BackpainALIGNNCT07825116
Implementation of Evidence-based Guidelines for Assessment and Counseling of Patients With Neck and Back Pain in Health Care Centers
A study testing Manual terapeut management in people with Backpain and Neck and Shoulder Pain, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The overall aim is to investigate the health outcomes and consequences, from an individual and a societal perspective, of adding licensed Manual Therapists as first-contact healthcare providers in Primary Health Care centers to triage (not treat) patients seeking care for Neck and Back Pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Backpain, Neck and Shoulder Pain
- What is being tested?
- Manual terapeut management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18-70 years, with an appointment with a physician at the primary health care center for a new episode of pain or discomfort in the neck, mid-back or lower back with or without radiating symptoms to the head, arms, or leg
Who cannot join
- Sick-leave for neck- and backpain the preceding three months (at least 50%), having consulted or been treated by licensed healthcare provider for neck- and backpain during the preceding three months, and not mastering the Swedish language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Karolinska Institutet , Stockholm 171 77 Solna
Stockholm
Iben Axén, PhD, +46 70 44 00 618, iben.axen@ki.se
About this study
The overall aim is to investigate the health outcomes and consequences, from an individual and a societal perspective, of adding licensed Manual Therapists as first-contact healthcare providers in Primary Health Care centers to triage (not treat) patients seeking care for Neck and Back Pain.
A hybrid, quasi-experimental Target Trial Emulation design employing mixed methods contextualized to participating Primary Health Care centers will be used.
Read more
Neck and Back Pain patients with a physician's appointment at a participating Primary Health Care center will be included and followed one year;
- 300 patients with care as usual who see their physician (control group),
- 300 patients who see a licensed naprapath/chiropractor for an initial evidence-based assessment/screening before the physicians' visit.
Patient outcomes include recovery, function and work ability, as well as health economy are compared between the groups.
Read the detailed description
Many visits to primary healthcare centers (PHCs) concern neck and/or back pain (NBP). Evidence-based clinical guidelines are often not considered, and low-value care, including unnecessary imaging, prescription of medications, injections, unnecessary surgery, and sick leave, is instead used, leading to poor patient outcomes and high societal costs. The primary healthcare system is severely pressured, and there is a need to reduce the burden of this common patient group on the physicians. Licensed naprapaths and chiropractors (manual therapist (MT)) have been part of Swedish healthcare for >30 years, but their competence is seldom utilized at PHCs. MT as first-contact providers within PHCs may reduce the burden of NBP in the population by improving adherence to evidence-based guidelines, reducing the workload on physicians, minimizing unnecessary healthcare procedures, and reducing expenditure.
Patient reported outcomes include pain, function, work ability and satisfaction, and health economy are based on sickness absence, care consumption, referrals and pharmaceutical use will be compared between groups.
Our hypothesis is that the intervention will lead to symptom improvement and work ability, as well as decrease the risk of sickness absence and low value care (sickness absence, care consumption, referrals and pharmaceutical use) for these patients. Thus, we hypothesize positive consequences for the individual and for society.
Advanced epidemiological/statistical methods address confounding when comparing the groups. Physicians' and patients' experiences, facilitators, and barriers to the implementation of the intervention will also be studied.
- Conditions
- Backpain, Neck and Shoulder Pain
- Being tested
- Manual terapeut management
- Keywords
- community health centers, eveidence-based practice, manual therapy, interprofessionalrealtions, low backpain, neckpain
- Medical subject headings
- Back Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual terapeut managementOther
The intervention in the index group is a triage performed by the licensed manual teerapeut: take the anamnesis, perform a clinical and assessment formula examination (fear/avoidance, pain catastrophizing, and expectations), provide a diagnosis, and give the patient recommendations according to current evidence-based clinical guidelines. The outcome in this intervention arm will be compared to study participants with "care as usal" included in sthe study earlier.
| Study group | Role | What they receive |
|---|---|---|
| MT management | Experimental | The intervention in the index group is a triage performed by the licensed manual therapist, MT: take the anamnesis, perform a clinical assessment and examination (including assessment of fear/avoidance, pain catastrophizing, and expectations), provide a diagnosis, and give the patient recommendations according to evidence-based clinical guidelines, i.e., high-value care. In summary, these guidelines state that patients with no "Red flags" (signs of pathology) or "Yellow flags" (psychological risk factors such as unrealistic beliefs about their pain, catastrophizing, kinesiophobia) shall self-manage when they are adequately informed about their condition and that they need to continue with their usual activities, such as work, physical activity, and social life. The role of the MT is to triage patients according to the best evidence into three groups: those with little or no risk of persistent pain, those with a moderate risk, and those with a substantial risk of a bad prognosis. Receives: Other: Manual terapeut management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-perceived Global Perceived Effect
This outcome is measured through a Lickert scale. The single question is: "compared with the start of the trial, how is your [condition] today?" Answers from "completely recovered" to "much worse"
Measured: 12 months
Secondary outcomes (6)
Chronic pain
Measured: 12 months
Activity limitations
Roland Morris disability questionnaire, Nordic pain questionnaire. These are validated instruments assessing the influence of the condition on everyday activities. Example "my [condition] prevents me from doing household chores" -agree/do not agree. The instrument then results in a score where high scores mean that the condition highly affects daily activities.
Measured: 12 months
Health-related quality of life
EuorQol-5 dimensions is a validated questionnaire that results in a score between 0 and 1(perfect health).
Measured: 12 months
Societal costs
Cost related to care consumption, sick-leave, referrals and pharmaceuticals. Self-reported every three months, participants are reporting all care relating to their condition, number of care visits and cost of visits. Travel time is attributed to each care visit. This will also include visits to specialists. They are reporting the number of days they have been off work due to the condition, and all type of medication consumed for their condition.
Measured: 12 months
Work Ability
Measures the balance between a person's individual resources (such as health, skills, and mental energy) and the actual demands of their job
Measured: 12 months
sickness absence
The number of days an individual has been off work because of neck and back pain
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for BackpainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Not applicable
- Intervention model
- Sequential
- Model description
- A hybrid, quasi-experimental Target Trial Emulation design employing mixed methods
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Sophiahemmet University
- Responsible party
- Principal investigator, Iben Axen, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825116
- Sponsor's protocol ID
- KIIMMIIB
- Acronym
- ALIGN
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In the planning stages of the trial, we have not taken measures to share data. This is due to our ethical permission.
Publications
Bornhoft L, Thorn J, Svensson M, Nordeman L, Eggertsen R, Larsson MEH. More cost-effective management of patients with musculoskeletal disorders in primary care after direct triaging to physiotherapists for initial assessment compared to initial general practitioner assessment. BMC Musculoskelet Disord. 2019 May 1;20(1):186. doi: 10.1186/s12891-019-2553-9.
PubMed 31043169Slade SC, Kent P, Patel S, Bucknall T, Buchbinder R. Barriers to Primary Care Clinician Adherence to Clinical Guidelines for the Management of Low Back Pain: A Systematic Review and Metasynthesis of Qualitative Studies. Clin J Pain. 2016 Sep;32(9):800-16. doi: 10.1097/AJP.0000000000000324.
PubMed 26710217Egerton T, Diamond LE, Buchbinder R, Bennell KL, Slade SC. A systematic review and evidence synthesis of qualitative studies to identify primary care clinicians' barriers and enablers to the management of osteoarthritis. Osteoarthritis Cartilage. 2017 May;25(5):625-638. doi: 10.1016/j.joca.2016.12.002. Epub 2016 Dec 7.
PubMed 27939622Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.
PubMed 29971708Wiitavaara B, Fahlstrom M, Djupsjobacka M. Prevalence, diagnostics and management of musculoskeletal disorders in primary health care in Sweden - an investigation of 2000 randomly selected patient records. J Eval Clin Pract. 2017 Apr;23(2):325-332. doi: 10.1111/jep.12614. Epub 2016 Aug 19.
PubMed 27538347Hallberg S, Rolfson O, Karppinen J, Schiottz-Christensen B, Stubhaug A, Rivano Fischer M, Gerdle B, Toresson Grip E, Gustavsson A, Robinson RL, Varenhorst C, Schepman P. Burden of disease and management of osteoarthritis and chronic low back pain: healthcare utilization and sick leave in Sweden, Norway, Finland and Denmark (BISCUITS): study design and patient characteristics of a real world data study. Scand J Pain. 2022 Jul 20;23(1):126-138. doi: 10.1515/sjpain-2021-0212. Print 2023 Jan 27.
PubMed 35858277Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, Turner JA, Maher CG; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018 Jun 9;391(10137):2368-2383. doi: 10.1016/S0140-6736(18)30489-6. Epub 2018 Mar 21.
PubMed 29573872Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.
PubMed 33275908GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
PubMed 33069326
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Evidence-based Guidelines for Assessment and Counseling of Patients With Neck and Back Pain in Health Care Centers
- ClinicalTrials.gov ID
- NCT07825116
- Acronym / sponsor ID
- ALIGN / KIIMMIIB
- Conditions
- Backpain, Neck and Shoulder Pain
- Keywords
- community health centers, eveidence-based practice, manual therapy, interprofessionalrealtions, low backpain, neckpain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Sophiahemmet University
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Sep 2026 (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.
The overall aim is to investigate the health outcomes and consequences, from an individual and a societal perspective, of adding licensed Manual Therapists as first-contact healthcare providers in Primary Health Care centers to triage (not treat) patients seeking care for Neck and Back Pain.
A hybrid, quasi-experimental Target Trial Emulation design employing mixed methods contextualized to participating Primary Health Care centers will be used.
Neck and Back Pain patients with a physician's appointment at a participating Primary Health Care center will be included and followed one year;
- 300 patients with care as usual who see their physician (control group),
- 300 patients who see a licensed naprapath/chiropractor for an initial evidence-based assessment/screening before the physicians' visit.
Patient outcomes include recovery, function and work ability, as well as health economy are compared between the groups.
Detailed description
Many visits to primary healthcare centers (PHCs) concern neck and/or back pain (NBP). Evidence-based clinical guidelines are often not considered, and low-value care, including unnecessary imaging, prescription of medications, injections, unnecessary surgery, and sick leave, is instead used, leading to poor patient outcomes and high societal costs. The primary healthcare system is severely pressured, and there is a need to reduce the burden of this common patient group on the physicians. Licensed naprapaths and chiropractors (manual therapist (MT)) have been part of Swedish healthcare for >30 years, but their competence is seldom utilized at PHCs. MT as first-contact providers within PHCs may reduce the burden of NBP in the population by improving adherence to evidence-based guidelines, reducing the workload on physicians, minimizing unnecessary healthcare procedures, and reducing expenditure.
Patient reported outcomes include pain, function, work ability and satisfaction, and health economy are based on sickness absence, care consumption, referrals and pharmaceutical use will be compared between groups.
Our hypothesis is that the intervention will lead to symptom improvement and work ability, as well as decrease the risk of sickness absence and low value care (sickness absence, care consumption, referrals and pharmaceutical use) for these patients. Thus, we hypothesize positive consequences for the individual and for society.
Advanced epidemiological/statistical methods address confounding when comparing the groups. Physicians' and patients' experiences, facilitators, and barriers to the implementation of the intervention will also be studied.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A hybrid, quasi-experimental Target Trial Emulation design employing mixed methods
| Arm | Type | Receives |
|---|---|---|
| MT management | Experimental | Other: Manual terapeut managementThe intervention in the index group is a triage performed by the licensed manual therapist, MT: take the anamnesis, perform a clinical assessment and examination (including assessment of fear/avoidance, pain catastrophizing, and expectations), provide a diagnosis, and give the patient recommendations according to evidence-based clinical guidelines, i.e., high-value care. In summary, these guidelines state that patients with no "Red flags" (signs of pathology) or "Yellow flags" (psychological risk factors such as unrealistic beliefs about their pain, catastrophizing, kinesiophobia) shall self-manage when they are adequately informed about their condition and that they need to continue with their usual activities, such as work, physical activity, and social life. The role of the MT is to triage patients according to the best evidence into three groups: those with little or no risk of persistent pain, those with a moderate risk, and those with a substantial risk of a bad prognosis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18-70 years, with an appointment with a physician at the primary health care center for a new episode of pain or discomfort in the neck, mid-back or lower back with or without radiating symptoms to the head, arms, or leg
Key exclusion criteria (1 listed)
- Sick-leave for neck- and backpain the preceding three months (at least 50%), having consulted or been treated by licensed healthcare provider for neck- and backpain during the preceding three months, and not mastering the Swedish language
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 |
|---|---|---|
| Manual terapeut managementThe intervention in the index group is a triage performed by the licensed manual teerapeut: take the anamnesis, perform a clinical and assessment formula examination (fear/avoidance, pain catastrophizing, and expectations), provide a diagnosis, and give the patient recommendations according to current evidence-based clinical guidelines. The outcome in this intervention arm will be compared to study participants with "care as usal" included in sthe study earlier. | Other | MT management |
Primary outcome
Patient-perceived Global Perceived Effect
Time frame: 12 months
This outcome is measured through a Lickert scale. The single question is: "compared with the start of the trial, how is your [condition] today?" Answers from "completely recovered" to "much worse"
6 secondary outcomes
Chronic pain
Time frame: 12 months
Activity limitations
Time frame: 12 months
Health-related quality of life
Time frame: 12 months
Societal costs
Time frame: 12 months
Work Ability
Time frame: 12 months
sickness absence
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 31043169Bornhoft L, Thorn J, Svensson M, Nordeman L, Eggertsen R, Larsson MEH. More cost-effective management of patients with musculoskeletal disorders in primary care after direct triaging to physiotherapists for initial assessment compared to initial general practitioner assessment. BMC Musculoskelet Disord. 2019 May 1;20(1):186. doi: 10.1186/s12891-019-2553-9.
- Background: PubMed 26710217Slade SC, Kent P, Patel S, Bucknall T, Buchbinder R. Barriers to Primary Care Clinician Adherence to Clinical Guidelines for the Management of Low Back Pain: A Systematic Review and Metasynthesis of Qualitative Studies. Clin J Pain. 2016 Sep;32(9):800-16. doi: 10.1097/AJP.0000000000000324.
- Background: PubMed 27939622Egerton T, Diamond LE, Buchbinder R, Bennell KL, Slade SC. A systematic review and evidence synthesis of qualitative studies to identify primary care clinicians' barriers and enablers to the management of osteoarthritis. Osteoarthritis Cartilage. 2017 May;25(5):625-638. doi: 10.1016/j.joca.2016.12.002. Epub 2016 Dec 7.
- Background: PubMed 29971708Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.
- Background: PubMed 27538347Wiitavaara B, Fahlstrom M, Djupsjobacka M. Prevalence, diagnostics and management of musculoskeletal disorders in primary health care in Sweden - an investigation of 2000 randomly selected patient records. J Eval Clin Pract. 2017 Apr;23(2):325-332. doi: 10.1111/jep.12614. Epub 2016 Aug 19.
- Background: PubMed 35858277Hallberg S, Rolfson O, Karppinen J, Schiottz-Christensen B, Stubhaug A, Rivano Fischer M, Gerdle B, Toresson Grip E, Gustavsson A, Robinson RL, Varenhorst C, Schepman P. Burden of disease and management of osteoarthritis and chronic low back pain: healthcare utilization and sick leave in Sweden, Norway, Finland and Denmark (BISCUITS): study design and patient characteristics of a real world data study. Scand J Pain. 2022 Jul 20;23(1):126-138. doi: 10.1515/sjpain-2021-0212. Print 2023 Jan 27.
- Background: PubMed 29573872Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, Turner JA, Maher CG; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018 Jun 9;391(10137):2368-2383. doi: 10.1016/S0140-6736(18)30489-6. Epub 2018 Mar 21.
- Background: PubMed 33275908Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.
- Background: PubMed 33069326GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
- Individual participant dataSharing planned: Undecided. In the planning stages of the trial, we have not taken measures to share data. This is due to our ethical permission.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual terapeut management in people with Backpain and Neck and Shoulder Pain, run by Karolinska Institutet 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 1 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: opening soon, as of the sponsor's last update on 17 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iben Axén, PhD (+46 70 44 00 618, iben.axen@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-perceived Global Perceived Effect (time frame: 12 months). 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 NCT07825116, which also lists 9 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 17 Sep 2026.