Clinical trial NCT03718702: The Effectiveness of an Electronic Pain Management Programme (ePain) for Working Population With Chronic Pain
Official title: The Effectiveness of an Electronic Pain Management Programme (ePain) for Working Population With Chronic Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Working population
Online learning
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 148
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain self-efficacy
timeFrame: Baseline, Week 3, Week 6 and Week 12
Secondary outcomes:
measure: Pain situations
timeFrame: Baseline, Week 3, Week 6 and Week 12
measure: Negative emotions
timeFrame: Baseline, Week 6 and Week 12
measure: Changes in level of quality of life
timeFrame: Baseline, Week 6 and Week 12
measure: Feedback
timeFrame: Week 6
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: School of Nursing
state: Kowloon
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Mimi Tse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.