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

NCT03150017 | Unknown

• 1 other identifier: SPIRE2017
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain, Widespread; Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Quality of life

  Quality of life as measured by the WHO QoL Bref

  Change from baseline to six weeks and three months.

Secondary Outcomes (6)

• Sleep

  Change from baseline to six weeks and three months.

• Mood

  Change from baseline to six weeks and three months.

• Pain

  Change from baseline to six weeks and three months.

• Pain interference

  Change from baseline to six weeks and three months.

• Pain acceptance

  Change from baseline to six weeks and three months.

Study Arms (2)

Online programme

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Continue to manage pain using usual care.

Interventions

SPIRE OTHER

Online pain management programme.

Online programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dearbhla Burke: lead
• Health Informatics Society of Ireland: collaborator
• Irish Society of Chartered Physiotherapists: collaborator

Study Sites (1)

School of Public Health Physiotherapy and Sports Science

Dublin, Ireland

Location

MeSH Terms

Conditions

Chronic Pain; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 11, 2017
• Study Start: March 8, 2017
• Primary Completion: August 23, 2017
• Study Completion: August 23, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)