NCT02490722

Brief Summary

The aim of this study is to investigate effects of interdisciplinary group based patient education in patients with low back pain. The patients will be recruited to four group based patient education lessons during a two months period. The study is a randomized controlled trial and the patients will be randomized to standard treatment or standard treatment and patient education. The patient education will be led by physiotherapists, nurses and physicians. The outcomes are functions, pain, quality of life, self-efficacy, and depression. The data are reported in questionnaires.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 29, 2022

Status Verified

July 1, 2017

Enrollment Period

1.4 years

First QC Date

July 2, 2015

Last Update Submit

September 27, 2022

Conditions

Low Back Pain

Keywords

Patient educationEmpowerment

Outcome Measures

Primary Outcomes (1)

  • Change of functions

    Questionnaire

    Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.

Secondary Outcomes (5)

  • Change of pain

    Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.

  • Change of self-efficacy

    Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.

  • Change of quality of life

    Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.

  • Change of depression

    Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.

  • Change of physical function

    Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Four times two hours interdisciplinary patient education and usual care

Other: Patient education

Control

NO INTERVENTION

Usual care

Interventions

Patient educationOTHER

Four times two hours group based patient education

Intervention

Eligibility Criteria

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

You may qualify if:

  • adults
  • low back pain minimum scored 4 on numeric rating scale
  • able to conduct exercise training

You may not qualify if:

  • unable to understand Danish
  • psychiatric disorder
  • dementia
  • approaching operation
  • current or approaching settlement regarding working ability or compensation as a result of low back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordsjællands Hospital

Hillerød, Capital Region, 3400, Denmark

Location

Related Publications (3)

  • Heymans MW, van Tulder MW, Esmail R, Bombardier C, Koes BW. Back schools for non-specific low-back pain. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD000261. doi: 10.1002/14651858.CD000261.pub2.

    PMID: 15494995BACKGROUND

  • Dufour N, Thamsborg G, Oefeldt A, Lundsgaard C, Stender S. Treatment of chronic low back pain: a randomized, clinical trial comparing group-based multidisciplinary biopsychosocial rehabilitation and intensive individual therapist-assisted back muscle strengthening exercises. Spine (Phila Pa 1976). 2010 Mar 1;35(5):469-76. doi: 10.1097/BRS.0b013e3181b8db2e.

    PMID: 20147878BACKGROUND

  • Morone G, Paolucci T, Alcuri MR, Vulpiani MC, Matano A, Bureca I, Paolucci S, Saraceni VM. Quality of life improved by multidisciplinary back school program in patients with chronic non-specific low back pain: a single blind randomized controlled trial. Eur J Phys Rehabil Med. 2011 Dec;47(4):533-41. Epub 2011 Apr 20.

    PMID: 21508915BACKGROUND

MeSH Terms

Conditions

Low Back PainEmpowerment

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Stig Molsted, PhD

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 7, 2015

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

September 29, 2022

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)