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.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Absenteeism* ; Cognitive Behavioral Therapy*/economics ; Disability Evaluation* ; Goals* ; Research Design* ; Sick Leave*/economics ; Surveys and Questionnaires*; Back Pain/*rehabilitation ; Chronic Pain/*rehabilitation; Adult ; Back Pain/diagnosis ; Back Pain/economics ; Back Pain/physiopathology ; Back Pain/psychology ; Catastrophization/psychology ; Chronic Pain/diagnosis ; Chronic Pain/economics ; Chronic Pain/physiopathology ; Chronic Pain/psychology ; Clinical Protocols ; Cost of Illness ; Cost-Benefit Analysis ; Depression/psychology ; Fatigue/psychology ; Fear ; Feasibility Studies ; Health Care Costs ; Humans ; Ireland ; Pain Measurement ; Return to Work ; Time Factors ; Treatment Outcome

Background: Psychologically 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 Design: Adult 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.
Discussion: This 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 Registration: Current Controlled Trials: ISRCTN61650533.

Pain. 1992 Aug;50(2):133-149. (PMID: 1408309)
Cochrane Database Syst Rev. 2012 Nov 14;11:CD007407. (PMID: 23152245)
J Manipulative Physiol Ther. 2003 May;26(4):213-9. (PMID: 12750654)
Eur J Pain. 2006 May;10(4):287-333. (PMID: 16095934)
Arthritis Rheum. 2008 May 15;59(5):632-41. (PMID: 18438893)
Clin J Pain. 2003 Mar-Apr;19(2):97-104. (PMID: 12616179)
Pain. 2000 Jan;84(1):95-103. (PMID: 10601677)
Phys Ther. 2011 May;91(5):804-19. (PMID: 21451098)
J Pain. 2012 Feb;13(2):139-45. (PMID: 22300900)
Eur J Pain. 2004 Jun;8(3):201-10. (PMID: 15109970)
Control Clin Trials. 1998 Dec;19(6):589-601. (PMID: 9875838)
Pain. 2011 May;152(5):1096-1103. (PMID: 21450402)
Ir J Med Sci. 2006 Apr-Jun;175(2):68-73. (PMID: 16872034)
Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. (PMID: 6222486)
J Occup Rehabil. 2005 Sep;15(3):377-92. (PMID: 16119228)
Pain. 2006 May;122(1-2):1-3. (PMID: 16530969)
Br J Gen Pract. 2007 Aug;57(541):655-61. (PMID: 17688762)
Eur J Pain. 2011 Apr;15(4):416-22. (PMID: 20884261)
Arthritis Rheum. 2006 Dec;54(12):3999-4010. (PMID: 17133530)
Acta Psychiatr Scand. 1983 Jun;67(6):361-70. (PMID: 6880820)
Fam Pract. 2011 Feb;28(1):12-21. (PMID: 20833704)
Pain. 2005 Dec 15;119(1-3):183-190. (PMID: 16297552)
Pain. 2009 Apr;142(3):202-208. (PMID: 19217717)
Lancet. 2011 Oct 29;378(9802):1560-71. (PMID: 21963002)
Fam Pract. 2005 Jun;22(3):323-7. (PMID: 15824056)
Phys Ther. 2006 Jan;86(1):8-18. (PMID: 16386058)
Pain. 1987 Aug;30(2):191-197. (PMID: 3670870)
Pain. 2005 Feb;113(3):310-315. (PMID: 15661438)
Spine (Phila Pa 1976). 2007 Jun 15;32(14):1474-81. (PMID: 17572614)
Clin J Pain. 2005 Jan-Feb;21(1):1-8. (PMID: 15599126)
Pain. 1993 Feb;52(2):157-168. (PMID: 8455963)

ISRCTN ISRCTN61650533

Date Created: 20130912 Date Completed: 20141104 Latest Revision: 20220409

20231215

PMC3847541

10.1186/1745-6215-14-290

24021094