Condition category
Signs and Symptoms
Date applied
29/10/2010
Date assigned
04/03/2011
Last edited
19/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.nuigalway.ie/pdp

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 measures

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

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

http://www.nuigalway.ie/

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24021094

Publication citations

  1. 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.

Additional files

Editorial Notes