Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Brian McGuire
ORCID ID
Contact details
Clinical Psychology Dept
School of Psychology
NUI Galway
2nd Floor
Woodquay Court
Galway
-
Ireland
+353 (0)91 493 266
brian.mcguire@nuigalway.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Reducing Long-Term Disability Related to Pain: A Single centre, randomised controlled trial evaluating the Pain Disability Prevention Program in the Irish health service
Acronym
PDP Ireland
Study hypothesis
1. Those receiving 'PDPP plus medical treatment as usual' will demonstrate reduced disability, improved quality of life and reduced pain catastrophising than those receiving medical treatment as usual only.
2. Those who received the PDP intervention will report higher rates of readiness to return to work compared to those receiving medical treatment as usual.
3. That the PDPP will demonstrate a positive cost-benefit outcome, where the costs of treatment will be less than the savings associated with better outcomes
Ethics approval
The National University of Ireland, Galway Research Ethics Committee (REC) approved on the 9th of November 2009
Study design
Single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information sheet available at http://www.nuigalway.ie/research/pdp/downloads/patient_info_leaflet.pdf
Condition
Chronic pain
Intervention
The intervention is a community based rehabilitation programme for patients with chronic pain who show elevated psycho-social risk factors for disability. Patients with pain for less than 12 months will be targeted. Patients will be randomised to either
1. Intervention group:
Patients will have 10 x 1-hour sessions with a clinical psychologist in their local area (as well as Medical Treatment as Usual). The psychologist will have completed specific Pain Pain Disability Prevention Programme training. The intervention (PDP) is a cognitive behaviourally based programme involving activity scheduling, cognitive restructuring, communication skills and problem solving.
2. Control group:
Medical Treatment as Usual.
The duration of the intervention will be 10 weeks. The total duration of follow up will be one year.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Pain Catastrophising, measured using the Pain Catastrophising Scale
2. Fear of movement measured using the Tampa Scale for kinesiophobia
3. Perceived Disability (Perceived Disability Scale)
4. Depression (Beck Depression Inventory)
5. Pain (McGill Pain Questionnaire) all
6. Healthcare costs will be measured using the Client Services Receipt Inventory, measuring healthcare utilisation for the 10 weeks prior to baseline, during the 10 week intervention and again after 12 months
Patients in both groups will be assessed pre-treatment, post-treatment (or after 10 weeks for the controls) and there will be a 1-year follow-up for both groups.
Secondary outcome measures
Readiness to return to work - with high unemployment, return to work may not be a feasible outcome measure. However we will examine changes in level of disability post intervention and readiness to return to work as a proxy for return to work.
Overall trial start date
01/01/2011
Overall trial end date
31/05/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or over
2. Patients referred by their GP with a current musculoskeletal injury and associated pain
The injury and pain must be of at least 1 month duration and not more than 12 months duration. Patients with a recurrence of pain associated with a pre-existing musculoskeletal injury may be included if the current pain represents a distinct recurrence. GPs must confirm the presence of the painful condition and approve participation in an activation programme.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140: 70 per condition
Participant exclusion criteria
1. Patients with significant cognitive impairment or psychiatric illness (based on the recorded judgement of the GP) that would render them incapable of understanding and participating in the project
2. Pain related to a malignancy
3. Insufficient English language ability to answer questions and/or participate in treatment
Recruitment start date
31/03/2011
Recruitment end date
31/03/2013
Locations
Countries of recruitment
Ireland
Trial participating centre
National University of Ireland Galway
Clinical Psychology Dept
Galway
-
Ireland
Sponsor information
Organisation
National University of Ireland, Galway (NUIG) (Ireland)
Sponsor details
School of Psychology
NUI Galway
2nd Floor
Woodquay Court
Galway
-
Ireland
+353 (0)91 493 266
brian.mcguire@nuigalway.ie
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Heath Research Board, Dublin (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24021094
Publication citations
-
Protocol
Raftery MN, Murphy AW, O'Shea E, Newell J, McGuire BE, Effectiveness of a cognitive behavioural therapy-based rehabilitation programme (Progressive Goal Attainment Program) for patients who are work-disabled due to back pain: study protocol for a multicentre randomised controlled trial., Trials, 2013, 14, 290, doi: 10.1186/1745-6215-14-290.