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

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

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injuries; Chronic Pain, Widespread
• Intervention / Treatment: Other: SPIRE

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • School of Public Health Physiotherapy and Sports Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online programme; SPIRE The programme consists of six modules over six weeks and is based on cognitive behavioural principles. It comprises psychology sessions using cognitive techniques to identify unhelpful and unrealistic thoughts and beliefs related to pain and to challenge and change them and weekly relaxation audios and a home exercise session. Goal setting by participants is used encouraged throughout the programme to aid the implementation of learned CBT techniques into daily life. Educational sessions are delivered across a range of topics including mechanisms of pain after SCI, explanations of the pain gate control theory and how CBT strategies employed can impact on the perception of pain, discussion of medication use, stress management and pacing strategies for activities of daily living.	Other: SPIRE; Online pain management programme.
No Intervention: Usual Care; Continue to manage pain using usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Quality of life as measured by the WHO QoL Bref	Change from baseline to six weeks and three months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep	Sleep quality using the Pittsburgh Sleep Quality Index	Change from baseline to six weeks and three months.
Mood	Mood measured using the Hospital Anxiety and Depression Scale	Change from baseline to six weeks and three months.
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.
Pain interference	Pain interference measured using the brief pain inventory	Change from baseline to six weeks and three months.
Pain acceptance	Pain acceptance measured using the chronic pain acceptance questionnaire	Change from baseline to six weeks and three months.
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.

Collaborators and Investigators

• Sponsor: Dearbhla Burke
• Collaborators: Health Informatics Society of Ireland; Irish Society of Chartered Physiotherapists

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Anticipated): August 23, 2017
• Study Completion (Anticipated): August 23, 2017

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Chronic Pain; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: SPIRE2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No