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

Not Applicable

• Conditions: Spinal Cord Injuries; Chronic Pain, Widespread

• Registration Number: NCT03150017
• Lead Sponsor: Dearbhla Burke

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.

Study Timeline

• Study Start: 2017-03-08
• Status Verified: 2017-05
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-10
• Last Update Submitted: 2017-05-10
• Study First Posted: 2017-05-11
• Last Update Posted: 2017-05-11
• Primary Completion: 2017-08-23
• Study Completion: 2017-08-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life	Change from baseline to six weeks and three months.	Quality of life as measured by the WHO QoL Bref

Secondary Outcome Measures

Name	Time	Method
Sleep	Change from baseline to six weeks and three months.	Sleep quality using the Pittsburgh Sleep Quality Index
Mood	Change from baseline to six weeks and three months.	Mood measured using the Hospital Anxiety and Depression Scale
Pain acceptance	Change from baseline to six weeks and three months.	Pain acceptance measured using the chronic pain acceptance questionnaire
Patients impression of change	Change from baseline to six weeks and three months.	Patients impression of change as measured using the Patient's Global Impression of Change
Pain	Change from baseline to six weeks and three months.	Pain measured using the International Spinal Cord Injury Pain Basic Dataset (ISCIPDS:B) (Version 1)
Pain interference	Change from baseline to six weeks and three months.	Pain interference measured using the brief pain inventory

Trial Locations

Locations (1)

School of Public Health Physiotherapy and Sports Science; 🇮🇪 Dublin, Ireland