Chronic PainNCT03118453
Implementation of a Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain
A study testing Active implementation clinics and Passive implementation clinics in people with Chronic Pain and Musculoskeletal Pain, run by Mälardalen University at 3 sites in Sweden.
Trial summary
Implementation of a behavioral medicine (BM) approach in physical therapy (PT) for patients with persistent musculoskeletal pain is in accordance with the state of science. Translation of research into clinical PT practice is challenging and may demand active implementation strategies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain
- What is being tested?
- Active implementation clinics and Passive implementation clinics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 3 sitesSweden
- Study dates
- Nov 2016to Nov 2022
- 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
- Patients who presents for physical therapy in primary care.
- 18 - 65 years of age
- musculoskeletal pain for 4 weeks or more
- ability to speak and understand spoken and written Swedish
Who cannot join
- systemic disease
- malignity
- serious spinal pathology
- osteoarthritis waiting for surgery
- diagnosed depression
- neurological disease or injury that severely affect activity capacity
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Region Gävleborg
Gävle
Landstinget Sörmland
Nyköping, SE-61188
Region Västmanland
Västerås, SE-72189
About this study
Official title: A Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain - Evaluation of the Implementation Process and Outcome
Implementation of a behavioral medicine (BM) approach in physical therapy (PT) for patients with persistent musculoskeletal pain is in accordance with the state of science. Translation of research into clinical PT practice is challenging and may demand active implementation strategies.
The aim is to evaluate the implementation of a behavioural medicine approach for patients with persistent musculoskeletal pain concerning sustainable health benefits and sick-leave, as well as the cost-effectiveness of the implemented treatment.
Read more
Treatment outcomes for patients from two groups of physical therapists in primary care will be compared. In one group active implementation strategies have been employed, and in the other (control) passive implementation strategies during a 6-months intervention period. Patients are recruited during one-year after the implementation period.
The short and long-term effects of the implementation of the BM approach in PT treatment on patients' sick-leave, activity and participation, and health related quality of life will be compared to the patients from control condition clinics. The cost-effect and cost-benefit of an implementation of a behavioral medicine approach in physical therapy is evaluated from the perspective of the health care organization and society.
Read the detailed description
The aim is to investigate the short and long-term effects for the implementation of a behavioral medicine approach in physical therapy on patients' sick-leave, activity and participation, and health related quality of life, compared to the control condition. Further the aim is to evaluate the cost-effect and cost-benefit of an active implementation of a behavioural medicine approach in physical therapy, compared to the passive implementation in the control condition.
In total 109 primary care patients with musculoskeletal pain ≥ 4 weeks are included consecutively in the active implementation and passive implementation (control) clinics. The sample size was based on a priori power analysis on differences in primary outcome between conditions and expected attrition. Patients from both conditions are included during the first year after the implementation period.
Data collection has been at onset and end of patients' treatment period, and will be at 6, 12, and 18 months post treatment (in both implementation and control clinics).
Recommended core outcomes regarding body structure, activity and participation are used. Primary outcomes: Participation in work life defined as days of sick-leave and participation in everyday life. Secondary outcomes will be patients' ratings of global treatment effects and pain intensity. Process measures: prognostic psychosocial factors possible to address in physical therapy such as functional self-efficacy, fear of movement and patient expectations on treatment effects. Depression, seen as a confounder, will be controlled for. Calculation of costs will include avoidable cost of the implementation, sunk costs will be ignored. Direct health care costs, i.e. use of health care services will be identified, measured and priced to assess costs from a societal perspective. Indirect costs, i.e. production loss due to sick leave and health care visits will be estimated. Cost-benefit will be calculated from the perspective of the society. Economic benefits will be measured as the net value of production gained for society, with an appropriate discount rate. Costs for society will be calculated on direct health care costs.
Data analyses: Regression models are used to compare patient outcomes between implementation and control clinics and performed per protocol and on an intention-to-treat-basis. Total costs, i.e. direct health care costs, direct and indirect non-health care costs and incremental costs, will be compared between conditions. A ratio between difference in outcome scores and costs between baseline and 6, 12, and 18 months post treatment will be. Incremental costs will be calculated per cost-benefit ratio associated with treatments in the two conditions. Bootstrapping is used for confidence intervals for cost-effectiveness and cost-benefit ratios.
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Being tested
- Active implementation clinics, Passive implementation clinics
- Keywords
- Musculoskeletal pain/*therapy, Behavioral medicine, Physical therapy, Cost-benefit analyses, Treatment outcome, Adults
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active implementation clinicsBehavioural
Physical therapy treatment as the physical therapist chooses
Passive implementation clinicsBehavioural
Physical therapy treatment as the physical therapist chooses
| Study group | Role | What they receive |
|---|---|---|
| Active implementation clinics | Experimental | Patients recruited by physical therapists who underwent an implementation period with active implementations strategies, such as supervision, web lectures, peer learning in groups consisting of colleagues. A behavioral medicine approach in physical therapy for patients with musculoskeletal pain was encouraged with these active implementation strategies. Receives: Behavioral: Active implementation clinics |
| Passive implementation clinics | Active comparator | Patients recruited by physical therapists who underwent an implementation period with passive implementations strategies, such as written material and a short web lecture. A behavioral medicine approach in physical therapy for patients with musculoskeletal pain was encouraged with these passive implementation strategies Receives: Behavioral: Passive implementation clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in days of sick-leave
Self-reports and sick-leave data from the Swedish Social Insurance Administration
Measured: through study completion, an average of 1 year
Change in pain-related disability using Pain Disability Index
Pain Disability Index: Measure of disruptions in seven dimensions of everyday life. Self-reports on a11-graded numerical rating scale
Measured: through study completion, an average of 1 year
Change in health related quality of life using EQ-5D
EuroQol, Quality of life scale in 5 dimensions (EQ-5D) which provides a simple descriptive profile and a single index value for health status.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Change in the patients' perceptions of global treatment effect Change in perceived global treatment effect using the Patient Global Impression of Change Scale
Patients Global Impression of Change (PGIC) scale which provides the patient's belief about the treatment effect rated on a 7-graded scale
Measured: through study completion, an average of 1 year
Change in self-efficacy for daily activities using the Self-efficacy Scale
The Self-efficacy Scale: ratings of self-efficacy for 20 common activities in daily life
Measured: through study completion, an average of 1 year
Change in catastrophizing thoughts about pain using the Catastrophizing subscale of the Coping Strategies Questionnaire
The Catastrophizing subscale of the Coping Strategies Questionnaire: ratings of pain-related catastrophizing thoughts
Measured: through study completion, an average of 1 year
Change in fear of movement/(re)injury using the Tampa Scale of Kinesiophobia
The Tampa Scale of Kinesiophobia: ratings of fear and avoidance of movement
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study startNov 2016
- Primary completionSep 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mälardalen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Söderlund, professor, Principal investigator, Mälardalen University, Box 883, SE-721 23 Västerås, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118453
- Sponsor's protocol ID
- 140369
- Status last verified
- Nov 2019
- First submitted
- 20 Mar 2017
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data (IPD) because the participants have been assured of confidentiality and that only the researchers in the Project will have access to IPD
Publications
Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011 Oct 29;378(9802):1560-71. doi: 10.1016/S0140-6736(11)60937-9. Epub 2011 Sep 28.
PubMed 21963002Soderlund A, Lindberg P. Cognitive behavioural components in physiotherapy management of chronic whiplash associated disorders (WAD)--a randomised group study. G Ital Med Lav Ergon. 2007 Jan-Mar;29(1 Suppl A):A5-11.
PubMed 17650736Denison E, Asenlof P, Sandborgh M, Lindberg P. Musculoskeletal pain in primary health care: subgroups based on pain intensity, disability, self-efficacy, and fear-avoidance variables. J Pain. 2007 Jan;8(1):67-74. doi: 10.1016/j.jpain.2006.06.007. Epub 2006 Sep 1.
