NCT03718702

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
148

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

3.4 years

First QC Date

October 23, 2018

Last Update Submit

April 8, 2020

Conditions

Keywords

Chronic painWorking populationOnline learning

Outcome Measures

Primary Outcomes (1)

  • Pain self-efficacy

    Changes from baseline to Week 3, Week 6 and Week 12 in pain self-efficacy using the Pain Self-Efficacy Questionnaire

    Baseline, Week 3, Week 6 and Week 12

Secondary Outcomes (4)

  • Pain situations

    Baseline, Week 3, Week 6 and Week 12

  • Negative emotions

    Baseline, Week 6 and Week 12

  • Changes in level of quality of life

    Baseline, Week 6 and Week 12

  • Feedback

    Week 6

Study Arms (2)

Intervention group

EXPERIMENTAL

ePain will be accessible by the intervention group.

Other: ePain

Control group

NO INTERVENTION

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

Interventions

ePainOTHER

Electronic pain management programme (ePain)

Intervention group

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing

Hung Hom, Kowloon, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mimi Tse, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 24, 2018

Study Start

November 1, 2018

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

April 9, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations