A Stepped-care Model of Tailored Behavioural Medicine Pain Intervention in Primary Care

Summary

Background:

This study is based on an innovative stepped-care protocol for the management of musculoskeletal pain in primary care, which is evaluated in a RCT. The intervention have two core features: it is theory-driven and include systematic tailoring of treatment content. The tailoring is based on a combination of empirically supported behavioural and medical determinants of pain-related disability and patients' individual perceptions on personal goals, facilitators and barriers for health behavior change. In this application, the intervention is labelled tailored behavioural medicine intervention (TBM).

Objectives:

The aim is to compare effects and cost-effectiveness of a stepped care model including advice and tailored behavioral medicine pain treatment (experimental condition) with a stepped care model including advice and physical exercises (comparison condition) for patients with low back and neck pain and/or widespread pain including fibromyalgia in primary care. A further aim is to characterize patients who benefit/do not benefit from the respective steps i.e. treatments varying in dose and content.

Methods:

A stratified randomized stepped care design is applied. Stratification is based on primary care center and patient risk profile. A consecutive selection is performed at primary care centers in southern, central and northern Sweden. According to power analysis, 364 participants should be recruited to allow for sub-group analyses. After having received a minimal intervention (step 1) comprising 'stay-active advice', participants scoring \>90 on the Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) are randomly allocated to an eight-week treatment in step 2. The experimental condition includes supervised physical exercises integrated with either (a) graded activity, or (b) hierarchical graded exposure depending on risk profile, i.e. absence or presence of pain catastrophizing and fear-avoidance beliefs. The comparison condition includes supervised physical exercises irrespective of risk profile. Primary outcome is pain-related disability complemented with a comprehensive set of secondary outcomes adhering to the IMMPACT recommendations. Assessments will be made by personnel blinded for treatment condition at baseline, after step 1 and 2 respectively, and at 12- and 24-month follow-ups.

Conditions

• Musculoskeletal Pain

Interventions

BEHAVIORAL

Hierarchical graded exposure

Individual Behavioural goal identification, depending on risk profile (1a). "Catastrophising and/or fear-avoidance" (2); hierarchical graded exposure, organized with individual coaching in connection to the physical training sessions, based on activities that each participant fear and/or avoid.

BEHAVIORAL

Graded activity

Individual Behavioural goal identification, depending on risk profile (1b) "Graded activity";(2) self-monitoring of everyday life activities (3) functional behavioural analyses to describe, predict, and verify factors controlling patient's current and future activity performance (4) training of motor skills, cognitive skills, and strategies to organise everyday life including social support. (5) gradual application of acquired skills in everyday life situations as formulated by Specific, Measureable, Activity-related, Realistic, and Time- specified (SMART) goal setting (6) generalisation of skills to additional activities and challenging situations, and (7) strategies for maintenance and relapse prevention.

BEHAVIORAL

Physical exercises

Participants will be scheduled for supervised, regular physical training twice a week during eight weeks 8

Sponsors & Collaborators

• The Swedish Rheumatism Ass

  collaborator OTHER

• Uppsala University

  lead OTHER

Principal Investigators

• Pernilla Åsenlöf, Professor · Uppsala University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2015-12-31

Completion

2017-01-31

Countries

• Sweden

Study Locations