Effect of Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain
Primary Purpose
Low Back Pain
Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Patient education
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Patient education, Empowerment
Eligibility Criteria
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
Sites / Locations
- Nordsjællands Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Control
Arm Description
Four times two hours interdisciplinary patient education and usual care
Usual care
Outcomes
Primary Outcome Measures
Change of functions
Questionnaire
Secondary Outcome Measures
Change of pain
Questionnaire
Change of self-efficacy
Questionnaire
Change of quality of life
Questionnaire
Change of depression
Questionnaire
Change of physical function
Performance test
Full Information
NCT ID
NCT02490722
First Posted
July 2, 2015
Last Updated
September 27, 2022
Sponsor
Nordsjaellands Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02490722
Brief Title
Effect of Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain
Official Title
The Effect of Interdisciplinary Group Based Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordsjaellands Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Patient education, Empowerment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Four times two hours interdisciplinary patient education and usual care
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Patient education
Intervention Description
Four times two hours group based patient education
Primary Outcome Measure Information:
Title
Change of functions
Description
Questionnaire
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.
Secondary Outcome Measure Information:
Title
Change of pain
Description
Questionnaire
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.
Title
Change of self-efficacy
Description
Questionnaire
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.
Title
Change of quality of life
Description
Questionnaire
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.
Title
Change of depression
Description
Questionnaire
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.
Title
Change of physical function
Description
Performance test
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stig Molsted, PhD
Organizational Affiliation
Nordsjællands Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nordsjællands Hospital
City
Hillerød
State/Province
Region Hovedstaden
ZIP/Postal Code
3400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15494995
Citation
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;(4):CD000261. doi: 10.1002/14651858.CD000261.pub2.
Results Reference
background
PubMed Identifier
20147878
Citation
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.
Results Reference
background
PubMed Identifier
21508915
Citation
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.
Results Reference
background
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Effect of Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain
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