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NCT Number: NCT05531201

Evaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic and at Risk of Chronic Low Back Pain in Primary Care

Low back pain is a public health problem with major individual and socio-economic repercussions. In primary care, strong disparities are observed in the management of low back pain patients. While general practitioners (GPs) and physiotherapists appear as two essential first-line caregivers, collaboration between these professionals remains underdeveloped, most often characterized by a lack of consultation or coordination. Systematic increased interprofessional collaboration is likely to improve the results of the care pathway, by optimizing the existing care offer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maison de Santé Pluriprofessionnelle Universitaire

Fontainebleau, 77300, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adult patients between the ages of 18 and 65

  • Patients consulting their GP for a first or new eisode of acute low back pain (more than 12 months from the previous one) with a STarT Back screening tool score greater than 3.
  • OR low back pain at risk of chronicity (presence of yellow flags, according to the recommendation of the High Health Authority (HAS) of 2019
  • OR recurrent low back pain: in the event of recurrence of low back pain within 12 months after the previous episode, then considered to be at risk of chronicity
  • OR having chronic low back pain (low back pain for more than 3 months)
  • Patients benefiting from the general social security system
  • Patients who understand and speak French fluently
  • Patients who have given their consent after having received complete information on the protocol

Exclusion criteria

  • Minor patients
  • Pregnant women (declared pregnancy) or immediately postpartum (up to 3 months)
  • Patients with "red flags" (serious neurological impairment, cancer, infection, fracture or inflammatory disease), according to the 2019 HAS recommendation
  • Patients referred immediately for imaging or specialist advice during the first consultation with the GP (suspicion of underlying pathology)
  • Patients with no history of acute low back pain, at low risk of chronicity (STarT Back screening tool score less than or equal to 3)
  • Patients with a contraindication to rehabilitation by physiotherapy
  • Patients who have already undergone spine surgery
  • Patients with cognitive impairment
  • Patients whose life expectancy is less than 12 months
  • Patients under guardianship or curatorship, under judicial protection or safeguard of justice
  • Patients not affiliated to the general social security system
  • Patients with difficulties in understanding the French language
  • Patients with an inability to give express consent

Treatment and study plan

collaboration general practitioner and physiotherapist

Procedure

training general practitioner and physiotherapist

Primary outcomes

  1. Disability at 3 months

    Time frame: 3 months

    Absolute change in overall Oswestry Disability Index (ODI) scale score between 0 and 3 months. Total score ranging from 0 (no functional disability) to 100 (severe functional disability).

Secondary outcomes

  1. Disability at 12 months

    Time frame: 12 months

    Absolute change in overall ODI scale score between 0 and 12 months. Total score ranging from 0 (no functional disability) to 100 (severe functional disability).

  2. Health-related quality of life at 3 months

    Time frame: 3 months

    Absolute change of health-related quality of life by the EuroQol 5 Dimensions scale (EQ-5D) between 0 and 3 months and between 0 and 12 months

  3. Health-related quality of life at 12 months

    Time frame: 12 months

    Absolute change of health-related quality of life by the EuroQol 5 Dimensions scale (EQ-5D) between 0 and 12 months

  4. Evaluation of the course of care: compliance

    Time frame: 12 months

    number (%) of patients having followed the entire course of care

  5. Evaluation of the course of care: number of consultations

    Time frame: 12 months

    total number of consultations with GPs and physiotherapists (PTs)

  6. Evaluation of the course of care: medical imaging

    Time frame: 12 months

    total number of medical imaging related to low back during the follow up

  7. Evaluation of the course of care: total cost

    Time frame: 12 months

    total cost (in euros €) of healthcare pathway in the two groups

  8. Evaluation of effective collaborative practices

    Time frame: 12 months

    qualitative analysis of GP/PT collaboration using semi-structured interviews with professionals

Sponsors and collaborators

Lead sponsor

CNGE Conseil

Other

Registry information

Official study title

Evaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic Low Back Pain and Patients at Risk of Chronic Low Back Pain in Primary Care: a Cluster Randomized Controlled Trial

Acronym: EFFIBACK

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 7, 2022
Registry last updated
Feb 11, 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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