PubMed 16950657Asenlof P, Denison E, Lindberg P. Individually tailored treatment targeting activity, motor behavior, and cognition reduces pain-related disability: a randomized controlled trial in patients with musculoskeletal pain. J Pain. 2005 Sep;6(9):588-603. doi: 10.1016/j.jpain.2005.03.008.
PubMed 16139778Sandborgh M, Åsenlöf P, Lindberg P, Denison, E. Implementing behavioural medicine in physiotherapy treatment. Part II: Adherence to treatment protocol. Advances in Physiotherapy 12: 13-23, 2010 doi: 10.3109/14038190903480672
Phillips CJ. Economic burden of chronic pain. Expert Rev Pharmacoecon Outcomes Res. 2006 Oct;6(5):591-601. doi: 10.1586/14737167.6.5.591.
PubMed 20528505Mantyselka PT, Kumpusalo EA, Ahonen RS, Takala JK. Direct and indirect costs of managing patients with musculoskeletal pain-challenge for health care. Eur J Pain. 2002;6(2):141-8. doi: 10.1053/eujp.2001.0311.
PubMed 11900474Lamb SE, Lall R, Hansen Z, Castelnuovo E, Withers EJ, Nichols V, Griffiths F, Potter R, Szczepura A, Underwood M; BeST trial group. A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial. Health Technol Assess. 2010 Aug;14(41):1-253, iii-iv. doi: 10.3310/hta14410.
PubMed 20807469Wiltsey Stirman S, Kimberly J, Cook N, Calloway A, Castro F, Charns M. The sustainability of new programs and innovations: a review of the empirical literature and recommendations for future research. Implement Sci. 2012 Mar 14;7:17. doi: 10.1186/1748-5908-7-17.
PubMed 22417162Hahne AJ, Ford JJ, Richards MC, Surkitt LD, Chan AYP, Slater SL, Taylor NF. Who Benefits Most From Individualized Physiotherapy or Advice for Low Back Disorders? A Preplanned Effect Modifier Analysis of a Randomized Controlled Trial. Spine (Phila Pa 1976). 2017 Nov 1;42(21):E1215-E1224. doi: 10.1097/BRS.0000000000002148.
PubMed 28263227Fritz J, Almqvist L, Soderlund A, Wallin L, Sandborgh M. Patients' health outcomes after an implementation intervention targeting the physiotherapists' clinical behaviour. Arch Physiother. 2021 Oct 9;11(1):22. doi: 10.1186/s40945-021-00116-z.
PubMed 34625120
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain - Evaluation of the Implementation Process and Outcome
- ClinicalTrials.gov ID
- NCT03118453
- Acronym / sponsor ID
- 140369
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Keywords
- Musculoskeletal pain/*therapy, Behavioral medicine, Physical therapy, Cost-benefit analyses, Treatment outcome, Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Mälardalen UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 18 Apr 2017 (actual)
- 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.
Implementation of a behavioral medicine (BM) approach in physical therapy (PT) for patients with persistent musculoskeletal pain is in accordance with the state of science. Translation of research into clinical PT practice is challenging and may demand active implementation strategies.
The aim is to evaluate the implementation of a behavioural medicine approach for patients with persistent musculoskeletal pain concerning sustainable health benefits and sick-leave, as well as the cost-effectiveness of the implemented treatment.
Treatment outcomes for patients from two groups of physical therapists in primary care will be compared. In one group active implementation strategies have been employed, and in the other (control) passive implementation strategies during a 6-months intervention period. Patients are recruited during one-year after the implementation period.
The short and long-term effects of the implementation of the BM approach in PT treatment on patients' sick-leave, activity and participation, and health related quality of life will be compared to the patients from control condition clinics. The cost-effect and cost-benefit of an implementation of a behavioral medicine approach in physical therapy is evaluated from the perspective of the health care organization and society.
Detailed description
The aim is to investigate the short and long-term effects for the implementation of a behavioral medicine approach in physical therapy on patients' sick-leave, activity and participation, and health related quality of life, compared to the control condition. Further the aim is to evaluate the cost-effect and cost-benefit of an active implementation of a behavioural medicine approach in physical therapy, compared to the passive implementation in the control condition.
