Abstract
BackgroundPsychologically informed rehabilitation programmes such as the Progressive Goal Attainment Program (PGAP) have the potential to address pain-related disability by targeting known psychological factors that inhibit rehabilitation progress. However, no randomised controlled trials of this intervention exist and it has not been evaluated in the Irish health service context. Our objective was to evaluate the clinical efficacy and cost-effectiveness of the PGAP in a multicentre randomised controlled trial with patients who are work-disabled due to back pain.Methods and designAdult patients (ages 18 years and older) with nonmalignant back pain who are work-disabled because of chronic pain and not involved in litigation in relation to their pain were invited to take part. Patients were those who show at least one elevated psychosocial risk factor (above the 50th percentile) on pain disability, fear-based activity avoidance, fatigue, depression or pain catastrophizing. Following screening, patients are randomised equally to the intervention or control condition within each of the seven trial locations. Patients allocated to the control condition receive usual medical care only. Patients allocated to the PGAP intervention condition attend a maximum of 10 weekly individual sessions of structured active rehabilitation in addition to usual care. Sessions are delivered by a clinical psychologist and focus on graded activity, goal-setting, pacing activity and cognitive-behavioural therapy techniques to address possible barriers to rehabilitation.The primary analysis will be based on the amount of change on the Roland Morris Disability Questionnaire posttreatment. We will also measure changes in work status, pain intensity, catastrophizing, depression, fear avoidance and fatigue. Outcome measures are collected at baseline, posttreatment and 12-month follow-up. Health-related resource use is also collected pre- and posttreatment and at 12-month follow-up to evaluate cost-effectiveness.DiscussionThis study will be the first randomized controlled trial of the PGAP in chronic pain patients and will provide important information about the clinical and cost effectiveness of the programme as well as its feasibility in the context of the Irish health service.Trial registrationCurrent Controlled Trials: ISRCTN61650533
Highlights
Informed rehabilitation programmes such as the Progressive Goal Attainment Program (PGAP) have the potential to address pain-related disability by targeting known psychological factors that inhibit rehabilitation progress
Research has consistently highlighted the importance of psychological factors in the development and maintenance of back pain disability [6]
We propose to conduct a qualitative study with those receiving PGAP and the primary referral sources to get feedback on the user-friendliness of the programme, since establishing the feasibility of the programme is a specific objective
Summary
This PGAP study is a pragmatic, multicentre randomised controlled trial of a cognitive behavioural therapy–based active rehabilitation programme for patients who are work-disabled due to back pain. A patient is deemed suitable to go forward to the treatment allocation stage of the trial based on the presence of elevated psychosocial risk factors This is defined as a score above the 50th percentile on any of the five risk factors targeted by the intervention: catastrophizing (Pain Catastrophizing Scale), fear of movement (Fear-Avoidance Beliefs Questionnaire), disability (Roland-Morris Disability Questionnaire), depression (Hospital Anxiety and Depression Scale) and fatigue (Fear and Fatigue Scale). Patients who are randomised to the control condition will not be precluded from enrolling in a psychological pain management programme for the duration of this trial If this happens, their data will be excluded from analysis. Qualitative analysis Following the randomised controlled trial, qualitative research will be undertaken to explore the perceptions, views and experiences of patients and clinicians who participated and delivered the PGAP. BMcG is Senior Lecturer in Clinical Psychology and Co-Director, Centre for Pain Research at NUI, Galway and Principal Investigator of the study
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