---
title: "Low Back Pain - What's Next? Stratified Care Compared to Current Practice"
nct_id: NCT02612467
overall_status: COMPLETED
phase: NA
sponsor: Region of Southern Denmark
study_type: INTERVENTIONAL
primary_condition: Low Back Pain
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02612467.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02612467"
ct_last_update_post_date: 2019-09-10
last_seen_at: "2026-05-12T06:31:57.583Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Low Back Pain - What's Next? Stratified Care Compared to Current Practice

**Official Title:** The Effectiveness of a Stratified Care Model for Non-specific Low Back Pain in Danish Primary Care Compared to Current Practice in a Randomised Controlled Trial

**NCT ID:** [NCT02612467](https://clinicaltrials.gov/study/NCT02612467)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 333
- **Lead Sponsor:** Region of Southern Denmark
- **Collaborators:** Herning Hospital, Research Unit of General Practice, Odense, Spine Centre of Southern Denmark, Keele University
- **Conditions:** Low Back Pain
- **Start Date:** 2015-11
- **Completion Date:** 2018-12-15
- **CT.gov Last Update:** 2019-09-10

## Brief Summary

Background Studies in the United Kingdom find the stratified care model of the STarT Back Tool (SBT) to be superior to usual care in primary care low back pain (LBP) patients. However, considerations on differences in health care and social systems across countries are required before taking steps towards any recommendations of implementing stratified care into other health care services.

Objective To investigate the effectiveness of the stratified care model of the SBT, when embedded into the regional disease management programs on LBP in primary care as compared to current best practice care.

## Detailed Description

Methods The study is a two-armed randomized controlled trial in Danish primary health care setting. In total 700 patients are included in the study.

The patients are randomised automatically by a developed database to; 1) Stratified care (treatment matched to stratification according to SBT) or 2) Control treatment (treatment based solely on clinical reasoning).

All data including patient consent is collected and monitored using a web-based data management system.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* patients found eligible for referral to physiotherapy by the general practitioner (GP)
* 18 years and above
* understand Danish language.

Exclusion Criteria:

* Serious pathology (malignancy, inflammatory arthritis, etc.),
* serious nerve root compression (cauda equina, paresis \<3),
* influential comorbidity, psychiatric illness, personality disorder, spinal surgery during the last 6 months, pregnancy, or already receiving physiotherapy treatment.
```

## Arms

- **Stratified care** (EXPERIMENTAL) — Patients are stratified into low, medium, high risk of poor outcome. Stratified care are delivered by special trained physiotherapists according to risk group
- **Current care** (ACTIVE_COMPARATOR) — Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.

## Interventions

- **Stratified care** (OTHER) — Patients are stratified according to the SBT subgroups (low, medium and high risk) and the appropriate matched intervention will be delivered accordingly.

Low risk: Reassuring information. Onwards referral, investigation or further treatment is not recommended Medium risk: In addition to reassuring information patients receive evidence based individualised treatment focusing on restoring function (targeting back pain, leg pain, co-morbid pain and disability) High risk : In addition to medium risk treatment patients will receive individualised psychologically informed physiotherapy aiming to reduce pain and disability.
- **Current care** (OTHER) — Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.

## Primary Outcomes

- **Patient reported change measured by the Roland Morris Disability Questionnaire** _(time frame: 3 and 12 months)_ — Change in disability measured by the Roland Morris Disability Questionnaire at 3 and 12 months (RMDQ)

## Secondary Outcomes

- **Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire** _(time frame: 12 months)_
- **Change in pain intensity measured on a numeric range scale** _(time frame: 3 and 12 months)_
- **Time off work assessed by the Danish National Register on Public Transfer Payments (DREAM)** _(time frame: 3 and 12 months)_
- **Time off work monitored by standardized patient reported data** _(time frame: 3 and 12 months)_
- **Patient reported global change measured by the questionnaire "Global Impression of Change"** _(time frame: 3 and 12 months)_

## Locations (2)

- Department of Occ. Medicine, Herning, Central Region, Denmark
- Centre for Quality, Middelfart, Southern Denmark, Denmark

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of occ. medicine|herning|central region|denmark` — added _(2026-05-12)_
- `locations.centre for quality|middelfart|southern denmark|denmark` — added _(2026-05-12)_

---

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