In total 109 primary care patients with musculoskeletal pain ≥ 4 weeks are included consecutively in the active implementation and passive implementation (control) clinics. The sample size was based on a priori power analysis on differences in primary outcome between conditions and expected attrition. Patients from both conditions are included during the first year after the implementation period.
Data collection has been at onset and end of patients' treatment period, and will be at 6, 12, and 18 months post treatment (in both implementation and control clinics).
Recommended core outcomes regarding body structure, activity and participation are used. Primary outcomes: Participation in work life defined as days of sick-leave and participation in everyday life. Secondary outcomes will be patients' ratings of global treatment effects and pain intensity. Process measures: prognostic psychosocial factors possible to address in physical therapy such as functional self-efficacy, fear of movement and patient expectations on treatment effects. Depression, seen as a confounder, will be controlled for. Calculation of costs will include avoidable cost of the implementation, sunk costs will be ignored. Direct health care costs, i.e. use of health care services will be identified, measured and priced to assess costs from a societal perspective. Indirect costs, i.e. production loss due to sick leave and health care visits will be estimated. Cost-benefit will be calculated from the perspective of the society. Economic benefits will be measured as the net value of production gained for society, with an appropriate discount rate. Costs for society will be calculated on direct health care costs.
Data analyses: Regression models are used to compare patient outcomes between implementation and control clinics and performed per protocol and on an intention-to-treat-basis. Total costs, i.e. direct health care costs, direct and indirect non-health care costs and incremental costs, will be compared between conditions. A ratio between difference in outcome scores and costs between baseline and 6, 12, and 18 months post treatment will be. Incremental costs will be calculated per cost-benefit ratio associated with treatments in the two conditions. Bootstrapping is used for confidence intervals for cost-effectiveness and cost-benefit ratios.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active implementation clinics | Experimental | Behavioral: Active implementation clinicsPatients recruited by physical therapists who underwent an implementation period with active implementations strategies, such as supervision, web lectures, peer learning in groups consisting of colleagues. A behavioral medicine approach in physical therapy for patients with musculoskeletal pain was encouraged with these active implementation strategies. |
| Passive implementation clinics | Active comparator | Behavioral: Passive implementation clinicsPatients recruited by physical therapists who underwent an implementation period with passive implementations strategies, such as written material and a short web lecture. A behavioral medicine approach in physical therapy for patients with musculoskeletal pain was encouraged with these passive implementation strategies |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who presents for physical therapy in primary care.
- 18 - 65 years of age
- musculoskeletal pain for 4 weeks or more
- ability to speak and understand spoken and written Swedish
Key exclusion criteria (6 listed)
- systemic disease
- malignity
- serious spinal pathology
- osteoarthritis waiting for surgery
- diagnosed depression
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 |
|---|---|---|
| Active implementation clinicsPhysical therapy treatment as the physical therapist chooses | Behavioural | Active implementation clinics |
| Passive implementation clinicsPhysical therapy treatment as the physical therapist chooses | Behavioural | Passive implementation clinics |
Primary outcome
Change in days of sick-leave
Time frame: through study completion, an average of 1 year
Self-reports and sick-leave data from the Swedish Social Insurance Administration
Change in pain-related disability using Pain Disability Index
Time frame: through study completion, an average of 1 year
Pain Disability Index: Measure of disruptions in seven dimensions of everyday life. Self-reports on a11-graded numerical rating scale
Change in health related quality of life using EQ-5D
Time frame: through study completion, an average of 1 year
EuroQol, Quality of life scale in 5 dimensions (EQ-5D) which provides a simple descriptive profile and a single index value for health status.
4 secondary outcomes
Change in the patients' perceptions of global treatment effect Change in perceived global treatment effect using the Patient Global Impression of Change Scale
Time frame: through study completion, an average of 1 year
Change in self-efficacy for daily activities using the Self-efficacy Scale
Time frame: through study completion, an average of 1 year
Change in catastrophizing thoughts about pain using the Catastrophizing subscale of the Coping Strategies Questionnaire
Time frame: through study completion, an average of 1 year
Change in fear of movement/(re)injury using the Tampa Scale of Kinesiophobia
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Background: PubMed 21963002Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011 Oct 29;378(9802):1560-71. doi: 10.1016/S0140-6736(11)60937-9. Epub 2011 Sep 28.
