develop an online pain management programme to ease the service demand.
Limited studies are found for online pain management programmes to improve the pain self-efficacy and self-management techniques. In order to fill the knowledge gap and service gap, the present study aims to evaluate an online pain management programme (ePain) in improving the self-efficacy, reduction of pain intensity, decreased levels of depression, anxiety and stress, and improving quality of life in pain management in adults with chronic pain. Participants are randomised to the intervention group or the control group.
Read the detailed description
Participants will register in ePain for an individual account. Then they will finish the the pre-test questionnaire. They will be randomized to either the intervention group or control group. ePain will be accessed by the participants in the intervention group. The control group will remain their regular activities. The participants in both groups will need to complete the pre-test (Week 1), process evaluation (Week 3), post-assessment (Week 6) and follow-up assessment (Week 12). Same questionnaire will be used in the assessments. Demographic data will be collected in Week 1. At Week 1, 3, 6 and 12, pain situation and pain self-efficacy will be collected. Data of negative emotions and quality of life will be collected at Week 1, 6 and 12. The control group will undergo the same assessment as the intervention group.
- Conditions
- Chronic Pain
- Being tested
- ePain
- Keywords
- Chronic pain, Working population, Online learning
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePainOther
Electronic pain management programme (ePain)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | ePain will be accessible by the intervention group. Receives: Other: ePain |
| Control group | No intervention | No intervention will be applied to control group and they can download an educational pamphlet only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain self-efficacy
Changes from baseline to Week 3, Week 6 and Week 12 in pain self-efficacy using the Pain Self-Efficacy Questionnaire
Measured: Baseline, Week 3, Week 6 and Week 12
Secondary outcomes (4)
Pain situations
Changes from baseline to Week 3, Week 6 and Week 12 in pain situations using the Chinese version of Brief Pain Inventory (BPI-C)
Measured: Baseline, Week 3, Week 6 and Week 12
Negative emotions
Changes from baseline to Week 6 and Week 12 in depression, anxiety and stress levels using the Depression Anxiety Stress Scale (DASS-21)
Measured: Baseline, Week 6 and Week 12
Changes in level of quality of life
Changes from baseline to Week 6 and Week 12 in quality of life using the World Health Organization Quality of Life Instruments (WHOQOL-BREF)
Measured: Baseline, Week 6 and Week 12
Feedback
Open ended questions developed by the research team to collect comments of using ePain, including the user experience, webpage design, usefulness of ePain and items for improvement
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Nov 2018
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (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 Chronic PainStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSE Mun Yee Mimi, The Hong Kong Polytechnic University
- Investigators
- Mimi Tse, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718702
- Sponsor's protocol ID
- ePain
- Status last verified
- Apr 2020
- First submitted
- 23 Oct 2018
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang SK, Tse MMY, Leung SF, Fotis T. The effectiveness of an electronic pain management programme for the working population with chronic pain: study protocol for a randomized controlled trial. Trials. 2020 May 24;21(1):421. doi: 10.1186/s13063-020-04348-5.
PubMed 32448387
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Electronic Pain Management Programme (ePain) for Working Population With Chronic Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03718702
- Acronym / sponsor ID
- ePain
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Working population, Online learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 24 Oct 2018 (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 in commonly found in working population. The working population who aged from 15 to 64 is the largest portion of population in Hong Kong. Also, the prevalence of chronic pain in this population group is high. The issue requires special attention. Researches demonstrated pain affects a person in a multidimensional way. Pain induces negative effects to both the physical and psychological aspects. The levels of depression, anxiety, stress are increased and quality of life is decreased in people with chronic pain. They are interrelated to pain. As pain induced discomforts, people adopted self-initiated treatments as treatment. Pharmacological and non-pharmacological pain management interventions are commonly used. Although people used different ways to relieve the pain, they tend to bear the pain to work or take sick leave. This contributes to the work loss to the whole society.
Pain service in Hong Kong is scarce in the public and private sectors. It takes months for a pain sufferer to be arranged for a pain clinic follow-up. It is possible for the pain get worsen while waiting for the pain service. The pain can be difficult to treat afterwards. As self-initiated treatments are welcomed by the pain sufferers, pain education can be focused on empowering the pain sufferers on their pain knowledge and self-management techniques. The pain self-efficacy can be enhanced. The pain sufferers can be benefited from lowering the pain intensity and negative emotions. It can be a solution to develop an online pain management programme to ease the service demand.
Limited studies are found for online pain management programmes to improve the pain self-efficacy and self-management techniques. In order to fill the knowledge gap and service gap, the present study aims to evaluate an online pain management programme (ePain) in improving the self-efficacy, reduction of pain intensity, decreased levels of depression, anxiety and stress, and improving quality of life in pain management in adults with chronic pain. Participants are randomised to the intervention group or the control group.
Detailed description
Participants will register in ePain for an individual account. Then they will finish the the pre-test questionnaire. They will be randomized to either the intervention group or control group. ePain will be accessed by the participants in the intervention group. The control group will remain their regular activities. The participants in both groups will need to complete the pre-test (Week 1), process evaluation (Week 3), post-assessment (Week 6) and follow-up assessment (Week 12). Same questionnaire will be used in the assessments. Demographic data will be collected in Week 1. At Week 1, 3, 6 and 12, pain situation and pain self-efficacy will be collected. Data of negative emotions and quality of life will be collected at Week 1, 6 and 12. The control group will undergo the same assessment as the intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: ePainePain will be accessible by the intervention group. |
| Control group | No intervention | –No intervention will be applied to control group and they can download an educational pamphlet only. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 15 to 65;
- Performed a formal job during the seven days before the intervention or worked for pay or profit during the seven days before the intervention;
- Able to read and understand traditional Chinese;
- With non-cancer chronic pain for at least three months;
- With pain scored one or above in the numeric rating scale from zero to ten in the Chinese version of Brief Pain Inventory (BPI-C)
Key exclusion criteria (3 listed)
- Adults aged 15 below or above 65;
- Not performed any formal jobs for pay or profit during the seven days before the intervention;
- With cancer pain or non-cancer acute pain for less than 3 months.
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 |
|---|---|---|
| ePainElectronic pain management programme (ePain) | Other | Intervention group |
Primary outcome
Pain self-efficacy
Time frame: Baseline, Week 3, Week 6 and Week 12
Changes from baseline to Week 3, Week 6 and Week 12 in pain self-efficacy using the Pain Self-Efficacy Questionnaire
4 secondary outcomes
Pain situations
Time frame: Baseline, Week 3, Week 6 and Week 12
Negative emotions
Time frame: Baseline, Week 6 and Week 12
Changes in level of quality of life
Time frame: Baseline, Week 6 and Week 12
Feedback
Time frame: Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Derived from this study: PubMed 32448387Tang SK, Tse MMY, Leung SF, Fotis T. The effectiveness of an electronic pain management programme for the working population with chronic pain: study protocol for a randomized controlled trial. Trials. 2020 May 24;21(1):421. doi: 10.1186/s13063-020-04348-5.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative 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.
Mimi Tse, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePain in people with Chronic Pain, run by The Hong Kong Polytechnic University at 1 site in 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 5 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: status not confirmed, as of the sponsor's last update on 9 Apr 2020. 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 Hong Kong. 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?
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?
Pain self-efficacy (time frame: Baseline, Week 3, Week 6 and Week 12). 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 NCT03718702, 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 9 Apr 2020.