PainNCT00902642
What is the Effect of a Course for Treatment Providers on Their Patient Outcome
A study testing an eight day university training course designed to integrating psychosocial factors in clinical practice on a patient level in people with Pain, run by Örebro County Council at 1 site in Sweden.
Trial summary
The goal is to acquire more in-depth knowledge on physical therapists' attitudes towards and beliefs about psychosocial factors in back pain, how physical therapists integrate psychosocial factors into their clinical practice and the effects of a training program for physical therapists in psychosocial factors on… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- an eight day university training course designed to integrating psychosocial factors in clinical practice on a patient level
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2004to Aug 2006
- 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,
- Age between 18 and 65
Who cannot join
- Sick leave for more than 3 months during the past year as a result of present the musculoskeletal pain problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Training in Psychosocial Methods for Treatment Providers Improve Outcome for Pain Patients at Risk of Long-Term Disability? A Randomised Controlled Trail of a Course for Physical Therapists
The goal is to acquire more in-depth knowledge on physical therapists' attitudes towards and beliefs about psychosocial factors in back pain, how physical therapists integrate psychosocial factors into their clinical practice and the effects of a training program for physical therapists in psychosocial factors on clinical practice and thereby on patient outcome in terms of disability, pain, catastrophizing, and treatment satisfaction.
Read the detailed description
Neck and back pain continue to be extremely common, with a high prevalence and wide socio-economic consequences all over the industrialized world. Through the years a growing interest has risen for other factors than the pure biomedical or biomechanical. This has led to a new clinical model for the treatment of back pain; the biopsychosocial model of illness. Treatment based on the biopsychosocial model not only must address the biological basis of symptoms, but must incorporate the full range of social and psychological factors that have been shown to affect pain, distress and disability.
Since there is today strong evidence indicating that psychosocial factors have a greater impact on disability then biomechanical or biomedical factors and strong evidence that psychosocial factors are strongly linked to the transition from acute to chronic pain, concept of psychosocial risk factors has been developed. Although the concept of psychosocial risk factors still is relatively new, there seems to be an international consensus about the importance of psychosocial risk factors for the prevention of the development of chronic pain but there appears to be considerable uncertainty about the clinical application.
Health care providers' (HCPs') attitudes and beliefs appear to influence the information they provide to patients. This may subsequently result in different patient outcome depending on the HCPs' attitudes and beliefs. Physical therapists attitudes and beliefs are relatively unexplored but seem to have an effect on patients' attitudes and beliefs, which can affect patient outcome in terms of sick leave, health care use and function.
HCP attitudes and beliefs towards psychosocial factors are relatively unexplored. Yet, it seems physical therapists do not necessarily accept new evidence-based information and may have difficulties in applying evidence-based information in their clinical practice. Implementation and dissemination of evidence-based psychosocial factors requires favourable attitudes, knowledge and skills to ensure a behavioural change on behave of the physical therapists.
- Conditions
- Pain
- Being tested
- an eight day university training course designed to integrating psychosocial factors in clinical practice on a patient level
- Keywords
- Physical therapy,, musculoskeletal pain,, psychosocial factors,, dissimilation,, evidence based,, education
- Medical subject headings
- Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an eight day university training course designed to integrating psychosocial factors in clinical practice on a patient levelBehavioural
an eight day university training course on psychosocial factors for physical therapists
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| Course on psychosocial factors | Active comparator | an eight day university training course for physical therapists designed to integrating psychosocial factors in clinical practice on a patient level Receives: Behavioral: an eight day university training course designed to integrating psychosocial factors in clinical practice on a patient level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Measured: treatment start and 6 month follow up
Secondary outcomes (4)
catastrophizing
Measured: treatment start and 6 month follow up
treatment satisfaction
Measured: 6 month follow up
satisfaction with treatment result
Measured: 6 month follow up
Pain
Measured: treatment start and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startSep 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Collaborators
- Örebro University, Sweden, School of Law, Psychology, and Social Work, Örebro University, Sweden
- Investigators
- Steven J Linton, PH.D., Study director, Center for Health and Medical Psychology and School of Law, Psychology, and Social Work, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902642
- Sponsor's protocol ID
- M-127
- Status last verified
- May 2009
- First submitted
- 13 May 2009
- Last updated
- 15 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Overmeer T, Boersma K, Denison E, Linton SJ. Does teaching physical therapists to deliver a biopsychosocial treatment program result in better patient outcomes? A randomized controlled trial. Phys Ther. 2011 May;91(5):804-19. doi: 10.2522/ptj.20100079. Epub 2011 Mar 30.
