Chronic Pain, WidespreadNCT03150017
An Internet-Delivered Pain Management Programme for Spinal Cord Injury Pain
A study testing SPIRE in people with Chronic Pain, Widespread and Spinal Cord Injuries, run by Dearbhla Burke at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Widespread, Spinal Cord Injuries
- What is being tested?
- SPIRE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIreland
- Study dates
- 8 Mar 2017to 23 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Widespread, Spinal Cord Injuries
- Being tested
- SPIRE
- Medical subject headings
- Chronic Pain, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIREOther
Online pain management programme.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: SPIRE |
| Usual Care | No intervention | Continue to manage pain using usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of life as measured by the WHO QoL Bref
Measured: Change from baseline to six weeks and three months.
Secondary outcomes (6)
Sleep
Sleep quality using the Pittsburgh Sleep Quality Index
Measured: Change from baseline to six weeks and three months.
Mood
Mood measured using the Hospital Anxiety and Depression Scale
Measured: 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)
Measured: Change from baseline to six weeks and three months.
Pain interference
Pain interference measured using the brief pain inventory
Measured: Change from baseline to six weeks and three months.
Pain acceptance
Pain acceptance measured using the chronic pain acceptance questionnaire
Measured: 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
Measured: Change from baseline to six weeks and three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start8 Mar 2017
- Primary completion23 Aug 2017 (estimated)
- Study completion23 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain, WidespreadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dearbhla Burke
- Sponsor type
- University, hospital or other
- Collaborators
- Health Informatics Society of Ireland, Irish Society of Chartered Physiotherapists
- Responsible party
- Sponsor-investigator, Dearbhla Burke, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150017
- Sponsor's protocol ID
- SPIRE2017
- Status last verified
- May 2017
- First submitted
- 5 May 2017
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Internet-Delivered Cognitive Behavioural Therapy Pain Management Programme (PMP) on People With Spinal Cord Injuries: A Pilot Study
- ClinicalTrials.gov ID
- NCT03150017
- Acronym / sponsor ID
- SPIRE2017
- Conditions
- Chronic Pain, Widespread, Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dearbhla BurkeUniversity, hospital or other
- Collaborators
- Health Informatics Society of Ireland, Irish Society of Chartered Physiotherapists
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 23 Aug 2017 (estimated)
- Study completion
- 23 Aug 2017 (estimated)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online programme | Experimental | Other: SPIRESPIRE 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. |
| Usual Care | No intervention | –Continue to manage pain using usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPIREOnline pain management programme. | Other | Online programme |
Primary outcome
Quality of life
Time frame: Change from baseline to six weeks and three months.
Quality of life as measured by the WHO QoL Bref
6 secondary outcomes
Sleep
Time frame: Change from baseline to six weeks and three months.
Mood
Time frame: Change from baseline to six weeks and three months.
Pain
Time frame: Change from baseline to six weeks and three months.
Pain interference
Time frame: Change from baseline to six weeks and three months.
Pain acceptance
Time frame: Change from baseline to six weeks and three months.
Patients impression of change
Time frame: Change from baseline to six weeks and three months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPIRE in people with Chronic Pain, Widespread and Spinal Cord Injuries, run by Dearbhla Burke at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: Change from baseline to six weeks and three months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.