NCT02612467

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

3.1 years

First QC Date

November 16, 2015

Last Update Submit

September 9, 2019

Conditions

Low Back Pain

Keywords

start back toolstratified caretargeted treatment

Outcome Measures

Primary Outcomes (1)

  • Patient reported change measured by the Roland Morris Disability Questionnaire

    Change in disability measured by the Roland Morris Disability Questionnaire at 3 and 12 months (RMDQ)

    3 and 12 months

Secondary Outcomes (5)

  • Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire

    12 months

  • Change in pain intensity measured on a numeric range scale

    3 and 12 months

  • Time off work assessed by the Danish National Register on Public Transfer Payments (DREAM)

    3 and 12 months

  • Time off work monitored by standardized patient reported data

    3 and 12 months

  • Patient reported global change measured by the questionnaire "Global Impression of Change"

    3 and 12 months

Study Arms (2)

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

Other: Stratified care

Current care

ACTIVE COMPARATOR

Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.

Other: Current care

Interventions

Stratified careOTHER

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.

Stratified care
Current careOTHER

Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.

Current care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Occ. Medicine

Herning, Central Region, 7400, Denmark

Location

Centre for Quality

Middelfart, Southern Denmark, 5500, Denmark

Location

Related Publications (4)

  • Morso L, Albert H, Kent P, Manniche C, Hill J. Translation and discriminative validation of the STarT Back Screening Tool into Danish. Eur Spine J. 2011 Dec;20(12):2166-73. doi: 10.1007/s00586-011-1911-6. Epub 2011 Jul 19.

    PMID: 21769444BACKGROUND

  • Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011 Oct 29;378(9802):1560-71. doi: 10.1016/S0140-6736(11)60937-9. Epub 2011 Sep 28.

    PMID: 21963002RESULT

  • Morso L, Olsen Rose K, Schiottz-Christensen B, Sowden G, Sondergaard J, Christiansen DH. Effectiveness of stratified treatment for back pain in Danish primary care: A randomized controlled trial. Eur J Pain. 2021 Oct;25(9):2020-2038. doi: 10.1002/ejp.1818. Epub 2021 Jul 2.

    PMID: 34101953DERIVED

  • Morso L, Schiottz-Christensen B, Sondergaard J, Andersen NV, Pedersen F, Olsen KR, Jensen MS, Hill J, Christiansen DH. The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial. Trials. 2018 Jun 8;19(1):315. doi: 10.1186/s13063-018-2685-5.

    PMID: 29884217DERIVED

Related Links

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lars Morsø, Ph.D

    Centre for Quality, Institute for Regional Healthresearch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 23, 2015

Study Start

November 1, 2015

Primary Completion

December 15, 2018

Study Completion

December 15, 2018

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations

DK(2)