Musculoskeletal PainNCT01475591
Individually Tailored Web-based Multimodal Pain Rehabilitation in Primary Health Care
A study testing Web-based multimodal rehabilitation based on cognitive based principles in people with Musculoskeletal Pain, run by Luleå Tekniska Universitet at 1 site in Sweden.
Trial summary
The aim is to evaluate effects of early individually tailored web-based multimodal rehabilitation for persons with musculoskeletal neck/shoulder and back disorders in primary health care. Read more about this study
- Who is it for?
- Ages 18 to 63 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Web-based multimodal rehabilitation based on cognitive based principles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to Jun 2015
- 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 63 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- With persistent neuromusculoskeletal pain from the neck/shoulder/back-area and/or fibromyalgia and a screening
- > 90 on Lintons´ questionnaire, The Örebro Musculoskeletal Pain Questionnaire (Linton \& Halldén., 1998; Hockings et.al., 2008)
- Fluent in Swedish language
- Working, or in disposition to at least 25%
Who cannot join
- Dementia
- Restricted cognitive functioning
- Comorbidity which might prevent treatment participation
- Identified abuse, retirement pension
- Ongoing causal treatment
- Pregnancy
- Patients lacking internet attached computers in their home
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Primary health care centers in Norrbotten county council
Luleå, Norrbotten County
About this study
The aim is to evaluate effects of early individually tailored web-based multimodal rehabilitation for persons with musculoskeletal neck/shoulder and back disorders in primary health care. The aim is also to study if this early web-based pain rehabilitation program is more cost-effective than only multimodal rehabilitation. Randomization will be done at each primary health care centre after screening to 1) Multimodal pain rehabilitation with web-based education and coaching support or 2) multimodal pain rehabilitation. The investigators suggest a clear rehabilitation chain where a web-based program is developed,evaluated and ready to implement if it shows positive effects on work-ability and/or is cost-effective. The research and implementation will be performed in a close cooperation with Luleå University of Technology.
- Conditions
- Musculoskeletal Pain
- Being tested
- Web-based multimodal rehabilitation based on cognitive based principles
- Keywords
- persistent neuromusculoskeletal pain, neck, shoulder, back-area, risk, longlasting, pain syndrome
- Medical subject headings
- Musculoskeletal Pain, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based multimodal rehabilitation based on cognitive based principlesBehavioural
The patient will be randomized to either the interventions group (multimodal pain rehabilitation with an added web-based multimodal rehabilitation with CBT-influences) or a control group (multimodal pain rehabilitation).
| Study group | Role | What they receive |
|---|---|---|
| Multimodal rehabilitation | No intervention | The arm intervention is just multimodal rehabilitation. Receives: Behavioral: Web-based multimodal rehabilitation based on cognitive based principles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work ability
Measured: 4 month
Secondary outcomes (4)
Pain rating
Pain-rating is measured on a visual analog-scale
Measured: 12 month
Self-efficacy in relation to workability
Self-efficacy in relation to work-ability is measured by a questionnarie
Measured: 12 month
General health
General health is measured with SF-36 and EQ-5D.
Measured: 12 month
Functional status
Functional status is measured with Pain disability index.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal 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
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luleå Tekniska Universitet
- Sponsor type
- University, hospital or other
- Collaborators
- Norrbottens County Council
- Responsible party
- Principal investigator, Peter Michaelson, Luleå Tekniska Universitet
- Investigators
- Gunvor Gard, Professor, Principal investigator, Luleå University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475591
- Sponsor's protocol ID
- REHSAM_NLL_LTU
- Status last verified
- Sep 2016
- First submitted
- 1 Nov 2011
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Calner T, Nordin C, Eriksson MK, Nyberg L, Gard G, Michaelson P. Effects of a self-guided, web-based activity programme for patients with persistent musculoskeletal pain in primary healthcare: A randomized controlled trial. Eur J Pain. 2017 Jul;21(6):1110-1120. doi: 10.1002/ejp.1012. Epub 2017 May 2.
PubMed 28464364Nordin CA, Michaelson P, Gard G, Eriksson MK. Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial. J Med Internet Res. 2016 Oct 5;18(10):e265. doi: 10.2196/jmir.5634.
PubMed 27707686
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Tailored Web-based Multimodal Pain Rehabilitation in Primary Health Care
- ClinicalTrials.gov ID
- NCT01475591
- Acronym / sponsor ID
- REHSAM_NLL_LTU
- Conditions
- Musculoskeletal Pain
- Keywords
- persistent neuromusculoskeletal pain, neck, shoulder, back-area, risk, longlasting, pain syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Luleå Tekniska UniversitetUniversity, hospital or other
- Collaborators
- Norrbottens County Council
- Study start
- Oct 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Nov 2011 (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 aim is to evaluate effects of early individually tailored web-based multimodal rehabilitation for persons with musculoskeletal neck/shoulder and back disorders in primary health care. The aim is also to study if this early web-based pain rehabilitation program is more cost-effective than only multimodal rehabilitation. Randomization will be done at each primary health care centre after screening to 1) Multimodal pain rehabilitation with web-based education and coaching support or 2) multimodal pain rehabilitation. The investigators suggest a clear rehabilitation chain where a web-based program is developed,evaluated and ready to implement if it shows positive effects on work-ability and/or is cost-effective. The research and implementation will be performed in a close cooperation with Luleå University of Technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal rehabilitation | No intervention | Behavioral: Web-based multimodal rehabilitation based on cognitive based principlesThe arm intervention is just multimodal rehabilitation. |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- With persistent neuromusculoskeletal pain from the neck/shoulder/back-area and/or fibromyalgia and a screening
- > 90 on Lintons´ questionnaire, The Örebro Musculoskeletal Pain Questionnaire (Linton \& Halldén., 1998; Hockings et.al., 2008)
- Fluent in Swedish language
- Working, or in disposition to at least 25%
Key exclusion criteria (7 listed)
- Dementia
- Restricted cognitive functioning
- Comorbidity which might prevent treatment participation
- Identified abuse, retirement pension
- Ongoing causal treatment
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 |
|---|---|---|
| Web-based multimodal rehabilitation based on cognitive based principlesThe patient will be randomized to either the interventions group (multimodal pain rehabilitation with an added web-based multimodal rehabilitation with CBT-influences) or a control group (multimodal pain rehabilitation). | Behavioural | Multimodal rehabilitation |
Primary outcome
Work ability
Time frame: 4 month
4 secondary outcomes
Pain rating
Time frame: 12 month
Self-efficacy in relation to workability
Time frame: 12 month
General health
Time frame: 12 month
Functional status
Time frame: 12 month
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 23 Sep 2016.
- Derived from this study: PubMed 28464364Calner T, Nordin C, Eriksson MK, Nyberg L, Gard G, Michaelson P. Effects of a self-guided, web-based activity programme for patients with persistent musculoskeletal pain in primary healthcare: A randomized controlled trial. Eur J Pain. 2017 Jul;21(6):1110-1120. doi: 10.1002/ejp.1012. Epub 2017 May 2.
- Derived from this study: PubMed 27707686Nordin CA, Michaelson P, Gard G, Eriksson MK. Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial. J Med Internet Res. 2016 Oct 5;18(10):e265. doi: 10.2196/jmir.5634.
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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.
Gunvor Gard, Professor principal investigator
Luleå University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based multimodal rehabilitation based on cognitive based principles in people with Musculoskeletal Pain, run by Luleå Tekniska Universitet 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 4 inclusion and 7 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 23 Sep 2016. 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?
Work ability (time frame: 4 month). 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 NCT01475591, which also lists 2 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 23 Sep 2016.