The Effectiveness of an Electronic Pain Management Programme (ePain) for Working Population With Chronic Pain

NCT ID: NCT03718702

Last Updated: 2020-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2022-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Self-efficacy theory of behavioral change is adopted to guide the conceptual framework and development of the intervention. It was first introduced by Bandura in 1977. In the theory, self-efficacy would increase when a person participates actively in the activities to gain experience. There are two expectations in the model. The efficacy expectations of the person would contribute to the person's behaviour. The person performs the behaviour and would expect the outcomes and this is outcome expectations. The theory has been discussed for how to apply in health promotion. As the theory integrates self-efficacy and self-regulatory elements, people are benefited from the improved health outcomes which is resulted from the health behaviours.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

ePain will be accessible by the intervention group.

Group Type EXPERIMENTAL

ePain

Intervention Type OTHER

Electronic pain management programme (ePain)

Control group

No intervention will be applied to control group and they can download an educational pamphlet only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ePain

Electronic pain management programme (ePain)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* 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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

TSE Mun Yee Mimi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mimi Tse, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Nursing

Hung Hom, Kowloon, Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32448387 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ePain

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.