Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

16 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

600

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Iben Axén, PhD
  • Número de teléfono: +46 70 44 00 618
  • Correo electrónico: iben.axen@ki.se

Ubicaciones de estudio

      • Stockholm, Suecia
        • Karolinska Institutet , Stockholm 171 77 Solna
        • Contacto:
          • Iben Axén, PhD
          • Número de teléfono: +46 70 44 00 618
          • Correo electrónico: iben.axen@ki.se

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: N / A
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient-perceived Global Perceived Effect
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Chronic pain
Periodo de tiempo: 12 months
12 months
Activity limitations
Periodo de tiempo: 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
Periodo de tiempo: 12 months
EuorQol-5 dimensions is a validated questionnaire that results in a score between 0 and 1(perfect health).
12 months
Societal costs
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 12 months
The number of days an individual has been off work because of neck and back pain
12 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Quality of the assessment by manual therapists
Periodo de tiempo: 12 months
A qualitative outcome collected in interviews with healthcare personell and patients
12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

31 de agosto de 2030

Finalización del estudio (Estimado)

31 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

10 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de septiembre de 2026

Publicado por primera vez (Actual)

17 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir