Low Back PainBetterBackNCT03147300

Implementation of a Best Practice Primary Health Care Model for Low Back Pain

A study testing Current routine practice and Multifaceted implementation of the BetterBack in people with Low Back Pain, run by Linkoeping University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

POPULATION: Low back pain (LBP) is a major health problem commonly requiring health care. In Sweden, primary care professionals require an evidenced based model of care for LBP. INTERVENTION: The multi-faceted implementation of a best practice BetterBack model of care for LBP. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Low Back Pain
What is being tested?: Current routine practice and Multifaceted implementation of the BetterBack
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 467 participants
Where: 1 siteSweden
Study dates: 1 Apr 2017to 31 Mar 2019
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

Registered physiotherapists practicing in the allocated clinics and regularly working with patients with LBP
Patient sample
Males and females 18-65 years; Fluent in Swedish; Accessing public primary care due to a current episode of a first-time or recurrent debut of benign low back pain with or without radiculopathy

Who cannot join

Current diagnosis of malignancy, spinal fracture, infection, cauda equine syndrome, ankylosing spondylitis or systemic rheumatic disease, previous malignancy during the past 5 years; Current pregnancy or previous pregnancy up to 3 months before consideration of inclusion; Patients that fulfill criteria for multimodal/multi-professional rehabilitation for complex longstanding pain; Severe psychiatric diagnosis

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Östergötland health care region
Linköping, 58191

Other trials in Sweden

About this study

Official title: Implementation of a Best Practice Primary Health Care Model for Low Back Pain in Sweden (BetterBack): A Cluster Randomised Trial

POPULATION: Low back pain (LBP) is a major health problem commonly requiring health care. In Sweden, primary care professionals require an evidenced based model of care for LBP.

INTERVENTION: The multi-faceted implementation of a best practice BetterBack model of care for LBP.

CONTROL: Current routine practice for LBP care before implementation of the BetterBack model of care.

OUTCOME: Patient reported measures (function, activity, health), therapist reported measures (diagnosis, intervention, specialist referral, best practice self-confidence, determinants of implementation) and cost-effectiveness.

AIM: To deliver best practice recommendations for LBP and study their most effective implementation through the BetterBack model of care.

METHOD: A cluster randomised trial with dog leg design. The hypothesis is that the BetterBack model of care will result in significantly better patient and therapist outcomes as well as cost-effectiveness compared to current routine care.

Read the detailed description

Low back pain (LBP) is a major health and socioeconomic burden. LBP is usually a result of benign dysfunction and context that affects the patient's perception of pain and limits their activity and participation. At present there are no national clinical guidelines or best practice models of care in Sweden focused on the primary care of low back pain. Implementation of a model of LBP primary care based on international evidence-based guidelines is needed to improve care and patient outcomes in Sweden. This project aims to investigate the effectiveness of a best practice model of care (BetterBack) for the primary care management of LBP. A cluster randomised trial with dog leg design will be conducted in the Östergötland Health care region. The hypothesis is that the BetterBack model of care will result in significantly better patient and therapist reported outcomes as well as cost-effectiveness compared to current routine care. This by improved patient outcomes in terms of physical function, low back pain intensity, activity level, work and quality of life. Furthermore, improved care processes and knowledge support for physiotherapists can lead to a smaller proportion of patients requiring specialist care.

Conditions: Low Back Pain
Being tested: Current routine practice, Multifaceted implementation of the BetterBack
Keywords: Low back pain, Model of care, Primary health care, Implementation, Patient-rated outcome, Clinician-rated outcome, Cost-effectiveness
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Current routine practiceBehavioural
Current routine practice for the primary care management of LBP
Multifaceted implementation of the BetterBackBehavioural
The multifaceted intervention is composed of the following:
1. Forming an implementation forum including head of departments/managers of the rehabilitation units and the clinical researchers.
2. Forming a support team comprised of experience clinicians as local supervisors and faculty researchers as knowledge facilitators.
3. Developing the Betterback model of care through a collaboration of the implementation forum, support team and international experts.
4. Forming and delivering a 2-day package of education and training that the support team can utilize to assist the use of the BetterBack model of care by clinicians.

Study groups in NCT03147300
Study group	Role	What they receive
Östergötland region - Control group	Active comparator	Not described Receives: Behavioral: Current routine practice
Östergötland region - Intervention group	Experimental	Not described Receives: Behavioral: Multifaceted implementation of the BetterBack

What is being measured

The primary outcome is the main question the study is designed to answer.

Numeric rating scale (NRS) for lower back related pain intensity during the latest week
Patient rated 11-point scale consisting of integers from 0 through 10; 0 representing ''No pain'' and 10 representing ''Worst imaginable pain''
Measured: Change between baseline and 3 months post baseline
Oswestry disability index (ODI) version 2.1
Patient rating of LBP disability analysed as a 0 to100 scale variable where lower scores represent lower levels of low back pain disability.
Measured: Change between baseline and 3 months post baseline
Practitioner Confidence Scale (PCS)
A total of 4 items are reported by the practitioner and a total score is collated where 4 represents greatest self-confidence and 20 represents lowest self-confidence
Measured: Change between baseline and 3 months post baseline
Incidence of participating patients recieving specialist care
Data on the number of participants accessing specialist care for LBP will be extracted from the Östergötland public health care region registry.
Measured: 12 months after baseline

Secondary outcomes (10)

Numeric rating scale (NRS) for lower back related pain intensity during the latest week
Patient rated 11-point scale consisting of integers from 0 through 10; 0 representing ''No pain'' and 10 representing ''Worst imaginable pain''
Measured: Baseline, 3, 6 and 12 months
Oswestry disability index (ODI) version 2.1
Patient rating of LBP disability analysed as a 0 to100 scale variable where lower scores represent lower levels of low back pain disability.
Measured: Baseline, 3, 6 and 12 months
The European Quality of Life Questionnaire (EQ-5D)
Patient rating of health-related quality of life and is computed into a 0 to 1.00 scale from worst to best possible health state by using UK index tariffs.
Measured: Baseline, 3, 6 and 12 months
The Brief Illness Perception Questionnaire (BIPQ)
Patient rating of cognitive illness representations (consequences, outcome expectancy, personal control, treatment control, and knowledge), emotional representations (concern and emotions) as well as illness comprehensibility. An overall score 0-80 represents the degree to which the LBP is perceived as threatening or benign where a higher score reflects a more threatening view of the illness
Measured: Baseline, 3, 6 and 12 months
Patient Enablement Index (PEI)
Patient rating of enablement with a score range between 0 and 12 with a higher score intended to reflect higher patient self-care enablement
Measured: 3, 6 and 12 months
Patient satisfaction
Patient rating of satisfaction asking "Over the course of treatment for this episode of low back pain or leg pain, how satisfied were you with the care provided by your health-care provider?" Were you very satisfied (1), somewhat satisfied (2), neither satisfied nor dissatisfied (3), somewhat dissatisfied (4), or very dissatisfied (5)?''
Measured: 3, 6 and 12 months
Patient global rating of change (PGIC)
Patient rating of the degree of change in LBP related problems from the beginning of treatment to the present. This is measured with a balanced 11 point numerical scale.
Measured: 3, 6 and 12 months
Practitioner Confidence Scale (PCS)
A total of 4 items are reported by the practitioner and a total score is collated where 4 represents greatest self-confidence and 20 represents lowest self-confidence
Measured: Baseline, directly after commencement of implementation strategy and at 3 and 12 months afterwards
Clinician rated health care process measures
Grade of patient functional impairment and activity limitation according to the ICF brief core set for LBP is assesses by the physiotherapist where light, moderate, severe and very severe impairment/limitation is coded 0-4 respectively. A total score for baseline and an additional total score for follow-up measures at the final clinical contact (up to 3 months after baseline) is calculated from the sum of the functional impairments divided by the number of functional impairments and a similar total score is calculated for activity limitations. At the final clinical contact the therapists also report the ICD-10 diagnosis codes as well as type and number of patient treatment interventions.
Measured: Baseline and final clinical contact (Up to 3 months where the time point is variable depending upon the amount of clinical contact required for each patient)
Pain Attitudes and Beliefs Scale for physical therapists (PABS-PT)
The PABS-PT consists of two factors where higher scores represent more treatment orientation regarding that factor, one measuring the biomedical treatment orientation (Score 0-60) and one regarding the biopsychosocial treatment orientation (Score 0-54)
Measured: Baseline, directly after education and at 3 and 12 months afterwards

