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

September 16, 2026 updated by: Iben Axen, Karolinska Institutet

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Iben Axén, PhD
  • Phone Number: +46 70 44 00 618
  • Email: iben.axen@ki.se

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska Institutet , Stockholm 171 77 Solna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MT management
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.
Other: Manual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic pain
Time Frame: 12 months
12 months
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.
12 months
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).
12 months
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.
12 months
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
12 months
sickness absence
Time Frame: 12 months
The number of days an individual has been off work because of neck and back pain
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of the assessment by manual therapists
Time Frame: 12 months
A qualitative outcome collected in interviews with healthcare personell and patients
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Sophiahemmet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

August 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

September 10, 2026

First Submitted That Met QC Criteria

September 16, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIIMMIIB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

In the planning stages of the trial, we have not taken measures to share data. This is due to our ethical permission.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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