Effect of Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain

September 27, 2022 updated by: Nordsjaellands Hospital

The Effect of Interdisciplinary Group Based Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Design: Randomized controlled trial; intervention study. Patients: Patients with low back pain; referred to Nordsjaellands Hospital, Denmark. Inclusion criteria: adults, low back pain minimum scored 4 on numeric rating scale, able to conduct exercise training. Exclusion criteria: 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. Intervention: Randomization to usual care or usual care and four times two hours group based patient education with an interdisciplinary focus on self-management of low back pain. The patient education will be delivered by physiotherapists, nurses and physicians. Outcome: functions, pain, quality of life, self-efficacy, and depression. The data are reported in questionnaires. Sample size: 74 participants.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Hovedstaden
      • Hillerød, Region Hovedstaden, Denmark, 3400
        • Nordsjællands Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual care
Active Comparator: Intervention
Four times two hours interdisciplinary patient education and usual care
Other: Patient education
Four times two hours group based patient education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of functions
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of pain
Time Frame: 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.
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.
Change of self-efficacy
Time Frame: 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.
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.
Change of quality of life
Time Frame: 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.
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.
Change of depression
Time Frame: 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.
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.
Change of physical function
Time Frame: 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.
Performance test
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordsjaellands Hospital

Investigators

  • Principal Investigator: Stig Molsted, PhD, Nordsjællands Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 6, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15006949

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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