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

Spinal Cord Injuries Clinical Trial

Official title:

The Impact of an Internet-Delivered Cognitive Behavioural Therapy Pain Management Programme (PMP) on People With Spinal Cord Injuries: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03150017
• Other study ID #: SPIRE2017
• Status: Active, not recruiting
• Phase: N/A
• First received: May 5, 2017
• Last updated: May 10, 2017
• Start date: March 8, 2017
• Est. completion date: August 23, 2017

Study information

• Verified date: May 2017
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: August 23, 2017
• Est. primary completion date: August 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain, Widespread
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• SPIRE
Online pain management programme.

Locations

Country	Name	City	State
Ireland	School of Public Health Physiotherapy and Sports Science	Dublin

Sponsors (3)

Lead Sponsor	Collaborator
Dearbhla Burke	Health Informatics Society of Ireland, Irish Society of Chartered Physiotherapists

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Quality of life as measured by the WHO QoL Bref	Change from baseline to six weeks and three months.
Secondary	Sleep	Sleep quality using the Pittsburgh Sleep Quality Index	Change from baseline to six weeks and three months.
Secondary	Mood	Mood measured using the Hospital Anxiety and Depression Scale	Change from baseline to six weeks and three months.
Secondary	Pain	Pain measured using the International Spinal Cord Injury Pain Basic Dataset (ISCIPDS:B) (Version 1)	Change from baseline to six weeks and three months.
Secondary	Pain interference	Pain interference measured using the brief pain inventory	Change from baseline to six weeks and three months.
Secondary	Pain acceptance	Pain acceptance measured using the chronic pain acceptance questionnaire	Change from baseline to six weeks and three months.
Secondary	Patients impression of change	Patients impression of change as measured using the Patient's Global Impression of Change	Change from baseline to six weeks and three months.