PubMed 21451098
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Training in Psychosocial Methods for Treatment Providers Improve Outcome for Pain Patients at Risk of Long-Term Disability? A Randomised Controlled Trail of a Course for Physical Therapists
- ClinicalTrials.gov ID
- NCT00902642
- Acronym / sponsor ID
- M-127
- Conditions
- Pain
- Keywords
- Physical therapy,, musculoskeletal pain,, psychosocial factors,, dissimilation,, evidence based,, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Collaborators
- Örebro University, Sweden, School of Law, Psychology, and Social Work, Örebro University, Sweden
- Study start
- Sep 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 15 May 2009 (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.
The goal is to acquire more in-depth knowledge on physical therapists' attitudes towards and beliefs about psychosocial factors in back pain, how physical therapists integrate psychosocial factors into their clinical practice and the effects of a training program for physical therapists in psychosocial factors on clinical practice and thereby on patient outcome in terms of disability, pain, catastrophizing, and treatment satisfaction.
Detailed description
Neck and back pain continue to be extremely common, with a high prevalence and wide socio-economic consequences all over the industrialized world. Through the years a growing interest has risen for other factors than the pure biomedical or biomechanical. This has led to a new clinical model for the treatment of back pain; the biopsychosocial model of illness. Treatment based on the biopsychosocial model not only must address the biological basis of symptoms, but must incorporate the full range of social and psychological factors that have been shown to affect pain, distress and disability.
Since there is today strong evidence indicating that psychosocial factors have a greater impact on disability then biomechanical or biomedical factors and strong evidence that psychosocial factors are strongly linked to the transition from acute to chronic pain, concept of psychosocial risk factors has been developed. Although the concept of psychosocial risk factors still is relatively new, there seems to be an international consensus about the importance of psychosocial risk factors for the prevention of the development of chronic pain but there appears to be considerable uncertainty about the clinical application.
Health care providers' (HCPs') attitudes and beliefs appear to influence the information they provide to patients. This may subsequently result in different patient outcome depending on the HCPs' attitudes and beliefs. Physical therapists attitudes and beliefs are relatively unexplored but seem to have an effect on patients' attitudes and beliefs, which can affect patient outcome in terms of sick leave, health care use and function.
HCP attitudes and beliefs towards psychosocial factors are relatively unexplored. Yet, it seems physical therapists do not necessarily accept new evidence-based information and may have difficulties in applying evidence-based information in their clinical practice. Implementation and dissemination of evidence-based psychosocial factors requires favourable attitudes, knowledge and skills to ensure a behavioural change on behave of the physical therapists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| Course on psychosocial factors | Active comparator | Behavioral: an eight day university training course designed to integrating psychosocial factors in clinical practice on a patient levelan eight day university training course for physical therapists designed to integrating psychosocial factors in clinical practice on a patient level |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Musculoskeletal pain,
- Age between 18 and 65
Key exclusion criteria (1 listed)
- Sick leave for more than 3 months during the past year as a result of present the musculoskeletal pain problem
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 |
|---|---|---|
| an eight day university training course designed to integrating psychosocial factors in clinical practice on a patient levelan eight day university training course on psychosocial factors for physical therapists | Behavioural | Course on psychosocial factors |
Primary outcome
Disability
Time frame: treatment start and 6 month follow up
4 secondary outcomes
catastrophizing
Time frame: treatment start and 6 month follow up
treatment satisfaction
Time frame: 6 month follow up
satisfaction with treatment result
Time frame: 6 month follow up
Pain
Time frame: treatment start and 6 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2009.
- Derived from this study: PubMed 21451098Overmeer T, Boersma K, Denison E, Linton SJ. Does teaching physical therapists to deliver a biopsychosocial treatment program result in better patient outcomes? A randomized controlled trial. Phys Ther. 2011 May;91(5):804-19. doi: 10.2522/ptj.20100079. Epub 2011 Mar 30.
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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.
Steven J Linton, PH.D. study director
Center for Health and Medical Psychology and School of Law, Psychology, and Social Work, Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing an eight day university training course designed to integrating psychosocial factors in clinical practice on a patient level in people with Pain, run by Örebro County Council 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 15 May 2009. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disability (time frame: treatment start and 6 month follow up). 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 NCT00902642, which also lists 1 linked publication.
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 15 May 2009.