Clinical trial NCT01992770: A Stepped-care Model of Tailored Behavioural Medicine Pain Intervention in Primary Care
Official title: STEP-UP - A Randomised Controlled Trial for the Study of a Stepped-care Model Including a Tailored Behavioural Medicine Pain Intervention in Primary Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: behavioural medicine
pain
physical therapy
physical exercise
primary care
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: The Swedish Rheumatism Ass
First posted: 2013-11-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: STEP-UP: An innovative stepped-care model for tailored behavioral medicine treatment in the management of musculoskeletal pain in primary care

Background:

Multimodal rehabilitation and tailored behavioral medicine treatments should be provided to patients suffering from persistent and activity limiting pain according to current state-of-science. There is also evidence that a simple and specific 'stay-active advice' can produce effects comparable to effects of comprehensive treatment packages. Nevertheless, there is a gap of knowledge regarding which individuals who benefit the most from which modalities of pain treatment, at what time point, and with the highest cost-effectiveness. Accordingly, we have set up an innovative stepped-care protocol for the management of musculoskeletal pain in primary care, which is evaluated in a randomized controlled trial. 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 HBC. In this application, the intervention is labelled tailored behavioural medicine intervention (TBM).

Main objectives

1. To compare the short- (post-treatment) and long-term effects (12 and 24 months follow-ups) of TBM and physical exercise treatment on everyday life activity, health related quality of life, pain severity, and sick leave (main analysis).
2. To study whether TBM tailored according to any of two pre-defined patient risk profiles: "the catastrophising/fear-avoidance profile" and "the moderate to high disability profile" are more effective compared to physical exercise treatment (sub- group analysis).
3. To characterize patients who benefit/do not benefit from (1) a minimal intervention including advice, (2) TBM and physical exercise treatment respectively
4. To identify potential moderators (e.g. pain duration, sex, outcome expectations) and mediators (e.g. catastrophising, fear of movement, self-efficacy) of treatment effects.
5. To study the cost-effectiveness within the experimental trial i.e. for the TBM versus the physical exercise treatment over the entire study period (up to 24-month follow- up).

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.

Eligibility criteria: Inclusion Criteria:

* musculoskeletal pain from the low back, neck or with widespread locations

Exclusion Criteria:

* patients scoring high on the Montgomery Åsberg Depression Rating Scale (MADRS; \> 35 or \> 4 on the suicidal risk item)
* patients suffering from other psychiatric or severe medical co-morbidity (e.g. cancer)
* patients presenting a history and physical symptoms indicating serious spinal pathology (red flags) implying further diagnostic examination or acute measures.
* patients not being able to read, write and discuss their everyday life situation in Swedish or accepting an interpreter are not included
* patients who have completed multimodal treatments due to the current pain condition during the past two years.

Primary outcomes:
measure: Changes in pain-related disability including pain severity
timeFrame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Secondary outcomes:
measure: Health related quality of life
timeFrame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
measure: General health perceptions
timeFrame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
measure: Sick-absence and disability pension
timeFrame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
measure: Pain intensity
timeFrame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
measure: Participants´rating of global improvement and satisfactions with treatment
timeFrame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
measure: Physical activity
timeFrame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Other outcomes:
measure: Sick-leave
timeFrame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
measure: Prognostic factors
timeFrame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
measure: Demographic and background factors
timeFrame: baseline
measure: Costs
timeFrame: 12 months follow-up, 24 months follow-up
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Pernilla Åsenlöf, Professor
role: PRINCIPAL_INVESTIGATOR
References: