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

Primary Purpose

Chronic Pain, Widespread, Spinal Cord Injuries

Status

Unknown status

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

SPIRE

About this trial

This is an interventional treatment trial for Chronic Pain, Widespread

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

School of Public Health Physiotherapy and Sports Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Online programme

Usual Care

Arm Description

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.

Continue to manage pain using usual care.

Outcomes

Primary Outcome Measures

Quality of life

Quality of life as measured by the WHO QoL Bref

Secondary Outcome Measures

Sleep

Sleep quality using the Pittsburgh Sleep Quality Index

Mood

Mood measured using the Hospital Anxiety and Depression Scale

Pain

Pain measured using the International Spinal Cord Injury Pain Basic Dataset (ISCIPDS:B) (Version 1)

Pain interference

Pain interference measured using the brief pain inventory

Pain acceptance

Pain acceptance measured using the chronic pain acceptance questionnaire

Patients impression of change

Patients impression of change as measured using the Patient's Global Impression of Change

Full Information

NCT ID

NCT03150017

First Posted

May 5, 2017

Last Updated

May 10, 2017

Sponsor

Dearbhla Burke

Collaborators

Health Informatics Society of Ireland, Irish Society of Chartered Physiotherapists

1. Study Identification

Unique Protocol Identification Number

NCT03150017

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 8, 2017 (Actual)

Primary Completion Date

August 23, 2017 (Anticipated)

Study Completion Date

August 23, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dearbhla Burke

Collaborators

Health Informatics Society of Ireland, Irish Society of Chartered Physiotherapists

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Widespread, Spinal Cord Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Online programme

Arm Type

Experimental

Arm Description

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Continue to manage pain using usual care.

Intervention Type

Other

Intervention Name(s)

SPIRE

Intervention Description

Online pain management programme.

Primary Outcome Measure Information:

Title

Quality of life

Description

Quality of life as measured by the WHO QoL Bref

Time Frame

Change from baseline to six weeks and three months.

Secondary Outcome Measure Information:

Title

Sleep

Description

Sleep quality using the Pittsburgh Sleep Quality Index

Time Frame

Change from baseline to six weeks and three months.

Title

Mood

Description

Mood measured using the Hospital Anxiety and Depression Scale

Time Frame

Change from baseline to six weeks and three months.

Title

Pain

Description

Pain measured using the International Spinal Cord Injury Pain Basic Dataset (ISCIPDS:B) (Version 1)

Time Frame

Change from baseline to six weeks and three months.

Title

Pain interference

Description

Pain interference measured using the brief pain inventory

Time Frame

Change from baseline to six weeks and three months.

Title

Pain acceptance

Description

Pain acceptance measured using the chronic pain acceptance questionnaire

Time Frame

Change from baseline to six weeks and three months.

Title

Patients impression of change

Description

Patients impression of change as measured using the Patient's Global Impression of Change

Time Frame

Change from baseline to six weeks and three months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

School of Public Health Physiotherapy and Sports Science

City

Dublin

Country

Ireland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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