Musculoskeletal Neck PainNCT01447953
Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care
A study testing Activity targeted pain rehabilitation and Treatment as usual in people with Musculoskeletal Neck Pain and Musculoskeletal Shoulder Pain, run by Uppsala University at 1 site in Sweden.
Trial summary
The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Musculoskeletal Neck Pain, Musculoskeletal Shoulder Pain
- What is being tested?
- Activity targeted pain rehabilitation and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Persons seeking primary health care due to back, neck or shoulder pain
- Aged 18 to 60 years
- Being on sick leave or disability compensation
- Able to understand, read and write Swedish
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The County Council of Dalarna; Primary Health Care units
Falun, 79182
About this study
Official title: Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care: a Randomized Controlled Trial
The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to administer in primary care. A new activity and life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. The program will be implemented and provided as one of the pain treatment modalities available through multi-professional teams in primary care in one Swedish county. This study aims to evaluate the effect of an activity and life-role targeting pain rehabilitation program on the outcome variables return-to-work and sickness absence.
Read the detailed description
The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to administer in primary care. A new activity and life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. The program will be implemented and provided as one of the pain treatment modalities available through multi-professional teams in primary care in one Swedish county. This study aims to evaluate the effect of an activity and life-role targeting pain rehabilitation program on the outcome variables return-to-work and sickness absence.
Patients seeking care due to disabling back, neck or shoulder pain at seven primary health care units in the County of Dalarna, Sweden, was randomly allocated to ALAR or usual multimodal rehabilitation. Between and within-group differences on return-to-work, sickness absence and disability will be evaluated at 10 weeks, six months, one and two years post-treatment.
The enrollment of patients was ended on preterm in june 2013. Due to changes in the organization in primary health care it was no longer possible to ensure that treatment arms could be delivered as intended. Data collection up to 1-year follow-up is completed. Data from longterm follow-up at 2 years will be completed in june 2015. Data analyses and reporting of results is presently undertaken. The number of enrolled participants is not enough to reach statistical power. Thus, results will need to be interpreted with caution.
Still the results of this pragmatic study will be of importance for the planning of a full scale study to accurately evaluate the effects of ALAR, to be conducted in primary care.
- Being tested
- Activity targeted pain rehabilitation, Treatment as usual
- Keywords
- Activity, disability, life-role, multimodal rehabilitation, primary health care, persistent pain, randomized controlled trial, Musculoskeletal back pain
- Medical subject headings
- Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity targeted pain rehabilitationOther
An activity and life-role targeting rehabilitation programme (ALAR) provided by one of the care givers in the multi-professional rehabilitation teams at each of the eight participating primary health care centres, by ten weekly 1-hour treatment sessions.
Treatment as usualOther
Usual treatment with type of treatment modalities, number, frequency and duration of visits according to the judgement of the muli-professional teams at each primary health care centre.
| Study group | Role | What they receive |
|---|---|---|
| Activity targeted pain rehabilitation | Experimental | A new activity and life-role targeting pain rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. Receives: Other: Activity targeted pain rehabilitation |
| Treatment as usual | Active comparator | Usual treatment consisting of multimodal rehabilitation provided by multi-professional teams in primary health care in the County of Dalarna, Sweden. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days of sickness absence from work
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
Measured: 6 months
Number of days of sickness absence from work
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
Measured: 1 year
Number of days of sickness absence from work
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
Measured: 2 years
Secondary outcomes (2)
Return-to-work after sickness absence
Number of participants that return to work after sickness absence, i.e. that were on sick leave before the study and that has returned to work after the study.
Measured: Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
Disability
Pain-related disability according to Pain Disability Index (PDI).
Measured: Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJun 2015
Why it stopped: Organizational changes in health care made further recruitment to the treatment options unpossible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal Neck 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Clinical Research Dalarna, Sweden, Dalarna County Council, Sweden, REHSAM, Sweden
- Responsible party
- Principal investigator, Catharina Gustavsson, RPT PhD, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447953
- Sponsor's protocol ID
- ALAR-2009RS
- Status last verified
- Dec 2015
- First submitted
- 9 Sep 2011
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01447953
- Acronym / sponsor ID
- ALAR-2009RS
- Keywords
- Activity, disability, life-role, multimodal rehabilitation, primary health care, persistent pain, randomized controlled trial, Musculoskeletal back pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Organizational changes in health care made further recruitment to the treatment options unpossible.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Center for Clinical Research Dalarna, Sweden, Dalarna County Council, Sweden, REHSAM, Sweden
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Oct 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 primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to administer in primary care. A new activity and life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. The program will be implemented and provided as one of the pain treatment modalities available through multi-professional teams in primary care in one Swedish county. This study aims to evaluate the effect of an activity and life-role targeting pain rehabilitation program on the outcome variables return-to-work and sickness absence.
Detailed description
The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to administer in primary care. A new activity and life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. The program will be implemented and provided as one of the pain treatment modalities available through multi-professional teams in primary care in one Swedish county. This study aims to evaluate the effect of an activity and life-role targeting pain rehabilitation program on the outcome variables return-to-work and sickness absence.
Patients seeking care due to disabling back, neck or shoulder pain at seven primary health care units in the County of Dalarna, Sweden, was randomly allocated to ALAR or usual multimodal rehabilitation. Between and within-group differences on return-to-work, sickness absence and disability will be evaluated at 10 weeks, six months, one and two years post-treatment.
The enrollment of patients was ended on preterm in june 2013. Due to changes in the organization in primary health care it was no longer possible to ensure that treatment arms could be delivered as intended. Data collection up to 1-year follow-up is completed. Data from longterm follow-up at 2 years will be completed in june 2015. Data analyses and reporting of results is presently undertaken. The number of enrolled participants is not enough to reach statistical power. Thus, results will need to be interpreted with caution.
Still the results of this pragmatic study will be of importance for the planning of a full scale study to accurately evaluate the effects of ALAR, to be conducted in primary care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity targeted pain rehabilitation | Experimental | Other: Activity targeted pain rehabilitationA new activity and life-role targeting pain rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. |
| Treatment as usual | Active comparator | Other: Treatment as usualUsual treatment consisting of multimodal rehabilitation provided by multi-professional teams in primary health care in the County of Dalarna, Sweden. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Persons seeking primary health care due to back, neck or shoulder pain
- Aged 18 to 60 years
- Being on sick leave or disability compensation
- Able to understand, read and write Swedish
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Activity targeted pain rehabilitationAn activity and life-role targeting rehabilitation programme (ALAR) provided by one of the care givers in the multi-professional rehabilitation teams at each of the eight participating primary health care centres, by ten weekly 1-hour treatment sessions. | Other | Activity targeted pain rehabilitation |
| Treatment as usualUsual treatment with type of treatment modalities, number, frequency and duration of visits according to the judgement of the muli-professional teams at each primary health care centre. | Other | Treatment as usual |
Primary outcome
Number of days of sickness absence from work
Time frame: 6 months
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
Number of days of sickness absence from work
Time frame: 1 year
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
Number of days of sickness absence from work
Time frame: 2 years
Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
2 secondary outcomes
Return-to-work after sickness absence
Time frame: Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
Disability
Time frame: Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
Results and safety
The study was stopped early (reason given: Organizational changes in health care made further recruitment to the treatment options unpossible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity targeted pain rehabilitation and Treatment as usual in people with Musculoskeletal Neck Pain and Musculoskeletal Shoulder 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 4 inclusion and 0 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 15 Dec 2015. 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: Organizational changes in health care made further recruitment to the treatment options unpossible.). 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?
Number of days of sickness absence from work (time frame: 6 months). 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?
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 Dec 2015.