- Background: PubMed 17650736Soderlund A, Lindberg P. Cognitive behavioural components in physiotherapy management of chronic whiplash associated disorders (WAD)--a randomised group study. G Ital Med Lav Ergon. 2007 Jan-Mar;29(1 Suppl A):A5-11.
- Background: PubMed 16950657Denison E, Asenlof P, Sandborgh M, Lindberg P. Musculoskeletal pain in primary health care: subgroups based on pain intensity, disability, self-efficacy, and fear-avoidance variables. J Pain. 2007 Jan;8(1):67-74. doi: 10.1016/j.jpain.2006.06.007. Epub 2006 Sep 1.
- Background: PubMed 16139778Asenlof P, Denison E, Lindberg P. Individually tailored treatment targeting activity, motor behavior, and cognition reduces pain-related disability: a randomized controlled trial in patients with musculoskeletal pain. J Pain. 2005 Sep;6(9):588-603. doi: 10.1016/j.jpain.2005.03.008.
- BackgroundSandborgh M, Åsenlöf P, Lindberg P, Denison, E. Implementing behavioural medicine in physiotherapy treatment. Part II: Adherence to treatment protocol. Advances in Physiotherapy 12: 13-23, 2010 doi: 10.3109/14038190903480672
- Background: PubMed 20528505Phillips CJ. Economic burden of chronic pain. Expert Rev Pharmacoecon Outcomes Res. 2006 Oct;6(5):591-601. doi: 10.1586/14737167.6.5.591.
- Background: PubMed 11900474Mantyselka PT, Kumpusalo EA, Ahonen RS, Takala JK. Direct and indirect costs of managing patients with musculoskeletal pain-challenge for health care. Eur J Pain. 2002;6(2):141-8. doi: 10.1053/eujp.2001.0311.
- Background: PubMed 20807469Lamb SE, Lall R, Hansen Z, Castelnuovo E, Withers EJ, Nichols V, Griffiths F, Potter R, Szczepura A, Underwood M; BeST trial group. A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial. Health Technol Assess. 2010 Aug;14(41):1-253, iii-iv. doi: 10.3310/hta14410.
- Background: PubMed 22417162Wiltsey Stirman S, Kimberly J, Cook N, Calloway A, Castro F, Charns M. The sustainability of new programs and innovations: a review of the empirical literature and recommendations for future research. Implement Sci. 2012 Mar 14;7:17. doi: 10.1186/1748-5908-7-17.
- Background: PubMed 28263227Hahne AJ, Ford JJ, Richards MC, Surkitt LD, Chan AYP, Slater SL, Taylor NF. Who Benefits Most From Individualized Physiotherapy or Advice for Low Back Disorders? A Preplanned Effect Modifier Analysis of a Randomized Controlled Trial. Spine (Phila Pa 1976). 2017 Nov 1;42(21):E1215-E1224. doi: 10.1097/BRS.0000000000002148.
- Derived from this study: PubMed 34625120Fritz J, Almqvist L, Soderlund A, Wallin L, Sandborgh M. Patients' health outcomes after an implementation intervention targeting the physiotherapists' clinical behaviour. Arch Physiother. 2021 Oct 9;11(1):22. doi: 10.1186/s40945-021-00116-z.
- Individual participant dataSharing planned: No. No plan to share individual participant data (IPD) because the participants have been assured of confidentiality and that only the researchers in the Project will have access to IPD
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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.
Anne Söderlund, professor principal investigator
Mälardalen University, Box 883, SE-721 23 Västerås, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active implementation clinics and Passive implementation clinics in people with Chronic Pain and Musculoskeletal Pain, run by Mälardalen University at 3 sites 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Change in days of sick-leave (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03118453, which also lists 11 linked publications.
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 18 Nov 2019.