The effect of pain management group on chronic pain and pain related co-morbidities and symptoms. A stepped-wedge cluster randomized controlled trial. A study protocol

Abstract

Introduction: In primary care settings, pain-management group therapy is a tool potentially cost-effective but very much underused.

Methods: Our purpose here is to provide useful scientific information on the effect of pain-management group participation on chronic pain and pain-related co-morbidities and symptoms, as well as practical information for primary and occupational health services to initiate pain-management group activity.This study will be carried out at primary care Occupational Health Helsinki (Helsinki city employees' occupational health services), with the Finnish Institute of Occupational Health as the research partner.This is a stepped-wedge cluster randomized controlled trial among both male and female municipal employees aged 18 to 65, all of whom had visited an occupational doctor, nurse, psychologist, or physiotherapist because of any chronic pain unrelated to malignant disease. An additional inclusion criterion is work disability risk being elevated, based on a short screening questionnaire (modified Örebro questionnaire). Each participant and each interviewer will be blinded at randomization.Three groups, 10 subjects in each, begin directly after recruitment with 6 weekly 2-h meetings and a follow-up meeting 6 months later. Three waiting-list groups begin 4 months later. Subjects complete self-administered questionnaires before and after the sixth meetings, also 6 months later. Primary outcomes are pain intensity, current work ability, pain self-efficacy, fear-avoidance beliefs, chronic pain acceptance, depressive symptoms, sleep problems, sickness absence days, and number of occupational health care contacts from OH's medical records.

Results: We will publish our results in a peer-reviewed scientific journals.

Keywords: Chronic pain; Health services; Occupational health; Pain management; Self-efficacy.

Fig. 1

Study design of a stepped-wedge cluster randomized controlled trial. Shaded cells are intervention periods, and blank cells are control periods. This trial has six data-collection points. Surveys: Scr = screening, Bef1 = before intervention (1st time), Bef2 = before intervention (2nd time), Aft = immediately after intervention, Aft6m = 6 months after intervention, Aft12 m = 12 months after intervention, for only half of the clusters.

Fig. 2

Timetable for the intervention.