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NCT Number: NCT07825116

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

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.

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Key information

Conditions

Backpain Arthralgia Back Pain Joint Diseases Musculoskeletal Diseases Neck and Shoulder Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet , Stockholm 171 77 Solna

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual terapeut management

Other

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.

Primary outcomes

  1. 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"

Secondary outcomes

  1. Chronic pain

    Time frame: 12 months

  2. Activity limitations

    Time frame: 12 months

    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.

  3. Health-related quality of life

    Time frame: 12 months

    EuorQol-5 dimensions is a validated questionnaire that results in a score between 0 and 1(perfect health).

  4. Societal costs

    Time frame: 12 months

    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.

  5. Work Ability

    Time frame: 12 months

    Measures the balance between a person's individual resources (such as health, skills, and mental energy) and the actual demands of their job

  6. sickness absence

    Time frame: 12 months

    The number of days an individual has been off work because of neck and back pain

Other outcomes

  1. Quality of the assessment by manual therapists

    Time frame: 12 months

    A qualitative outcome collected in interviews with healthcare personell and patients

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Sophiahemmet University

Registry information

Acronym: ALIGN

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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