Reducing Long-Term Disability Related to Pain: Evaluation of the Pain Disability Prevention Program in the Irish health service

ISRCTN	ISRCTN61650533
DOI	https://doi.org/10.1186/ISRCTN61650533
Secondary identifying numbers	N/A

Submission date: 29/10/2010
Registration date: 04/03/2011
Last edited: 19/01/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Brian McGuire
Scientific

Clinical Psychology Dept
School of Psychology
NUI Galway
2nd Floor
Woodquay Court
Galway
-
Ireland

Phone	+353 (0)91 493 266
Email	brian.mcguire@nuigalway.ie

Study information

Study design	Single centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information sheet available at http://www.nuigalway.ie/research/pdp/downloads/patient_info_leaflet.pdf
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
Study acronym	PDP Ireland
Study objectives	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(s)	The National University of Ireland, Galway Research Ethics Committee (REC) approved on the 9th of November 2009
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2011
Completion date	31/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	140: 70 per condition
Key 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.
Key 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
Date of first enrolment	31/03/2011
Date of final enrolment	31/03/2013

Locations

Countries of recruitment

Ireland

Study participating centre

National University of Ireland Galway

Clinical Psychology Dept
Galway
-
Ireland

Sponsor information

National University of Ireland, Galway (NUIG) (Ireland)
University/education

School of Psychology
NUI Galway
2nd Floor
Woodquay Court
Galway
-
Ireland

Phone	+353 (0)91 493 266
Email	brian.mcguire@nuigalway.ie
Website	http://www.nuigalway.ie/
"ROR"	https://ror.org/03bea9k73

Funders

Funder type

Government

Heath Research Board, Dublin (Ireland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	11/09/2013		Yes	No