Musculoskeletal PainSTEP-UPNCT01992770
A Stepped-care Model of Tailored Behavioural Medicine Pain Intervention in Primary Care
A study testing Hierarchical graded exposure, Graded activity and Physical exercises in people with Musculoskeletal Pain, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Hierarchical graded exposure, Graded activity and Physical exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- musculoskeletal pain from the low back, neck or with widespread locations
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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.
Read the 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
- 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).
- 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).
- To characterize patients who benefit/do not benefit from (1) a minimal intervention including advice, (2) TBM and physical exercise treatment respectively
- To identify potential moderators (e.g. pain duration, sex, outcome expectations) and mediators (e.g. catastrophising, fear of movement, self-efficacy) of treatment effects.
- 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- Hierarchical graded exposure, Graded activity, Physical exercises
- Keywords
- behavioural medicine, pain, physical therapy, physical exercise, primary care
- Medical subject headings
- Musculoskeletal Pain, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hierarchical graded exposureBehavioural
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.
Graded activityBehavioural
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.
Physical exercisesBehavioural
Participants will be scheduled for supervised, regular physical training twice a week during eight weeks 8
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Physical exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Secondary outcomes (6)
Health related quality of life
SF-36
Measured: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
General health perceptions
EQ5D
Measured: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Sick-absence and disability pension
patients self-reports of shorter sick-leave (sick-leave under 14 days), and sick-leave data collected from the Swedish Social Insurance Administration after permission from the Data Inspectorate
Measured: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Pain intensity
Numerical rating scale (0-10), maximum, minimum average pain during past two weeks
Measured: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Participants´rating of global improvement and satisfactions with treatment
The Patient Global Impression of Change Scale
Measured: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Physical activity
IPAQ, Daily physical activity log
Measured: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionJan 2017
Why it stopped: Organisational changes at primary care units.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Rheumatism Ass
- Responsible party
- Sponsor
- Investigators
- Pernilla Åsenlöf, Professor, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992770
- Sponsor's protocol ID
- 2012/448
- Acronym
- STEP-UP
- Status last verified
- Dec 2019
- First submitted
- 23 Sep 2013
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01992770
- Acronym / sponsor ID
- STEP-UP / 2012/448
- Conditions
- Musculoskeletal Pain
- Keywords
- behavioural medicine, pain, physical therapy, physical exercise, primary care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Organisational changes at primary care units.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Rheumatism Ass
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
- 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).
- To characterize patients who benefit/do not benefit from (1) a minimal intervention including advice, (2) TBM and physical exercise treatment respectively
- To identify potential moderators (e.g. pain duration, sex, outcome expectations) and mediators (e.g. catastrophising, fear of movement, self-efficacy) of treatment effects.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored behavioural medicine | Experimental | Behavioral: Hierarchical graded exposure, Behavioral: Graded activity, Behavioral: Physical exercisesAfter 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. |
| Control group | Active comparator | Behavioral: Physical exercisesParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- musculoskeletal pain from the low back, neck or with widespread locations
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hierarchical graded exposureIndividual 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. | Behavioural | Tailored behavioural medicine |
| Graded activityIndividual 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. | Behavioural | Tailored behavioural medicine |
| Physical exercisesParticipants will be scheduled for supervised, regular physical training twice a week during eight weeks 8 | Behavioural | Control group, Tailored behavioural medicine |
Primary outcome
Changes in pain-related disability including pain severity
Time frame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Pain Disability Index The Chronic Pain Grade The Patient Priority Goal Questionnaire (Patient-specific measure for the study of clinical significance and goal attainment)
6 secondary outcomes
Health related quality of life
Time frame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
General health perceptions
Time frame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Sick-absence and disability pension
Time frame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Pain intensity
Time frame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Participants´rating of global improvement and satisfactions with treatment
Time frame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Physical activity
Time frame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up
Results and safety
The study was stopped early (reason given: Organisational changes at primary care units.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernilla Åsenlöf, Professor principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hierarchical graded exposure, Graded activity and Physical exercises in people with Musculoskeletal Pain, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Organisational changes at primary care units.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain-related disability including pain severity (time frame: baseline, after 2 week, post-treatment, 12 months follow-up, 24 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.