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

NCT01992770 | Terminated

• 1 other identifier: 2012/448
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Keywords

behavioural medicine; pain; physical therapy; physical exercise; primary care

Outcome Measures

Primary Outcomes (1)

• Changes in pain-related disability including pain severity

  Pain Disability Index The Chronic Pain Grade The Patient Priority Goal Questionnaire (Patient-specific measure for the study of clinical significance and goal attainment)

  baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up

Secondary Outcomes (6)

• Health related quality of life

  baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up

• General health perceptions

  baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up

• Sick-absence and disability pension

  baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up

• Pain intensity

  baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up

• Participants´rating of global improvement and satisfactions with treatment

  baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up

Other Outcomes (4)

• Sick-leave

  baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up

• Prognostic factors

  baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up

• Demographic and background factors

  baseline

Study Arms (2)

Tailored behavioural medicine

EXPERIMENTAL

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, depending on risk profile. 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.

Behavioral: Hierarchical graded exposure; Behavioral: Graded activity; Behavioral: Physical exercises

Control group

ACTIVE COMPARATOR

Participants will be scheduled for supervised, regular Physical exercises twice a week during eight weeks 8. Participants with a "moderate to high disability" risk profile will receive: Tailored graded activities training.

Behavioral: Physical exercises

Interventions

Hierarchical graded exposure BEHAVIORAL

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.

Tailored behavioural medicine

Graded activity BEHAVIORAL

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.

Tailored behavioural medicine

Physical exercises BEHAVIORAL

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

Control group; Tailored behavioural medicine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead
• The Swedish Rheumatism Ass: collaborator

Study Sites (1)

Uppsala University

Uppsala, Sweden

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pernilla Åsenlöf, Professor

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: November 25, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2017
• Last Updated: December 19, 2019

Record last verified: 2019-12

Locations

SE (1)