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201731 Mar 2019

First posted10 May 2017
Study start1 Apr 2017
Primary completion31 Mar 2019
Study completion31 Mar 2019

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 Low Back PainStudies of the same condition, open and under way.
More trials run by Linkoeping 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: Health services research
Allocation: Randomised
Intervention model: Sequential
Model description: A cluster randomised trial with dog leg design
Masking: Single blind
Who is masked: Participant
Enrolment: 467 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03147300
Sponsor's protocol ID: BetterBack
Acronym: BetterBack
Status last verified: Aug 2019
First submitted: 3 May 2017
Last updated: 14 Aug 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Schroder K, Oberg B, Enthoven P, Kongsted A, Abbott A. Confidence, attitudes, beliefs and determinants of implementation behaviours among physiotherapists towards clinical management of low back pain before and after implementation of the BetterBack model of care. BMC Health Serv Res. 2020 May 19;20(1):443. doi: 10.1186/s12913-020-05197-3.
PubMed 32430047
Abbott A, Schroder K, Enthoven P, Nilsen P, Oberg B. Effectiveness of implementing a best practice primary healthcare model for low back pain (BetterBack) compared with current routine care in the Swedish context: an internal pilot study informed protocol for an effectiveness-implementation hybrid type 2 trial. BMJ Open. 2018 Apr 24;8(4):e019906. doi: 10.1136/bmjopen-2017-019906.
PubMed 29691246

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of a Best Practice Primary Health Care Model for Low Back Pain in Sweden (BetterBack): A Cluster Randomised Trial
ClinicalTrials.gov ID: NCT03147300
Acronym / sponsor ID: BetterBack / BetterBack
Conditions: Low Back Pain
Keywords: Low back pain, Model of care, Primary health care, Implementation, Patient-rated outcome, Clinician-rated outcome, Cost-effectiveness
Study type: Interventional
Recruitment status: Completed
Enrolment: 467 participants (actual)
Lead sponsor: Linkoeping UniversityOther government
Study start: 1 Apr 2017 (actual)
Primary completion: 31 Mar 2019 (actual)
Study completion: 31 Mar 2019 (actual)
First posted: 10 May 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.

POPULATION: Low back pain (LBP) is a major health problem commonly requiring health care. In Sweden, primary care professionals require an evidenced based model of care for LBP.

INTERVENTION: The multi-faceted implementation of a best practice BetterBack model of care for LBP.

CONTROL: Current routine practice for LBP care before implementation of the BetterBack model of care.

AIM: To deliver best practice recommendations for LBP and study their most effective implementation through the BetterBack model of care.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 2
Model description: A cluster randomised trial with dog leg design

Arm	Type	Receives
Östergötland region - Control group	Active comparator	Behavioral: Current routine practice
Östergötland region - Intervention group	Experimental	Behavioral: Multifaceted implementation of the BetterBack

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Registered physiotherapists practicing in the allocated clinics and regularly working with patients with LBP
Patient sample
Males and females 18-65 years; Fluent in Swedish; Accessing public primary care due to a current episode of a first-time or recurrent debut of benign low back pain with or without radiculopathy

Key exclusion criteria (1 listed)

Current diagnosis of malignancy, spinal fracture, infection, cauda equine syndrome, ankylosing spondylitis or systemic rheumatic disease, previous malignancy during the past 5 years; Current pregnancy or previous pregnancy up to 3 months before consideration of inclusion; Patients that fulfill criteria for multimodal/multi-professional rehabilitation for complex longstanding pain; Severe psychiatric diagnosis

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
Current routine practiceCurrent routine practice for the primary care management of LBP	Behavioural	Östergötland region - Control group
Multifaceted implementation of the BetterBackThe multifaceted intervention is composed of the following: 1. Forming an implementation forum including head of departments/managers of the rehabilitation units and the clinical researchers. 2. Forming a support team comprised of experience clinicians as local supervisors and faculty researchers as knowledge facilitators. 3. Developing the Betterback model of care through a collaboration of the implementation forum, support team and international experts. 4. Forming and delivering a 2-day package of education and training that the support team can utilize to assist the use of the BetterBack model of care by clinicians.	Behavioural	Östergötland region - Intervention group

Primary outcome

Numeric rating scale (NRS) for lower back related pain intensity during the latest week
Time frame: Change between baseline and 3 months post baseline
Patient rated 11-point scale consisting of integers from 0 through 10; 0 representing ''No pain'' and 10 representing ''Worst imaginable pain''
Oswestry disability index (ODI) version 2.1
Time frame: Change between baseline and 3 months post baseline
Patient rating of LBP disability analysed as a 0 to100 scale variable where lower scores represent lower levels of low back pain disability.
Practitioner Confidence Scale (PCS)
Time frame: Change between baseline and 3 months post baseline
A total of 4 items are reported by the practitioner and a total score is collated where 4 represents greatest self-confidence and 20 represents lowest self-confidence
Incidence of participating patients recieving specialist care
Time frame: 12 months after baseline
Data on the number of participants accessing specialist care for LBP will be extracted from the Östergötland public health care region registry.

10 secondary outcomes

Numeric rating scale (NRS) for lower back related pain intensity during the latest week
Time frame: Baseline, 3, 6 and 12 months
Oswestry disability index (ODI) version 2.1
Time frame: Baseline, 3, 6 and 12 months
The European Quality of Life Questionnaire (EQ-5D)
Time frame: Baseline, 3, 6 and 12 months
The Brief Illness Perception Questionnaire (BIPQ)
Time frame: Baseline, 3, 6 and 12 months
Patient Enablement Index (PEI)
Time frame: 3, 6 and 12 months
Patient satisfaction
Time frame: 3, 6 and 12 months
Patient global rating of change (PGIC)
Time frame: 3, 6 and 12 months
Practitioner Confidence Scale (PCS)
Time frame: Baseline, directly after commencement of implementation strategy and at 3 and 12 months afterwards
Clinician rated health care process measures
Time frame: Baseline and final clinical contact (Up to 3 months where the time point is variable depending upon the amount of clinical contact required for each patient)
Pain Attitudes and Beliefs Scale for physical therapists (PABS-PT)
Time frame: Baseline, directly after education and at 3 and 12 months afterwards

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 14 Aug 2019.
Derived from this study: PubMed 32430047Schroder K, Oberg B, Enthoven P, Kongsted A, Abbott A. Confidence, attitudes, beliefs and determinants of implementation behaviours among physiotherapists towards clinical management of low back pain before and after implementation of the BetterBack model of care. BMC Health Serv Res. 2020 May 19;20(1):443. doi: 10.1186/s12913-020-05197-3.
Derived from this study: PubMed 29691246Abbott A, Schroder K, Enthoven P, Nilsen P, Oberg B. Effectiveness of implementing a best practice primary healthcare model for low back pain (BetterBack) compared with current routine care in the Swedish context: an internal pilot study informed protocol for an effectiveness-implementation hybrid type 2 trial. BMJ Open. 2018 Apr 24;8(4):e019906. doi: 10.1136/bmjopen-2017-019906.
Individual participant dataSharing planned: No

Related trials for Low Back Pain

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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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.

Allan Abbott, Msc Physio, PhD principal investigator

Linkoeping University

Birgitta Abbott, MSc Physio, PhD principal investigator

Linkoeping University

Paul Enthoven, MSc Physio, PhD study chair

Linkoeping 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 Current routine practice and Multifaceted implementation of the BetterBack in people with Low Back Pain, run by Linkoeping 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 3 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 14 Aug 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 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?

Numeric rating scale (NRS) for lower back related pain intensity during the latest week (time frame: Change between baseline and 3 months post baseline). The study lists 4 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 NCT03147300, 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 14 Aug 2019.