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

NCT ID: NCT03150017

Last Updated: 2017-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2017-08-23

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.

Conditions

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Chronic Pain, Widespread Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SPIRE

Intervention Type OTHER

Online pain management programme.

Usual Care

Continue to manage pain using usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SPIRE

Online pain management programme.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Informatics Society of Ireland

UNKNOWN

Sponsor Role collaborator

Irish Society of Chartered Physiotherapists

UNKNOWN

Sponsor Role collaborator

Dearbhla Burke

OTHER

Sponsor Role lead

Responsible Party

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Dearbhla Burke

PhD Candidate

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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School of Public Health Physiotherapy and Sports Science

Dublin, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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SPIRE2017

Identifier Type: -

Identifier Source: org_study_id

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