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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain
• Intervention / Treatment: Other: ePain

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 Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon
    • Hung Hom, Kowloon, Hong Kong
      • School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 61 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; ePain will be accessible by the intervention group.	Other: ePain; Electronic pain management programme (ePain)
No Intervention: Control group; No intervention will be applied to control group and they can download an educational pamphlet only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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	Week 6

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Mimi Tse, PhD, The Hong Kong Polytechnic University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Chronic pain; Online learning; Working population
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: ePain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No