The Pain Course: Examining the effectiveness of an online chronic pain management programme, in adults with chronic pain, living in Ireland

• Register: ISRCTN
• Last refreshed on: 22 June 2020
• Main ID: ISRCTN11292570
• Date of registration: 24/01/2018
• Prospective Registration: No
• Primary sponsor: NUI Galway
• Public title: The Pain Course: Examining the effectiveness of an online chronic pain management programme, in adults with chronic pain, living in Ireland
• Scientific title: A randomized controlled trial (RCT) of the Pain Course, an internet-based chronic pain management programme, in adults with chronic pain, living in Ireland
• Date of first enrolment: 08/08/2017
• Target sample size: 140
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11292570
• Study type: Interventional
• Study design: Randomised controlled cross over trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Ireland

Contacts

• Name: Catherine Navin

• Name: Brian McGuire

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 18 years or older
2. The presence of chronic pain for at least 6 months duration
3. Resident of Ireland
5. Sufficient computer and internet literacy/have internet access
6. Not currently experiencing an unmanaged psychotic illness or severe symptoms of depression (indicated by a total score > 22, or a score > 2 on item 9 of the PHQ-9)

Exclusion criteria:
1. Chronic pain due to malignancy
2. Person unable to engage with the treatment intervention due to insufficient English language


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Pain
Injury, Occupational Diseases, Poisoning
Chronic Pain

Intervention(s)

This study involves a collaboration between researchers at NUI Galway and a research team at the eCentreClinic at MacQuarie University, Sydney, who developed the Pain Course. The programme comprises a secure web platform, assessment procedures, and treatment content, and is maintained at the eCentreClinic.

Intervention:
The Pain Course comprises:
1. Five online lessons provided over 8 weeks
2. A homework summary with assignments for each lesson
3. Additional resources which deal with topics and skills that are potentially relevant for the participants, such as managing sleep, problem solving, and assertive communication
4. Case Studies based on previous participants
5. Weekly contact with a clinician via email or telephone

Individuals who are selected for the trial are randomly allocated to receive the Pain Course or to a treatment-as-usual waitlist control condition, who receive the course after the Active Treatment Group has finished. The randomisation process is carried out through the generation of a list of random numbers, using an independent website, www.random.org, corresponding to the two groups.

All data is collected online via the eCentreClinic secure software platform. Participants are asked to complete questionnaires prior to starting the Course (pre-treatment), nine weeks after starting the Course, and three months post-intervention.

Primary Outcome(s)

1. Disability associated with chronic pain is measured using the Roland Morris Disability Questionnaire (RMDQ) at baseline, post-intervention (week 9), 3 months post-intervention and 2-year follow-up

Updated 27/03/2020 to add 2-year follow-up

Secondary Outcome(s)

1. Symptoms and severity of depression is measured using the Patient Health Questionnaire – 9 Item (PHQ-9) at baseline, weekly, post-intervention (week 9), 3 months post-intervention and 2-year follow-up
2. Symptoms of anxiety is measured using the Generalized Anxiety Disorder Scale – 7 Item (GAD-7) at baseline, post-intervention (week 9), 3 months post-intervention and 2-year follow-up
3. Duration, severity and location of a person’s pain as well as level of interference associated with pain is measured using the Wisconsin Brief Pain Questionnaire (WBPQ) at baseline, post-intervention (week 9), 3 months post-intervention and 2-year follow-up
4. A person’s beliefs about their ability to undertake a number of daily tasks with pain is measured using the Pain Self-Efficacy Questionnaire (PSEQ) at baseline, post-intervention (week 9), 3 months post-intervention and 2-year follow-up
5. A person’s fear of movement and re-injury is measured using the Tampa Scale of Kinesiophobia (TSK) at baseline, post-intervention (week 9), 3 months post-intervention and 2-year follow-up
6. A person’s acceptance in the context of chronic pain is measured using the Chronic Pain Acceptance Questionnaire (CPAC) at baseline, post-intervention (week 9), 3 months post-intervention and 2-year follow-up
7. Pain severity and impact on health-related quality of life (HRQOL) domains is measured using the Pain Impact Questionnaire (PIQ-6) at baseline, post-intervention (week 9), 3 months post-intervention and 2-year follow-up
8. Treatment satisfaction and acceptability is measured using Treatment Satisfaction Questionnaire (TSQ) at post-intervention (week 9), and 2-year follow-up
9. Post Traumatic Stress Disorder (PTSD) and Complex PTSD measured using Complex Trauma Inventory (CTI) at 2-year follow-up (added 27/03/2020)

Updated 27/03/2020 to add 2-year follow-up

Secondary ID(s)

N/A

Source(s) of Monetary Support

NUI Galway

Ethics review

Status:
Approval date:
Contact:

1. NUI Galway Research Ethic Committee, 20/03/2017, ref: 17-March-27 2. Macquarie University HREC, 14/07/2017, ref: 5201700731

Results

• Results available: Yes
• Date Completed: 14/05/2020