Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/10/2017
Date assigned
24/01/2018
Last edited
24/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Lots of research shows that large numbers of people have pain that lasts longer than three months. Treatments such as drugs or surgery do not provide relief for this chronic pain condition. For many of the people concerned, the inability to find a cure for the pain can lead to disability, depression and anxiety. Psychological therapies such as cognitive behavioural therapy (a type of talking therapy), can help people to cope with their disability and distress despite continuing pain. These pain management treatments are mainly delivered face-to-face but many people with chronic pain cannot obtain them because of the scarcity of treatment centres. People don’t always live close to a treatment centre and sometimes the cost and discomfort of such a journey prevents them from availing of these treatments. More recently, psychological therapies have been developed for delivery over the internet. This allows people to receive treatment in their own home. This research examines how well an online treatment, called the Pain Course, works for a group of people with chronic pain, who live in Ireland. The Course was developed at, and is managed from Macquarie University, in Sydney, Australia. It aims to provide information and teach practical skills to help manage chronic pain, low mood and anxiety. Research shows that having good information about pain and how to manage it can make a difference in how much pain affects peoples' lives. Results from Australia found that most people who completed the Pain Course showed improvements in their pain symptoms and levels of disability. A majority of people also reported improvements in their emotional wellbeing. The aim of this study is to apply the research to an Irish setting.

Who can participate?
Adults aged 18 and older who have chronic pain for at least six months.

What does the study involve?
Participants are allocated to one of two groups. Those in the first group have immediate access to the Pain Course. Those in the second group receive treatment as usual and join a waiting list, and obtain access to the Course after the Treatment Group complete the course. The pain course includes online lessons over eight weeks, homework with each lessons, case studies based on previous participation, additional resources and weekly contact with a clinician. Participants are followed up with questionnaires before, during and after the course to monitor their symptoms and safety.

What are the possible benefits and risks of participating?
Benefits to the participants include access to a free online psychological CBT programme and useful information on chronic pain. It is expected that participants will experience improvements in coping with their pain and in feelings of wellbeing. By using techniques taught in this programme, it is hoped that participants will find it easier to manage their symptoms.

Where is the study run from?
The study is administered from the Centre for Pain Research, NUI Galway (Ireland) and the eCentre Clinic, Macquarie University (Australia).

When is the study starting and how long is it expected to run for?
November 2016 to May 2018

Who is funding the study?
NUI Galway (Ireland)

Who is the main contact?
1. Ms Catherine Navin (Public)
2. Professor Brian McGuire (Scientific)

Trial website

Contact information

Type

Public

Primary contact

Ms Catherine Navin

ORCID ID

Contact details

Centre for Pain Research
School of Psychology
Arts Millenium Building Extension
NUI Galway
Galway
N/A
Ireland

Type

Scientific

Additional contact

Prof Brian McGuire

ORCID ID

http://orcid.org/0000-0002-3540-6639

Contact details

Centre for Pain Research
School of Psychology
Arts Millenium Building Extension
NUI Galway
Galway
N/A
Ireland

Type

Scientific

Additional contact

Dr Blake F. Dear

ORCID ID

Contact details

Department of Psychology
Macquarie University
New South Wales
Sydney
2109
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

Individuals in the intervention group will report significant improvements on measures of disability, depression, anxiety, and pain severity relative to the control group, together with a high level of satisfaction with the Course.

Ethics approval

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

Study design

Randomised controlled cross over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Chronic Pain

Intervention

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.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

1. Symptoms and severity of depression is measured using the Patient Health Questionnaire – 9 Item (PHQ-9) at baseline, weekly, post-intervention (week 9) and three months post-intervention
2. Symptoms of anxiety is measured using the Generalized Anxiety Disorder Scale – 7 Item (GAD-7) at baseline, post-intervention (week 9) and three months post-intervention
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) and three months post-intervention
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) and three months post-intervention
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) and three months post-intervention
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) and three months post-intervention
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) and three months post-intervention
8. Treatment satisfaction and acceptability is measured using Treatment Satisfaction Questionnaire (TSQ) at post-intervention (week 9)

Overall trial start date

24/11/2016

Overall trial end date

14/05/2018

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total of 140 participants will be recruited with 70 in each group.

Participant exclusion criteria

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

Recruitment start date

08/08/2017

Recruitment end date

16/10/2017

Locations

Countries of recruitment

Ireland

Trial participating centre

NUI Galway
Centre for Pain Research
Galway
N/A
Ireland

Trial participating centre

Macquarie University
Sydney
-
Australia

Sponsor information

Organisation

NUI Galway

Sponsor details

University Road
Galway
N/A
Ireland

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

NUI Galway

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The findings of the trial will be submitted for publication in peer-reviewed journals and will be disseminated through conference presentations.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. Participant data will be anonymized i.e. each participant will be assigned a specific number. All data will be stored in a password protected Microsoft Excel spreadsheet on a password protected and restricted-access clinical network drive, which is secured.

Intention to publish date

14/05/2019

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes