An Internet-Delivered Pain Management Programme for Spinal Cord Injury Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03150017
• Date of registration: 05/05/2017
• Prospective Registration: No
• Primary sponsor: Dearbhla Burke
• Public title: An Internet-Delivered Pain Management Programme for Spinal Cord Injury Pain
• Scientific title: The Impact of an Internet-Delivered Cognitive Behavioural Therapy Pain Management Programme (PMP) on People With Spinal Cord Injuries: A Pilot Study
• Date of first enrolment: March 8, 2017
• Target sample size: 70
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03150017
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Ireland

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Pain, Widespread

Spinal Cord Injuries

Intervention(s)

Other: SPIRE

Primary Outcome(s)

Quality of life [Time Frame: Change from baseline to six weeks and three months.]

Secondary Outcome(s)

Pain acceptance [Time Frame: Change from baseline to six weeks and three months.]

Pain [Time Frame: Change from baseline to six weeks and three months.]

Mood [Time Frame: Change from baseline to six weeks and three months.]

Patients impression of change [Time Frame: Change from baseline to six weeks and three months.]

Sleep [Time Frame: Change from baseline to six weeks and three months.]

Pain interference [Time Frame: Change from baseline to six weeks and three months.]

Secondary ID(s)

SPIRE2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Health Informatics Society of Ireland

Irish Society of Chartered Physiotherapists