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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain, Widespread, Spinal Cord Injuries

Intervention / Treatment
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* Other: SPIRE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online programme<br>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<br>* Online pain management programme.<br>|
| No Intervention: Usual Care<br>Continue to manage pain using usual care. | |

What is the study measuring?
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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. |