Clinical trial NCT03150017: An Internet-Delivered Pain Management Programme for Spinal Cord Injury Pain
Official title: The Impact of an Internet-Delivered Cognitive Behavioural Therapy Pain Management Programme (PMP) on People With Spinal Cord Injuries: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain, Widespread
Spinal Cord Injuries
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Health Informatics Society of Ireland
name: Irish Society of Chartered Physiotherapists
First posted: 2017-05-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To establish the effectiveness of an internet-delivered cognitive behavioural therapy pain management programme (CBT-PMP) on people with spinal cord injury pain compared with usual care.

Detailed description: A pilot prospective, single blinded, randomised controlled trial with two arms an internet-delivered CBT-PMP for chronic pain post spinal cord injury (SCI) and usual care.

The CBT-PMP will contain 8 sessions over 8 weeks, with outcomes assessed at baseline, post intervention, and 6 months follow-up.

Participants will be adults with chronic pain (pain \> 3 months), regular internet access and not undergoing any other psychological treatments.

Following the study those in the intervention strand will be invited to complete a focus group to explore the subjects' overall experience of the online CBT-PMP.

Eligibility criteria: Inclusion Criteria:

* Traumatic or non-traumatic SCI
* Chronic SCI pain of more than three months.
* Discharged from acute hospital and rehabilitation services.
* Males/Females \>18years.
* Regular computer and Internet access and working knowledge of the internet.
* Fluency in English (verbal and written).

Exclusion Criteria:

* Those who have completed a PMP before
* Mental health issue which requiring psychiatric management.
* Acute injury, currently under specialist medical care.
* Patients with confounding co-morbidities such as cancer, unstable angina / uncontrolled cardiac arrhythmias/ severe aortic stenosis, acute systemic infection accompanied by fever, systemic/inflammatory diseases eg rheumatoid arthritis/substance abuse/significant mental health issues.

Primary outcomes:
measure: Quality of life
timeFrame: Change from baseline to six weeks and three months.
Secondary outcomes:
measure: Sleep
timeFrame: Change from baseline to six weeks and three months.
measure: Mood
timeFrame: Change from baseline to six weeks and three months.
measure: Pain
timeFrame: Change from baseline to six weeks and three months.
measure: Pain interference
timeFrame: Change from baseline to six weeks and three months.
measure: Pain acceptance
timeFrame: Change from baseline to six weeks and three months.
measure: Patients impression of change
timeFrame: Change from baseline to six weeks and three months.
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: School of Public Health Physiotherapy and Sports Science
Study officials:
References: