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Implementation of Evidence-based Guidelines for Assessment and Counseling of Patients With Neck and Back Pain in Health Care Centers

Implementation of Evidence-based Guidelines for Assessment and Counseling of Patients With Neck and Back Pain in Health Care Centers

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07825116
Acronym
ALIGN
Enrollment
600
Registered
2026-09-17
Start date
2026-11-01
Completion date
2030-12-31
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Backpain, Neck and Shoulder Pain

Keywords

community health centers, eveidence-based practice, manual therapy, interprofessionalrealtions, low backpain, neckpain

Brief 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. 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.

Interventions

OTHERManual terapeut management

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.

Sponsors

Karolinska Institutet
Lead SponsorOTHER
Sophiahemmet University
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

A hybrid, quasi-experimental Target Trial Emulation design employing mixed methods

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Patient-perceived Global Perceived Effect12 monthsThis 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"

Secondary

MeasureTime frameDescription
Chronic pain12 months
Activity limitations12 monthsRoland 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.
Health-related quality of life12 monthsEuorQol-5 dimensions is a validated questionnaire that results in a score between 0 and 1(perfect health).
Societal costs12 monthsCost 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.
Work Ability12 monthsMeasures the balance between a person's individual resources (such as health, skills, and mental energy) and the actual demands of their job
sickness absence12 monthsThe number of days an individual has been off work because of neck and back pain

Countries

Sweden

Contacts

CONTACTIben Axén, PhD
iben.axen@ki.se+46 70 44 00 618

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026